Drug Abuse
Conditions
Brief summary
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
Detailed description
This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).
Interventions
DEVICEPrevict Drugs
Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.
Sponsors
Kontigo Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female healthy volunteers * Age 18 to 70 years * BMI between 18.5-30 kg/m2 * Weight between 50-100 kg * Healthy as determined by the investigator or designee based on pre-study medical and surgical history and a health examination at enrollment * Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and at visit 2 and must agree to use a medically acceptable contraception from enrollment until study completion * No current drug usage defined as a negative urine drug test at enrollment and at visit 2 * Able to use Previct Drugs after initial training (defined as successfully performing a test after trying maximum three times per measurement) * Been informed of the nature, the scope, and the relevance of the clinical investigation * Voluntarily agreed on participation and has duly singed the Informed Consent Form
Exclusion criteria
* Participating in another clinical investigation which may affect the study outcome according to clinical judgement * Pregnancy or Lactating * Blind * Deaf * Abnormal ECG (QTc time \>450 ms) at enrollment * Current or recent history of alcohol misuse assessed by AUDIT where ≥6 points for women or ≥8 points for men indicates a potential misuse * Current or history of psychiatric disorder or drug misuse assessed by M.I.N.I where the outcome will be based on clinical judgement * Any disease or condition that may influence pupillary reflexes based on clinical judgement * Undergone eye surgery that may influence pupillary reflexes based on clinical judgement * Ongoing treatment with medications which may interfere with eye measurements based on clinical judgement * Ongoing treatment with medications which may interfere with any of the medicinal products to be used * History or presence of allergy or serious reaction to the medicinal products to be used * History or presence of cardiovascular disease, e.g., arteriosclerosis, hypertension, or cor pulmonale * History or presence of sleep-related breath disorder * History or presence of gastrointestinal disease, e.g., paralytic ileus, acute abdomen, delayed gastric emptying, or chronic constipation * History or presence of pulmonary disease, e.g., acute pulmonary insufficiency, severe respiratory depression with hypoxia, chronic obstructive lung disease, or bronchial asthma * History or presence of autoimmune neuromuscular disease, e.g., myasthenia gravis * Not able to read or understand the local language * Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate * That according to the Declaration of Helsinki is deemed unsuitable for study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an Attempt, and the successful transformation is denoted a Successful attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an Attempt, and the successful transformation is denoted a Successful attempt. |
| Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered changed if the difference between averages at baseline and peak concentration is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. |
| Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered correlated if the slope in a linear regression is significantly different from zero (p\<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. |
| Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered changed if the difference between averages at baseline and at 5 hours is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. |
| Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | Day 7 +/- 2 days (Visit 2) | For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table. |
| Usability Questionnaire - Question 1 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options: * Not understandable * Could only understand some parts * Could understand most parts * Could understand almost every part * Fully understandable |
| Usability Questionnaire - Question 2 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options: * Yes * No |
| Usability Questionnaire - Question 4 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options: * Very easy to understand * Easy to understand * Nor easy or difficult to understand * Difficult to understand * Very difficult to understand |
| Usability Questionnaire - Question 5 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options: * Yes * No |
| Usability Questionnaire - Question 7 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform |
| Usability Questionnaire - Question 8 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options: * Yes * No |
| Usability Questionnaire - Question 9 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something: Response options: * One occasion * Several occasions * Most occasions * All occasions |
| Usability Questionnaire - Question 10 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end. Response options: * \< 5 minutes * 5-7 minutes * \> 7 minutes |
| Usability Questionnaire - Question 11 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs? Response options: * Yes * Most of the times * I did not receive any notifications |
| Usability Questionnaire - Question 26 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes |
| Usability Questionnaire - Question 13 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs? Response options: * Yes * No |
| Usability Questionnaire - Question 15 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance? Response options: * One occasion * Several occasions * Most occasions * All occasions |
| Usability Questionnaire - Question 16 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 18 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform |
| Usability Questionnaire - Question 24 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform |
| Usability Questionnaire - Question 20 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes |
| Usability Questionnaire - Question 21 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions |
| Usability Questionnaire - Question 23 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 27 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions |
| Usability Questionnaire - Question 29 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform |
| Usability Questionnaire - Question 31 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform |
| Usability Questionnaire - Question 33 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes |
| Usability Questionnaire - Question 34 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions |
| Usability Questionnaire - Question 12 | Day 7 +/- 2 days (Visit 2) | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs? Response options: * No * Yes |
Countries
Netherlands
Participant flow
Pre-assignment details
48 subjects were included in the Full Analysis Set (FAS), 12 subjects per medicinal product type.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers With Single Application of Phenethylamines (D1) Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group. | 12 |
| Healthy Volunteers With Single Application of Benzodiazepines (D2) Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiazepines (D2) allocated to this specific group. | 12 |
| Healthy Volunteers With Single Application of Cannabinoids (D3) Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group. | 12 |
| Healthy Volunteers With Single Application of Opioids (D4) Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group. | 12 |
| Total | 48 |
Baseline characteristics
| Characteristic | Total | Healthy Volunteers With Single Application of Benzodiazepines (D2) | Healthy Volunteers With Single Application of Cannabinoids (D3) | Healthy Volunteers With Single Application of Phenethylamines (D1) | Healthy Volunteers With Single Application of Opioids (D4) |
|---|---|---|---|---|---|
| Age, Continuous | 27.48 Years STANDARD_DEVIATION 15 | 27.92 Years STANDARD_DEVIATION 14.68 | 27.75 Years STANDARD_DEVIATION 17.35 | 26.25 Years STANDARD_DEVIATION 12.9 | 28.00 Years STANDARD_DEVIATION 16.6 |
| Audit questionnaire | 4.46 Score on a scale STANDARD_DEVIATION 1.79 | 3.83 Score on a scale STANDARD_DEVIATION 2.12 | 4.5 Score on a scale STANDARD_DEVIATION 2.11 | 4.42 Score on a scale STANDARD_DEVIATION 1.08 | 5.08 Score on a scale STANDARD_DEVIATION 1.62 |
| Eye color Eye color - amber | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eye color Eye color - black | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eye color Eye color - blue | 24 Participants | 2 Participants | 7 Participants | 7 Participants | 8 Participants |
| Eye color Eye color - brown | 13 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants |
| Eye color Eye color - green | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants |
| Eye color Eye color - grey | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Eye color Eye color - other | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Sex: Female, Male Female | 34 Participants | 9 Participants | 7 Participants | 10 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 3 Participants | 5 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 7 / 12 | 4 / 12 | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an Attempt, and the successful transformation is denoted a Successful attempt.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 290 Number of attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 279 Number of attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Redness (RED) | 314 Number of attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Tremor (TR) | 295 Number of attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Non-convergence (NC) | 295 Number of attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Tremor (TR) | 282 Number of attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 297 Number of attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Redness (RED) | 317 Number of attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 242 Number of attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Non-convergence (NC) | 286 Number of attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Tremor (TR) | 319 Number of attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Non-convergence (NC) | 317 Number of attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 300 Number of attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 302 Number of attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Redness (RED) | 312 Number of attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 307 Number of attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 282 Number of attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Non-convergence (NC) | 300 Number of attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Tremor (TR) | 295 Number of attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | Successful attempts - Redness (RED) | 325 Number of attempts |
Secondary
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population. Obtained measurement data included for all subjects where available. Data for 500 Lux Kay feature Dbase missing for one subject in group D4 (opioid group). Consequently, data from 11 subjects presented for this variable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
| Single Application of Phenethylamines (D1) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 12 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 12 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Benzodiazepines (D2) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 12 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids (D3) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 2 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 11 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 10 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 1 Number of participants |
| Single Application of Opioids (D4) | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 10 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 11 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 1 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 1 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 1 Number of participants |
| Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 1 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 10 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 1 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 1 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 11 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 8 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 3 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 9 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 1 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 1 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 11 Number of participants |
| Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 2 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 12 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 12 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 0 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 0 Number of participants |
| Single Application of Opioids - 50 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration, missing key feature data | 1 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of true negative | 11 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline, missing key feature data | 1 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At baseline number of false positive | 0 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of true positive | 11 Number of participants |
| Single Application of Opioids - 500 Lux Key Feature Dbase | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | At peak concentration number of false negative | 0 Number of participants |
Comparison: The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.p-value: <0.05Regression, Logistic
Comparison: The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.p-value: <0.05Regression, Logistic
Comparison: The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.p-value: <0.05Regression, Logistic
Comparison: The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.p-value: <0.05Regression, Logistic
Comparison: The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.p-value: <0.05Regression, Logistic
p-value: <0.05Regression, Logistic
Secondary
Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition.
For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered correlated if the slope in a linear regression is significantly different from zero (p\<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 50 LUX | 5 Number of key features |
| Single Application of Phenethylamines (D1) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 500 LUX | 7 Number of key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 50 LUX | 6 Number of key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 500 LUX | 4 Number of key features |
| Single Application of Cannabinoids (D3) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 500 LUX | 2 Number of key features |
| Single Application of Cannabinoids (D3) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 50 LUX | 7 Number of key features |
| Single Application of Opioids (D4) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 50 LUX | 10 Number of key features |
| Single Application of Opioids (D4) | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | 500 LUX | 9 Number of key features |
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0006Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0002Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0285Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.012Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0174Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.013Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0068Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0485Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0031Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0036Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0089Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0239Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0435Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0126Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0294Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0204Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0004Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0013Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0003Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0096Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0003Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0063Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0018Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0134Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0313Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0481Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0171Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: 0.0007Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Comparison: The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + mp-value: <0.0001Regression, Linear
Secondary
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered changed if the difference between averages at baseline and at 5 hours is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 50 LUX | 6 Number of Key features |
| Single Application of Phenethylamines (D1) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 500 LUX | 5 Number of Key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 500 LUX | 5 Number of Key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 50 LUX | 1 Number of Key features |
| Single Application of Cannabinoids (D3) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 50 LUX | 2 Number of Key features |
| Single Application of Cannabinoids (D3) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 500 LUX | 0 Number of Key features |
| Single Application of Opioids (D4) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 50 LUX | 8 Number of Key features |
| Single Application of Opioids (D4) | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | 500 LUX | 6 Number of Key features |
Secondary
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered changed if the difference between averages at baseline and peak concentration is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 50 Lux | 5 Number of key features |
| Single Application of Phenethylamines (D1) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 500 Lux | 5 Number of key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 500 Lux | 3 Number of key features |
| Single Application of Benzodiazepines (D2) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 50 Lux | 1 Number of key features |
| Single Application of Cannabinoids (D3) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 50 Lux | 4 Number of key features |
| Single Application of Cannabinoids (D3) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 500 Lux | 2 Number of key features |
| Single Application of Opioids (D4) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 50 Lux | 7 Number of key features |
| Single Application of Opioids (D4) | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | 500 Lux | 7 Number of key features |
Secondary
Usability Questionnaire - Question 1
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options: * Not understandable * Could only understand some parts * Could understand most parts * Could understand almost every part * Fully understandable
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 1 | Fully understandable | 11 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 1 | Could understand almost every part | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 1 | Not understandable | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 1 | Could only understand some parts | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 1 | Could understand most parts | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 1 | Could understand most parts | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 1 | Not understandable | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 1 | Could only understand some parts | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 1 | Could understand almost every part | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 1 | Fully understandable | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 1 | Could understand almost every part | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 1 | Fully understandable | 7 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 1 | Could only understand some parts | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 1 | Could understand most parts | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 1 | Not understandable | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 1 | Fully understandable | 9 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 1 | Not understandable | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 1 | Could understand most parts | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 1 | Could understand almost every part | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 1 | Could only understand some parts | 0 Participants |
Secondary
Usability Questionnaire - Question 10
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end. Response options: * \< 5 minutes * 5-7 minutes * \> 7 minutes
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 10 | < 5 minutes | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 10 | > 7 minutes | 2 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 10 | 5-7 minutes | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 10 | < 5 minutes | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 10 | > 7 minutes | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 10 | 5-7 minutes | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 10 | 5-7 minutes | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 10 | < 5 minutes | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 10 | > 7 minutes | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 10 | < 5 minutes | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 10 | > 7 minutes | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 10 | 5-7 minutes | 7 Participants |
Secondary
Usability Questionnaire - Question 11
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs? Response options: * Yes * Most of the times * I did not receive any notifications
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 11 | Yes | 2 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 11 | I did not receive any notifications | 8 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 11 | Most of the times | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 11 | Yes | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 11 | I did not receive any notifications | 8 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 11 | Most of the times | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 11 | Most of the times | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 11 | Yes | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 11 | I did not receive any notifications | 8 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 11 | Yes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 11 | I did not receive any notifications | 8 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 11 | Most of the times | 0 Participants |
Secondary
Usability Questionnaire - Question 12
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs? Response options: * No * Yes
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 12 | No | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 12 | Yes | 7 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 12 | Yes | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 12 | No | 9 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 12 | Yes | 9 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 12 | No | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 12 | Yes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 12 | No | 8 Participants |
Secondary
Usability Questionnaire - Question 13
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs? Response options: * Yes * No
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 13 | Yes | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 13 | No | 12 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 13 | No | 11 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 13 | Yes | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 13 | Yes | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 13 | No | 10 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 13 | Yes | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 13 | No | 10 Participants |
Secondary
Usability Questionnaire - Question 15
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance? Response options: * One occasion * Several occasions * Most occasions * All occasions
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | Missing | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | Not applicable | 11 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | Several occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | Most occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | One occasion | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 15 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | Several occasions | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | Most occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | One occasion | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | Missing | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 15 | Not applicable | 11 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | Several occasions | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | One occasion | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | Missing | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | All occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | Not applicable | 10 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 15 | Most occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | Not applicable | 10 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | One occasion | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | Several occasions | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | Most occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | All occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 15 | Missing | 0 Participants |
Secondary
Usability Questionnaire - Question 16
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 16 | Nor easy or difficult | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 16 | Difficult | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 16 | Very easy | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 16 | Easy | 7 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 16 | Very difficult | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 16 | Nor easy or difficult | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 16 | Difficult | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 16 | Easy | 10 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 16 | Very easy | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 16 | Very difficult | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 16 | Nor easy or difficult | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 16 | Very easy | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 16 | Easy | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 16 | Difficult | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 16 | Very difficult | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 16 | Difficult | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 16 | Easy | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 16 | Very easy | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 16 | Nor easy or difficult | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 16 | Very difficult | 0 Participants |
Secondary
Usability Questionnaire - Question 18
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 18 | Difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 18 | Very easy to perform | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 18 | Very difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 18 | Nor easy or difficult to perform | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 18 | Easy to perform | 6 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 18 | Nor easy or difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 18 | Difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 18 | Very easy to perform | 6 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 18 | Easy to perform | 6 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 18 | Very difficult to perform | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 18 | Nor easy or difficult to perform | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 18 | Very easy to perform | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 18 | Easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 18 | Difficult to perform | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 18 | Very difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 18 | Difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 18 | Easy to perform | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 18 | Very easy to perform | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 18 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 18 | Very difficult to perform | 0 Participants |
Secondary
Usability Questionnaire - Question 2
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options: * Yes * No
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 2 | Yes | 11 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 2 | No | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 2 | No | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 2 | Yes | 12 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 2 | No | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 2 | Yes | 12 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 2 | Yes | 12 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 2 | No | 0 Participants |
Secondary
Usability Questionnaire - Question 20
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 20 | < 1 minute | 3 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 20 | > 3 minutes | 2 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 20 | 1-2 minutes | 7 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 20 | < 1 minute | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 20 | > 3 minutes | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 20 | 1-2 minutes | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 20 | 1-2 minutes | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 20 | < 1 minute | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 20 | > 3 minutes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 20 | < 1 minute | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 20 | > 3 minutes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 20 | 1-2 minutes | 6 Participants |
Secondary
Usability Questionnaire - Question 21
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 21 | Most occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 21 | One occasion | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 21 | All occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 21 | Several occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 21 | No occasion | 7 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 21 | Several occasions | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 21 | Most occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 21 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 21 | One occasion | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 21 | No occasion | 8 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 21 | Several occasions | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 21 | No occasion | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 21 | One occasion | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 21 | Most occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 21 | All occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 21 | Most occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 21 | One occasion | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 21 | No occasion | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 21 | Several occasions | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 21 | All occasions | 0 Participants |
Secondary
Usability Questionnaire - Question 23
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 23 | Very easy | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 23 | Difficult | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 23 | Easy | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 23 | Very difficult | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 23 | Nor easy or difficult | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 23 | Very easy | 6 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 23 | Very difficult | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 23 | Easy | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 23 | Difficult | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 23 | Nor easy or difficult | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 23 | Nor easy or difficult | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 23 | Difficult | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 23 | Very difficult | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 23 | Very easy | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 23 | Easy | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 23 | Nor easy or difficult | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 23 | Easy | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 23 | Very difficult | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 23 | Difficult | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 23 | Very easy | 4 Participants |
Secondary
Usability Questionnaire - Question 24
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 24 | Difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 24 | Easy to perform | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 24 | Very difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 24 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 24 | Very easy to perform | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 24 | Nor easy or difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 24 | Difficult to perform | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 24 | Very difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 24 | Easy to perform | 6 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 24 | Very easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 24 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 24 | Very easy to perform | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 24 | Easy to perform | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 24 | Difficult to perform | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 24 | Very difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 24 | Difficult to perform | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 24 | Easy to perform | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 24 | Very easy to perform | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 24 | Nor easy or difficult to perform | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 24 | Very difficult to perform | 0 Participants |
Secondary
Usability Questionnaire - Question 26
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 26 | > 3 minutes | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 26 | < 1 minute | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 26 | 1-2 minutes | 7 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 26 | > 3 minutes | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 26 | 1-2 minutes | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 26 | < 1 minute | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 26 | < 1 minute | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 26 | 1-2 minutes | 7 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 26 | > 3 minutes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 26 | > 3 minutes | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 26 | < 1 minute | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 26 | 1-2 minutes | 7 Participants |
Secondary
Usability Questionnaire - Question 27
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 27 | No occasion | 10 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 27 | One occasion | 2 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 27 | Most occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 27 | All occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 27 | Several occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 27 | Most occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 27 | No occasion | 9 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 27 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 27 | Several occasions | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 27 | One occasion | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 27 | One occasion | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 27 | No occasion | 7 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 27 | Several occasions | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 27 | Most occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 27 | All occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 27 | All occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 27 | Most occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 27 | One occasion | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 27 | Several occasions | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 27 | No occasion | 6 Participants |
Secondary
Usability Questionnaire - Question 29
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 29 | Very difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 29 | Easy to perform | 6 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 29 | Difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 29 | Nor easy or difficult to perform | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 29 | Very easy to perform | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 29 | Very difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 29 | Very easy to perform | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 29 | Easy to perform | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 29 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 29 | Difficult to perform | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 29 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 29 | Very difficult to perform | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 29 | Easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 29 | Very easy to perform | 4 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 29 | Difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 29 | Very difficult to perform | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 29 | Difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 29 | Nor easy or difficult to perform | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 29 | Easy to perform | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 29 | Very easy to perform | 1 Participants |
Secondary
Usability Questionnaire - Question 31
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 31 | Difficult to perform | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 31 | Easy to perform | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 31 | Very difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 31 | Nor easy or difficult to perform | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 31 | Very easy to perform | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 31 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 31 | Difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 31 | Very difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 31 | Easy to perform | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 31 | Very easy to perform | 7 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 31 | Nor easy or difficult to perform | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 31 | Very easy to perform | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 31 | Easy to perform | 6 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 31 | Difficult to perform | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 31 | Very difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 31 | Difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 31 | Easy to perform | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 31 | Very easy to perform | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 31 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 31 | Very difficult to perform | 0 Participants |
Secondary
Usability Questionnaire - Question 33
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 33 | < 1 minute | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 33 | > 3 minutes | 3 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 33 | 1-2 minutes | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 33 | < 1 minute | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 33 | > 3 minutes | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 33 | 1-2 minutes | 9 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 33 | 1-2 minutes | 8 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 33 | < 1 minute | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 33 | > 3 minutes | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 33 | < 1 minute | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 33 | > 3 minutes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 33 | 1-2 minutes | 7 Participants |
Secondary
Usability Questionnaire - Question 34
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 34 | Most occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 34 | No occasion | 5 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 34 | One occasion | 3 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 34 | Several occasions | 4 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 34 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 34 | Several occasions | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 34 | One occasion | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 34 | Most occasions | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 34 | No occasion | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 34 | All occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 34 | Most occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 34 | All occasions | 1 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 34 | No occasion | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 34 | Several occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 34 | One occasion | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 34 | All occasions | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 34 | One occasion | 2 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 34 | Several occasions | 5 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 34 | Most occasions | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 34 | No occasion | 3 Participants |
Secondary
Usability Questionnaire - Question 4
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options: * Very easy to understand * Easy to understand * Nor easy or difficult to understand * Difficult to understand * Very difficult to understand
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 4 | Difficult to understand | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 4 | Easy to understand | 1 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 4 | Very difficult to understand | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 4 | Nor easy or difficult to understand | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 4 | Very easy to understand | 11 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 4 | Nor easy or difficult to understand | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 4 | Difficult to understand | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 4 | Very difficult to understand | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 4 | Easy to understand | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 4 | Very easy to understand | 8 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 4 | Nor easy or difficult to understand | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 4 | Very easy to understand | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 4 | Easy to understand | 7 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 4 | Difficult to understand | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 4 | Very difficult to understand | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 4 | Difficult to understand | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 4 | Easy to understand | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 4 | Very easy to understand | 6 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 4 | Nor easy or difficult to understand | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 4 | Very difficult to understand | 0 Participants |
Secondary
Usability Questionnaire - Question 5
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options: * Yes * No
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 5 | Yes | 12 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 5 | No | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 5 | Yes | 10 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 5 | No | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 5 | No | 3 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 5 | Yes | 9 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 5 | No | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 5 | Yes | 11 Participants |
Secondary
Usability Questionnaire - Question 7
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 7 | Difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 7 | Easy to perform | 7 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 7 | Very difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 7 | Nor easy or difficult to perform | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 7 | Very easy to perform | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 7 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 7 | Difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 7 | Very difficult to perform | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 7 | Easy to perform | 5 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 7 | Very easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 7 | Nor easy or difficult to perform | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 7 | Very easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 7 | Easy to perform | 5 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 7 | Difficult to perform | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 7 | Very difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 7 | Difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 7 | Easy to perform | 8 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 7 | Very easy to perform | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 7 | Nor easy or difficult to perform | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 7 | Very difficult to perform | 0 Participants |
Secondary
Usability Questionnaire - Question 8
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options: * Yes * No
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 8 | No | 8 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 8 | Yes | 4 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 8 | Yes | 3 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 8 | No | 9 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 8 | No | 8 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 8 | Yes | 4 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 8 | No | 8 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 8 | Yes | 4 Participants |
Secondary
Usability Questionnaire - Question 9
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something: Response options: * One occasion * Several occasions * Most occasions * All occasions
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 9 | All occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 9 | Several occasions | 3 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 9 | Missing | 8 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 9 | Most occasions | 0 Participants |
| Single Application of Phenethylamines (D1) | Usability Questionnaire - Question 9 | One occasion | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 9 | Most occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 9 | All occasions | 0 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 9 | Missing | 9 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 9 | Several occasions | 1 Participants |
| Single Application of Benzodiazepines (D2) | Usability Questionnaire - Question 9 | One occasion | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 9 | Most occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 9 | One occasion | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 9 | Several occasions | 2 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 9 | All occasions | 0 Participants |
| Single Application of Cannabinoids (D3) | Usability Questionnaire - Question 9 | Missing | 8 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 9 | All occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 9 | Several occasions | 3 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 9 | One occasion | 1 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 9 | Most occasions | 0 Participants |
| Single Application of Opioids (D4) | Usability Questionnaire - Question 9 | Missing | 8 Participants |
Secondary
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an Attempt, and the successful transformation is denoted a Successful attempt.
Time frame: Day 7 +/- 2 days (Visit 2)
Population: FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 294 Successful attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 281 Successful attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Redness (RED) | 314 Successful attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Tremor (TR) | 295 Successful attempts |
| Single Application of Phenethylamines (D1) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Non-convergence (NC) | 296 Successful attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Tremor (TR) | 282 Successful attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 303 Successful attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Redness (RED) | 317 Successful attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 241 Successful attempts |
| Single Application of Benzodiazepines (D2) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Non-convergence (NC) | 282 Successful attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Tremor (TR) | 319 Successful attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Non-convergence (NC) | 318 Successful attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 305 Successful attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 309 Successful attempts |
| Single Application of Cannabinoids (D3) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Redness (RED) | 312 Successful attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Pupillary light reflex (PLR) | 317 Successful attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Horizontal nystagmus (NY) | 281 Successful attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Non-convergence (NC) | 297 Successful attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Tremor (TR) | 295 Successful attempts |
| Single Application of Opioids (D4) | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | Successful attempts - Redness (RED) | 325 Successful attempts |