Drug Abuse
Conditions
Brief summary
This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.
Detailed description
This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.
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
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The investigation aims to enroll up to 30 SUD subjects. 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. It is based on available subjects from the clinic.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Male and female * A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months * SUD in accordanve with DSM-5 criteria according to investigator/designee judgement * Age 18 and above * Negative urine pregnancy test for all fertile women * 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 * Any ECG dangerous arrythmia according to the investigator or designee 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 * Not able to read or understand the local language * Any planned travel or treatment which will make it impossible to participate according to the investigator or designee * 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 enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Questionnaire - Question 18. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment? Response options: * Very likely * Likely * Neither likely nor unlikely * Unlikely * Very unlikely |
| Usability Questionnaire - Question 14. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs? Response options: * Yes * No * Partly |
| Usability Questionnaire - Question 16. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 16. Was the study subject able to perform the test after receiving additional support? Response options: * Yes * No * Partly |
| Usability Questionnaire - Question 1. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 1. Please evaluate the study subject's ability to use the mobile phone? Response options: * Good * Manageable * Less good |
| Usability Questionnaire - Question 2 | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs? Response options: * Very good * Good * Either good or bad * Difficult * Very difficult |
| Usability Questionnaire - Question 17. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 17. How many efforts did it take the study subject to perform test with Previct Drugs? Response options: * 1-2 times * 3-4 times * More than 4 times |
| Usability Questionnaire - Question 4 | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 4. How did the study subject experience to put him/herself in the right position to be able to start a test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 6 | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 6. How would you evaluate the study subject's ability to perform a Cross-eyes test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 8 | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 8. How would you evaluate the study subject's ability to perform a Nystagmus test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 10 | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 10. How would you evaluate the study subject's ability to perform a Contraction Test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult |
| Usability Questionnaire - Question 12. | Day 0 (Visit 1) | Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 12. How did the study subject experience keeping the phone still during the test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Up to 4 weeks post baseline | The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types. |
| Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Up to 4 weeks post baseline | The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Confirmed SUD Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD). | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Subjects With Confirmed SUD | — |
|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 11.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 1. 2-3 times per week | 2 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 1. 2-4 times per month | 1 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 1. 4 times per week or more often | 21 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 1. Never | 0 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 1. Once a month or less often | 0 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 2. 2-3 times per week | 2 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 2. 2-4 times per month | 5 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 2. 4 times per week or more often | 12 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 2. Never | 4 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 2. Once a month or less often | 1 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 3. 0 | 0 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 3. 1-2 times | 3 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 3. 3-4 times | 11 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 3. 5-6 times | 7 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 3. 7 or more | 3 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 4. Alcohol | 8 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 4. Amphetamine, cocaine, ectasy | 18 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 4. BZ/Sleeping pills than alcohol? | 10 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 4. Hashish, cannabis | 9 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 4. Morphone, heroine, buprenorphine, fentanyl, codeine, tramadol | 13 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 4. Other | 2 Participants consuming the listed drug | — |
| Timeline follow-back for drugs and alcohol. Question 5. Affected | 1 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 5. Little affected | 18 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 5. Not affected | 5 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 5. Very affected | 0 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 6. As much as usual | 13 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 6. Less than usual | 7 Participants | — |
| Timeline follow-back for drugs and alcohol. Question 6. More than usual | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Usability Questionnaire - Question 1.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 1. Please evaluate the study subject's ability to use the mobile phone? Response options: * Good * Manageable * Less good
Time frame: Day 0 (Visit 1)
Population: Full analysis set (FAS)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 1. | Good | 16 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 1. | Manageble | 7 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 1. | Less good | 1 Participants |
Primary
Usability Questionnaire - Question 10
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 10. How would you evaluate the study subject's ability to perform a Contraction Test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS. Analysis data missing for one subject.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 10 | Very easy | 5 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 10 | Easy | 8 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 10 | Either easy or difficult | 2 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 10 | Difficult | 5 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 10 | Very difficult | 3 Participants |
Primary
Usability Questionnaire - Question 12.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 12. How did the study subject experience keeping the phone still during the test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS. Analysis data missing for one subject.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 12. | Very easy | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 12. | Easy | 15 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 12. | Either easy or difficult | 2 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 12. | Difficult | 2 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 12. | Very difficult | 1 Participants |
Primary
Usability Questionnaire - Question 14.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs? Response options: * Yes * No * Partly
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 14. | Yes | 10 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 14. | No | 14 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 14. | Partly | 0 Participants |
Primary
Usability Questionnaire - Question 16.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 16. Was the study subject able to perform the test after receiving additional support? Response options: * Yes * No * Partly
Time frame: Day 0 (Visit 1)
Population: FAS, the 10 subjects answering yes to usability question 14 (secondary endpoint 8)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 16. | No | 1 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 16. | Yes | 8 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 16. | Partly | 1 Participants |
Primary
Usability Questionnaire - Question 17.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 17. How many efforts did it take the study subject to perform test with Previct Drugs? Response options: * 1-2 times * 3-4 times * More than 4 times
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 17. | 1-2 times | 19 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 17. | 3-4 times | 4 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 17. | More than 4 times | 1 Participants |
Primary
Usability Questionnaire - Question 18.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment? Response options: * Very likely * Likely * Neither likely nor unlikely * Unlikely * Very unlikely
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 18. | Likely | 8 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 18. | Very likely | 8 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 18. | Neither likely nor unlikely | 4 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 18. | Unlikely | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 18. | Very unlikely | 1 Participants |
Primary
Usability Questionnaire - Question 2
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs? Response options: * Very good * Good * Either good or bad * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 2 | Very good | 5 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 2 | Good | 11 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 2 | Either good or bad | 6 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 2 | Difficult | 2 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 2 | Very difficult | 0 Participants |
Primary
Usability Questionnaire - Question 4
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 4. How did the study subject experience to put him/herself in the right position to be able to start a test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 4 | Very easy | 2 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 4 | Easy | 12 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 4 | Either easy or difficult | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 4 | Difficult | 4 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 4 | Very difficult | 3 Participants |
Primary
Usability Questionnaire - Question 6
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 6. How would you evaluate the study subject's ability to perform a Cross-eyes test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 6 | Very easy | 4 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 6 | Easy | 9 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 6 | Either easy or difficult | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 6 | Difficult | 6 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 6 | Very difficult | 2 Participants |
Primary
Usability Questionnaire - Question 8
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 8. How would you evaluate the study subject's ability to perform a Nystagmus test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Time frame: Day 0 (Visit 1)
Population: FAS. Analysis data missing for one subject.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Usability Questionnaire - Question 8 | Very easy | 10 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 8 | Easy | 7 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 8 | Either easy or difficult | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 8 | Difficult | 3 Participants |
| Subjects With Confirmed SUD | Usability Questionnaire - Question 8 | Very difficult | 0 Participants |
Secondary
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.
The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.
Time frame: Up to 4 weeks post baseline
Population: All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Successful tries - Non-convergence (NC) | 40 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Successful tries - Horizontal nystagmus (NY) | 23 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Successful tries - Tremor (TR) | 39 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Successful tries - Pupillary light reflex (PLR) | 79 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder. | Successful tries - Redness (RED) | 84 Number of tries |
Secondary
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.
The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.
Time frame: Up to 4 weeks post baseline
Population: All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Successful tries - Non-convergence (NC) | 40 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Successful tries - Horizontal nystagmus (NY) | 23 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Successful tries - Tremor (TR) | 39 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Successful tries - Pupillary light reflex (PLR) | 79 Number of tries |
| Subjects With Confirmed SUD | Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder. | Successful tries - Redness (RED) | 84 Number of tries |