Opioid Dependence
Conditions
Keywords
opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders
Brief summary
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.
Interventions
A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.
DRUGZubsolv sublingual tablets
A single Zubsolv sublingual tablet containing 5.7mg buprenorphine and 1.4mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.
Sponsors
Indivior Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* currently on a single daily dose of 8/2 of Suboxone or generic equivalent, or 5.7/1.4 mg Zubsolv for treatment of opioid dependence that has been medically confirmed. * in good general health with no specific contraindication for treatment with buprenorphine or naloxone. * the ability to understand, sign and date written consent and Health Information Portability and Accountability Act (HIPAA) authorization forms, which must be obtained prior to any study related procedures being completed. * Female subjects must be postmenopausal for at least 2 years, surgically sterile (i.e. tubal ligation, hysterectomy, or bilateral ovariectomy), or practicing an effective method of contraception during the study with one of the following methods: oral contraception, intrauterine device (IUD), abstinence, contraceptive injections, conscientious use of a diaphragm or condoms and spermicidal foam, systemic (implant) contraception or partner has had a vasectomy.
Exclusion criteria
* Subject is taking other opioids (other than buprenorphine/naloxone) that may interfere with the study evaluations or compromise the safety of the subject. * Subject is not able to read or have other impairments that may prevent completion of questionnaires or other study evaluations * Subject has open sores present in the oral cavity. * Subject has participated in any previous clinical testing involving investigational drug within the 4 weeks prior to study start. * Subject is pregnant, lactating or planning a pregnancy * Subject is currently participating in any other type of clinical testing. * Subject has a medical condition that in the Investigator's opinion could affect the taste assessments required by the study * Subject is judged by the Investigator after reviewing medical history to be unsuitable for any other reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Intervention Preference As Assessed by Participants | Day 1 | At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessments With Regard to Ease of Dissolution of Interventions | Day 1 | At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth? |
| Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? | Days 0-1 | Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. |
| Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? | Days 0-1 | Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. |
| Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? | Days 0-1 | Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. |
| Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? | Days 0-1 | Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1. |
| Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | Days 0-1 | Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme. |
| Participant Preference With Regard to Overall Taste of Interventions | Day 1 | At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste? |
| Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | Days 0-1 | Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high. |
| Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | Days 0-1 | Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse. |
| Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Days 0-1 | Choices to the question above are: * Crush and snort * Liquefy and inject * Not able to abuse this formulation |
| Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Days 0-1 | Choices to the question above are: * More effective as a treatment for opioid dependence * Equally effective as a treatment for opioid dependence * Less effective as a treatment for opioid dependence * The same medication that I normally use |
| Dissolution Time of Intervention as Recorded by a Trained Observer | Days 0-1 | The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site. |
| Change From Baseline in Subject Opiate Withdrawal Scale (SOWS) | Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose) | Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment. SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format. |
| Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | Days 0-1 | Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme. |
Countries
United States
Participant flow
Pre-assignment details
Thirty nine (39) subjects were screened and thirty three (33) subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Day 0 - First Treatment | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized White | 33 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 3 / 32 | 13 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Overall Intervention Preference As Assessed by Participants
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?
Time frame: Day 1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Overall Intervention Preference As Assessed by Participants | Suboxone | 54.84 percentage of participants |
| All Participants | Overall Intervention Preference As Assessed by Participants | Zubsolv | 45.16 percentage of participants |
p-value: >0.5Chi-squared
Secondary
Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment. SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format.
Time frame: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)
Population: Per protocol set.
Secondary
Dissolution Time of Intervention as Recorded by a Trained Observer
The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Dissolution Time of Intervention as Recorded by a Trained Observer | 6.59 minutes | Standard Deviation 5.28 |
| Zubsolv Sublingual Tablets 5.7/1.4 | Dissolution Time of Intervention as Recorded by a Trained Observer | 2.98 minutes | Standard Deviation 2.48 |
Secondary
Participant Assessments With Regard to Ease of Dissolution of Interventions
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?
Time frame: Day 1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Participant Assessments With Regard to Ease of Dissolution of Interventions | Suboxone | 19.35 percentage of participants |
| All Participants | Participant Assessments With Regard to Ease of Dissolution of Interventions | Zubsolv | 80.65 percentage of participants |
p-value: 0.0006Chi-squared
Secondary
Participant Preference With Regard to Overall Taste of Interventions
At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?
Time frame: Day 1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Participant Preference With Regard to Overall Taste of Interventions | Suboxone | 29.03 percentage of participants |
| All Participants | Participant Preference With Regard to Overall Taste of Interventions | Zubsolv | 70.97 percentage of participants |
p-value: 0.0196Chi-squared
Secondary
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? | Favorable response | 54.84 percentage of participants |
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? | Unfavorable response | 45.16 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? | Favorable response | 77.42 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth? | Unfavorable response | 22.58 percentage of participants |
p-value: 0.0603Chi-squared
Secondary
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? | Favorable response | 54.84 percentage of participants |
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? | Unfavorable response | 45.16 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? | Favorable response | 96.77 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth? | Unfavorable response | 3.23 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? | Favorable response | 61.29 percentage of participants |
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? | Unfavorable response | 38.71 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? | Favorable response | 51.61 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package? | Unfavorable response | 48.39 percentage of participants |
p-value: 0.4422Chi-squared
Secondary
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? | Favorable response | 100 percentage of participants |
| All Participants | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? | Unfavorable response | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? | Favorable response | 90.32 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow? | Unfavorable response | 9.68 percentage of participants |
p-value: 0.2377Chi-squared
Secondary
Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
Choices to the question above are: * More effective as a treatment for opioid dependence * Equally effective as a treatment for opioid dependence * Less effective as a treatment for opioid dependence * The same medication that I normally use
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | More effective | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Equally effective | 29.03 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Less effective | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Same medication I normally use | 67.74 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Same medication I normally use | 16.13 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | More effective | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Less effective | 32.26 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was..... | Equally effective | 51.61 percentage of participants |
Secondary
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 0 (none) | 67.74 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 1 | 19.35 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 2 | 6.45 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 3 | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 4 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 5 | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 6 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 7 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 8 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 9 (extreme) | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 7 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 0 (none) | 58.06 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 5 | 3.23 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 1 | 19.35 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 9 (extreme) | 3.23 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 2 | 16.13 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 6 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 3 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 8 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging? | 4 | 0 percentage of participants |
Secondary
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 5 | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 0 (none) | 70.97 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 6 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 3 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 7 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 1 | 22.58 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 8 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 4 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 9 (extreme) | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 2 | 3.23 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 9 (extreme) | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 0 (none) | 70.97 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 2 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 3 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 4 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 5 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 6 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 7 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 8 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters? | 1 | 29.03 percentage of participants |
Secondary
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Choices to the question above are: * Crush and snort * Liquefy and inject * Not able to abuse this formulation
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Crush and snort | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Liquefy and inject | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Not able to abuse this formulation | 100 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Crush and snort | 25.81 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Liquefy and inject | 3.23 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to...... | Not able to abuse this formulation | 70.97 percentage of participants |
Secondary
Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 4 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 0 (no high) | 70.97 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 5 | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 2 | 9.68 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 6 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 9 (extremely strong high) | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 7 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 3 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 8 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 1 | 16.13 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 9 (extremely strong high) | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 0 (no high) | 61.29 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 1 | 32.26 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 2 | 6.45 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 3 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 4 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 5 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 6 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 7 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High' | 8 | 0 percentage of participants |
Secondary
Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.
Time frame: Days 0-1
Population: The per-protocol population included participants who did not miss any visit and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 0 (no high) | 70.97 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 1 | 16.13 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 2 | 9.68 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 3 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 4 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 5 | 3.23 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 6 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 7 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 8 | 0 percentage of participants |
| All Participants | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 9 (extremely strong high) | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 7 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 0 (no high) | 61.29 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 5 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 1 | 35.48 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 9 (extremely strong high) | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 2 | 3.23 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 6 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 3 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 8 | 0 percentage of participants |
| Zubsolv Sublingual Tablets 5.7/1.4 | Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication | 4 | 0 percentage of participants |