| 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? | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| Suboxone | | | | Zubsolv | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | | >0.5000 | Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted. | | | | | 2-Sided | | | | | | | | Superiority or Other | | |
|
| 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? | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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? | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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
| The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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
| The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Number | | percentage of participants | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | The per-protocol population included participants who did not miss any visit and had no major protocol violations. | Posted | | Mean | Standard Deviation | minutes | | Days 0-1 | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |
| 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. | | Posted | | | | | | Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose) | | | | ID | Title | Description |
|---|
| OG000 | Suboxone Sublingual Film 8/2 | Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. | | OG001 | Zubsolv Sublingual Tablets 5.7/1.4 | Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. |
| |