Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

Study Overview
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Brief Summary
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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.

Official Title
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A Single Center, Randomized, 2 Way Cross-Over, Phase 4 Study Comparing Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 Including Ease of Use, Taste Preference, Dissolution Time, Desire to Abuse, and Overall Acceptance In Buprenorphine/Naloxone Treated Opioid Dependent Population

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: Suboxone Sublingual Film
* Drug: Zubsolv sublingual tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suboxone sublingual film 8/2<br>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. | Drug: Suboxone Sublingual Film<br>* 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.<br>* Other names: naloxone;|
| Active Comparator: Zubsolv sublingual tablets 5.7/1.4<br>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. | Drug: Zubsolv sublingual tablets<br>* 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.<br>* Other names: naloxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | Day 1 | 
| 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? | Day 1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Days 0-1 | 
| 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 | Days 0-1 | 
| 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 | Days 0-1 | 
| 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. | Days 0-1 | 
| 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. | Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders