Back to resultsUsability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suboxone Sublingual Film
Zubsolv sublingual tablets
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders
Eligibility Criteria
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.
Sites / Locations
- Hill Top Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Suboxone sublingual film 8/2
Zubsolv sublingual tablets 5.7/1.4
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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?
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?
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02038790
Brief Title
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indivior Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suboxone sublingual film 8/2
Arm Type
Experimental
Arm Description
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.
Arm Title
Zubsolv sublingual tablets 5.7/1.4
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Suboxone Sublingual Film
Other Intervention Name(s)
buprenorphine, naloxone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Zubsolv sublingual tablets
Other Intervention Name(s)
buprenorphine, naloxone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Intervention Preference As Assessed by Participants
Description
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
Secondary Outcome Measure Information:
Title
Participant Preference With Regard to Overall Taste of Interventions
Description
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
Title
Participant Assessments With Regard to Ease of Dissolution of Interventions
Description
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
Title
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Description
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
Title
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Description
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
Title
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Description
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
Title
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Description
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
Title
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Description
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time Frame
Days 0-1
Title
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Description
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time Frame
Days 0-1
Title
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'
Description
Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.
Time Frame
Days 0-1
Title
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
Description
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
Title
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Description
Choices to the question above are:
Crush and snort
Liquefy and inject
Not able to abuse this formulation
Time Frame
Days 0-1
Title
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.....
Description
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
Title
Dissolution Time of Intervention as Recorded by a Trained Observer
Description
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
Title
Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Murray, MD
Organizational Affiliation
Hill Top Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hill Top Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33714
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
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