Overview

This trial is active, not recruiting.

Condition opioid dependence
Treatments suboxone sublingual film, zubsolv sublingual tablets
Phase phase 4
Sponsor Reckitt Benckiser Pharmaceuticals Inc.
Start date November 2013
End date January 2014
Trial size 33 participants
Trial identifier NCT02038790, RBP-OSZ1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
suboxone sublingual film buprenorphine
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.
(Active Comparator)
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.
zubsolv sublingual tablets buprenorphine
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 Outcomes

Measure
Overall Intervention Preference As Recorded by Participants
time frame: Day 0 (post treatment), Day 1

Secondary Outcomes

Measure
Taste preference including taste acceptability as Assessed by Participants
time frame: Days 0-1
Participant Desire to abuse as Assessed by Participants
time frame: Days 0-1
Dissolution time of Intervention as Recorded by a Trained Observer
time frame: Days 0-1
Overall acceptability of Intervention as Assessed by Participants
time frame: Days 0-1
Ease-of-use As Assessed by Participants
time frame: Days 0-1
Change from Baseline in Subject Opiate Withdrawal Scale (SOWS)
time frame: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator John Murray, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Reckitt Benckiser Pharmaceuticals Inc..