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

Condition(s) targeted: Opioid Dependence

Intervention: Suboxone Sublingual Film (Drug); Zubsolv sublingual tablets (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Reckitt Benckiser Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
John Murray, MD, Principal Investigator, Affiliation: Hill Top Research

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: 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Intervention Preference As Recorded by Participants

Secondary outcome:

Taste preference including taste acceptability as Assessed by Participants

Participant Desire to abuse as Assessed by Participants

Dissolution time of Intervention as Recorded by a Trained Observer

Overall acceptability of Intervention as Assessed by Participants

Ease-of-use As Assessed by Participants

Change from Baseline in Subject Opiate Withdrawal Scale (SOWS)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Hill Top Research, St Petersburg, Florida 33714, United States

Starting date: November 2013
Last updated: January 15, 2014