Clinical trial NCT00637000
Conditions: Opioid-related Disorders
Keywords: Opioid dependence Opioid withdrawal symptoms
Sponsor: Indivior Inc.
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Detailed description:
Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study.

The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product:

* Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
* Improvement in subject convenience and compliance by ensuring rapid disintegration.
* Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
* Provision of a unit dose product format for hospital and institutional use.
* Decreased product damage during shipping as compared to Subutex and Suboxone tablets.

Arms: arm 1: Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.

Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours. arm 2: Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.

Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.
Interventions: intervention 1: Buprenorphine soluble film intervention 2: Buprenorphine/naloxone film strip intervention 3: Placebo
Intervention descriptions: intervention 1: Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment. intervention 2: Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment. intervention 3: Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

Protocol documents: