NCT00684073

Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

Evaluation of Preference for a Buprenorphine-based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphine/Naloxone Combination (Suboxone®), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

Conditions

• Opiate-related Disorders
• Opiate Dependence
• Drug Abuse

Interventions

Type	Name	Description
DRUG	buprenorphine	2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study
DRUG	buprenorphine/naloxone	2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-05-26
• Last updated: 2023-03-20
• Results posted: 2010-01-01