drugset / Trial / NCT00684073

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

NCT00684073 ↗

Phase 4 Completed 60 enrolled Indivior Inc.
NaSingle-groupOpen-labelTreatment

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®.

Timeline

Start
2007-07
Primary completion
2007-12
Completion
2007-12

Outcome

Missed primary endpoint

registry analysis (unspecified test); Day 1 (Subutex®) vs Day 2 (Subutex®) vs Day 3 (Suboxone®) vs Day 4 (Suboxone®) vs Day 5 (Suboxone®); p = 0.130; Mean Difference (Net) 0.42; ANCOVA NCT00684073 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 0.5 mg —
Subject Naloxone Small molecule 2 mg —
Subject Naloxone Small molecule 4 mg —
Background Buprenorphine Other / unclassified 2 mg —
Background Buprenorphine Other / unclassified 8 mg —
Background Buprenorphine Other / unclassified 16 mg —