At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 241 enrolled
Drug / intervention
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 +1 moredrug
Likely dose
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
In Brief
A Phase 4 clinical trial evaluating Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 and Subutex, Buprenorphine Hydrochloride, SCH 28444 for Opiate Dependence and Drug Dependence. Completed, enrolled 241 participants.
Detailed Summary
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence, Drug Dependence
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2008
Enrollment StartMar 2008
Primary CompletionApr 2009
Study CompletionMay 2009
TodayJul 2026
First PostedJan 30, 2008
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.4 years ago
Interventions
Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484drug
Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days
Subutex, Buprenorphine Hydrochloride, SCH 28444drug
Subutex sublingual tablet 4-24 mg, daily for 28 days