At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 177 enrolled
Drug / intervention
sublingual buprenorphine tablets +3 moredrug
Likely dose
Not stated in 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, Double-Blind, Double-Dummy, Active-Controlled Multicenter Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily Maintenance Dose of 8 mg or Less of Sublingual Buprenorphine or Buprenorphine/Naloxone to Four Probuphine® Subdermal Implants
In Brief
A Phase 3 clinical trial evaluating sublingual buprenorphine tablets, Buprenorphine implant, and 2 other interventions for Opioid Dependence. Completed, enrolled 177 participants.
Detailed Summary
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN. The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedJul 3, 2014
Enrollment StartJul 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.0 years ago
Interventions
sublingual buprenorphine tabletsdrug
Buprenorphine implantdrug
placebo implantsdrug
sublingual placebo tabletsdrug