At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Heroin +6 moredrug
Likely dose
Heroin 25 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.
Reinforcing Effects of Intravenous Buprenorphine Versus Buprenorphine/Naloxone in Buprenorphine-maintained Intravenous Drug Users (P05207)
In Brief
A Phase 3 clinical trial evaluating Heroin, Naloxone, and 5 other interventions for Opioid-related Disorders. Completed, enrolled 19 participants across 1 site.
Detailed Summary
The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-related Disorders
CountriesUnited States
CollaboratorsSchering-Plough
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedJul 2008
Primary CompletionAug 2008
TodayJul 2026
First PostedJul 4, 2008
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.0 years ago
Interventions
Heroindrug
Heroin (25 mg)
Naloxonedrug
.4 mg
Low Bup Dosedrug
4 and 8 mg
High Bup Dosedrug
8mg and 16 mg
Low Bup/Nal Dosedrug
Buprenorphine/Naloxone 4/1 mg, 8/2 mg
High Bup/Nal Dosedrug
Buprenorphine/Naloxone 8/2 mg, 16/4 mg
Placebo (PCB)drug
Placebo control administration