At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 27 enrolled
Drug / intervention
Intranasal challenge drugdrug
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.
Reinforcing Effects of Intranasal Buprenorphine Versus Buprenorphine/Naloxone in Buprenorphine-maintained Intranasal Drug Users
In Brief
A Phase 3 clinical trial evaluating Intranasal challenge drug for Heroin Dependence. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. The investigators hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeroin Dependence
CountriesUnited States
CollaboratorsIndivior Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedJan 2013
Primary CompletionDec 2014
TodayJul 2026
First PostedJan 4, 2013
Enrollment StartMay 1, 2009
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 13.5 years ago
Interventions
Intranasal challenge drugdrug
Each of the experimental challenge drugs were administered intranasally to all participants in random order.