At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 428 enrolled
Drug / intervention
CAM2038 SC injection +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 Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder
In Brief
A Phase 3 clinical trial evaluating CAM2038 SC injection, SL BPN/NX tabs, and 2 other interventions for Opioid Use Disorders. Completed, enrolled 428 participants across 36 sites.
Detailed Summary
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedJan 2016
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedJan 11, 2016
Enrollment StartDec 1, 2015
Primary CompletionOct 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.5 years ago
Interventions
CAM2038 SC injectiondrug
SL BPN/NX tabsdrug
placebo SC injectionsdrug
SL placebo tabletsdrug