Opioid Use Disorders Clinical Trial
Official title:
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
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.
This is a 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. The
trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits),
and Follow-up.
Approximately 380 subjects (190 subjects per arm) will be randomized.
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