NCT02651584

Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Braeburn Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Opioid Use Disorders

Interventions

Type	Name	Description
DRUG	CAM2038 SC injection
DRUG	SL BPN/NX tabs
DRUG	placebo SC injections
DRUG	SL placebo tablets

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2016-01-11
• Last updated: 2019-08-22
• Results posted: 2019-08-22

Locations

36 sites across 1 country: United States