Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

Phase 3 Completed 228 enrolled Braeburn Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

Timeline

Start: 2015-11
Primary completion: 2017-05
Completion: 2017-05

Publications

Frost M, Bailey GL, Lintzeris N, Strang J, Dunlop A, Nunes EV, Jansen JB, Frey LC, Weber B, Haber P, Oosman S, Kim S, Tiberg F. Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. Addiction. 2019 Aug;114(8):1416-1426. doi: 10.1111/add.14636. Epub 2019 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buprenorphine	Other / unclassified	8 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	16 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	24 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	32 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	64 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	96 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	128 mg	Subcutaneous
Subject	Buprenorphine	Other / unclassified	160 mg	Subcutaneous

Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

Summary

Timeline

Publications

Drugs

Indications