An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

NCT02672111 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Braeburn Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	228
Start date	2015-11
Completion	2017-05

Conditions

• Opioid Use Disorder

Interventions

• CAM2038 q1w or q4w exposure to SL BPN/NX
• CAM2038 q1w or q4w new to BPN treatment

Primary outcomes

• Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population — 12 months- 48 week
  Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population
• Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population — 12 months- 48 week
  Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population

Countries

United States, Australia, Denmark, Germany, Hungary, Sweden, Taiwan, United Kingdom