NCT02672111

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Braeburn Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits) or individuals who are actively seeking BPN treatment but who have not yet begun a treatment regimen, may be eligible for the study. Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects will be initiated or transitioned to CAM2038 q1w or q4w as follows: Initiation of BPN treatment - initiate with CAM2038 q1w Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	CAM2038 q1w or q4w exposure to SL BPN/NX
DRUG	CAM2038 q1w or q4w new to BPN treatment

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-02-03
• Last updated: 2020-05-15
• Results posted: 2019-08-01

Locations

32 sites across 8 countries: United States, Australia, Denmark, Germany, Hungary, Sweden, Taiwan, United Kingdom