At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 228 enrolled
Drug / intervention
CAM2038 q1w or q4w exposure to SL BPN/NX +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CAM2038 q1w or q4w exposure to SL BPN/NX and CAM2038 q1w or q4w new to BPN treatment for Opioid Use Disorder. Completed, enrolled 228 participants across 32 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesAustralia, Denmark, Germany, Hungary, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedFeb 2016
Primary CompletionMay 2017
TodayJul 2026
First PostedFeb 3, 2016
Enrollment StartNov 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.4 years ago
Interventions
CAM2038 q1w or q4w exposure to SL BPN/NXdrug
CAM2038 q1w or q4w new to BPN treatmentdrug