Phase 3
N=18
Buprenorphine Group Medical Visits in Primary Care
Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02526212 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Opioid Abstinence at 8 Weeks — 0; 1 Participants — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- G-BMT (Behavioral); Treatment as usual (Behavioral); Buprenorphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Opioid Abstinence at 8 Weeks |
0; 1 | 0.44 |
| SECONDARY Number of Participants Who Were Retained in Buprenorphine Treatment at 3 Months and 6 Months |
8; 7; 8; 6 | — |
| SECONDARY Number of Participants Who Reported Sharing Injection Equipment at 8 Weeks |
0; 0 | — |
| SECONDARY Acceptability (Scale) |
4.6; 4.8 | 0.20 |
| SECONDARY Feasibility (Percentage of Visits Attended) |
69; 71 | — |
Summary
The primary goal of this research is to improve the effectiveness of buprenorphine maintenance treatment (BMT) within primary care.
Investigators propose that providing BMT as part of a group medical visit (instead of an individual visit) will improve treatment outcomes for patients with persistent opioid abuse, because members become accountable to the group, are exposed to beneficial habits of others (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly with medical management
Eligibility Criteria
Inclusion Criteria
- Currently receiving BMT at Montefiore community health center (CHC).
- Received BMT for 12 or more weeks.
- Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent test or in 50% or more of collected tests in the previous 6 months.)
- Fluent in English of Spanish
Exclusion Criteria
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02526212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.