Buprenorphine Group Medical Visits in Primary Care
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | January 1, 2017 |
| End Date: | May 2019 |
| Contact: | Whitney Y Colon, Bachelors |
| Email: | whcolon@montefiore.org |
| Phone: | 7189205682 |
Buprenorphine Group Medical Visits for Drug Users at Risk for HIV
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
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
Investigators have developed a preliminary model of BMT group medical visits, conducted focus
groups with BMT patients and providers, and will use this data to develop a manualized
group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled
trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy,
acceptability, and feasibility. Participants who have persistent opioid abuse while receiving
BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5
groups) or to intensify BMT (treatment as usual) with their individual primary care physician
(40 participants).
Hypothesis: In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs.
treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV
risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and
adherence to medical visits (feasibility).
groups with BMT patients and providers, and will use this data to develop a manualized
group-based BMT intervention (G-BMT). Investigators will then conduct a randomized controlled
trial (RCT) of the G-BMT intervention within primary care to preliminarily test its efficacy,
acceptability, and feasibility. Participants who have persistent opioid abuse while receiving
BMT in primary care will be randomized to the G-BMT intervention (40 participants in 5
groups) or to intensify BMT (treatment as usual) with their individual primary care physician
(40 participants).
Hypothesis: In a 16-week RCT of G-BMT, participants who receive the G-BMT intervention (vs.
treatment as usual) will have higher abstinence rates (primary outcome, efficacy), fewer HIV
risk behaviors (efficacy), and greater satisfaction with treatment (acceptability) and
adherence to medical visits (feasibility).
Inclusion Criteria:
1. Currently receiving BMT at Montefiore community health center (CHC).
2. Received BMT for 12 or more weeks.
3. 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.)
4. Fluent in English of Spanish
Exclusion Criteria:
1) Pregnancy
We found this trial at
1
site
Click here to add this to my saved trials
