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A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at least 6 months of buprenorphine treatment and do not wish to remain in a long--term buprenorphine maintenance program will be recruited. The first phase includes a 4--week period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that patients are stable, compliant, and free from illicit opioids. Participants that meet the above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a gradual 5-week long taper. In both groups participants will receive weekly relapse prevention therapy and will be monitored for the duration of the trial, which is 25 weeks post randomization.
Details
| Lead sponsor | New York State Psychiatric Institute |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 11 |
| Start date | Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Jun 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Opioid-use Disorder
Interventions
- Vivitrol
- Buprenorphine
Countries
United States