A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
Status:
Completed
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
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.