NCT03232346

A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Vivitrol	Oral naltrexone induction procedure followed by Vivitrol
DRUG	Buprenorphine	5-week buprenorphine taper

Timeline

• Start date: 2017-08-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-07-28
• Last updated: 2022-11-07
• Results posted: 2022-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study