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NCT03232346 · ClinicalTrials.gov registry record · Phase 3
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
A Phase 3 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT03232346 is a Phase 3 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 11 participants.
The verdict
NCT03232346, a Phase 3 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DRUG Buprenorphine
- DRUG Vivitrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03232346
The ClinicalTrials.gov registry entry for NCT03232346 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine is the first listed.
NCT03232346 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03232346 about?
NCT03232346 is a clinical study titled "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 opioi...
What is the current status of trial NCT03232346?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2017-08-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03232346?
The interventions under investigation include: Buprenorphine (DRUG), Vivitrol (DRUG).
Who is sponsoring clinical trial NCT03232346?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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