drugset / Trial / NCT05011266
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
Phase 2/3
Recruiting
180 enrolled
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.
Timeline
- Start
- 2023-04-18
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 5.7 mg | Other |
| Subject | Naloxone | Small molecule | 1.4 mg | Other |