drugset / Trial / NCT05011266

Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

NCT05011266

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

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 5.7 mg Other
Subject Naloxone Small molecule 1.4 mg Other

Indications