Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Status:
Completed
Trial end date:
2017-01-31
Target enrollment:
Participant gender:
Summary
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone
(XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention
of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high
affinity partial agonist indicated for maintenance treatment of opioid dependence, as
pharmacotherapeutic aids to recovery.
The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment
programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or
BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72
hours after their last opioid).
The primary goal of the study is to estimate the difference, if one exists, between XR-NTX
and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence)
during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus
BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore
demographic and, clinical, and genetic predictors of successful treatment and moderators of
differential effectiveness (i.e., what variables may help clinicians choose which of these
treatments is best for a given patient).), and (3) collect a limited dataset to permit
analyses of economic costs and benefits of the two treatments.
Phase:
Phase 4
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health
Collaborators:
National Institute on Drug Abuse (NIDA) The Emmes Company, LLC The EMMES Corporation
Treatments:
Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone Naltrexone