s CTN Dissemination Library: Protocol CTN-0051 - Extended-Release Naltrexone


Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)

John Rotrosen, MD
Lead Investigator

New York University School of Medicine

This study will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®) versus buprenorphine-naloxone (BUP-NX, Suboxone®) as pharmacotherapeutic aids to recovery amongst treatment-seeking participants who have completed detoxification and achieved short term abstinence. The primary objective is to compare the effectiveness of XR-NTX versus BUP-NX in promoting the joint outcome of sustained retention in treatment and abstinence after an index admission for opioid dependence. A rescue protocol will enable the study to address additional questions regarding the sequencing of treatments.


Participants randomized to XR-NTX had a substantial induction hurdle: fewer successfully initiated XR-NTX than BUP-NX, resulting in a higher rate of 24-week relapse events for the XR-NTX group. Among participants successfully inducted to treatment, however, 24-week relapse events were similar across study groups. Self-reported opioid craving was initially less with XR-NTX than with BUP-NX (p=0.0012), then converged by week 24 (p=0.20). With the exception of mild-to-moderate XR-NTX injection site reactions, treatment-emergent adverse events including overdose did not differ between treatment groups.

In this population, it is more difficult to initiate patients to XR-NTX than to BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective.

Primary Outcomes Article: Lee JD, et al. Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial. The Lancet 2018;391(10118):309-318. [get article]



Publications about CTN-0051

ClinicalTrials.gov (NCT02032433)

NIDA protocol page

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 11/2016 -- http://ctndisseminationlibrary.org/protocols/ctn0051.htm