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X-BOT study to compare extended-release naltrexone to buprenorphine for opioid treatment

September 1, 2016
Lee, JD et al.
Lee JD, et al. NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study Design and Rationale.  Contemporary Clinical Trials 2016 (in press).
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  • For opioid-dependent patients in the U.S. and elsewhere, treatment typically involves detoxification and counseling-only aftercare.
  • Long-term abstinence is rarely achieved, with many patients relapsing and overdosing after detoxing.
  • Methadone, buprenorphine-naloxone (BUP-NX), and extended-release naltrexone (XR-NTX) have been demonstrated effective in preventing opioid relapse but are underutilized.

This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies.

The NIDA Clinical Trials Network (CTN) study CTN-0051 (X:BOT) is a comparative effectiveness study of treatment for 24 weeks with XR-NTX, an opioid antagonist, versus BUP-NX, a high affinity partial opioid agonist, for opioid dependent patients initiating treatment at 8 short-term residential (detoxification) units and continuing care as outpatients. Up to 600 participants are randomized (1:1) to XR-NTX or BUP-NX.

The primary outcome is time to opioid relapse (i.e., loss of persistent abstinence) across the 24-week treatment phase. Differences between arms in the distribution of time-to-relapse will be compared. Secondary outcomes include proportions retained in treatment; rates of opioid abstinence; adverse events; cigarette, alcohol, and other drug use and HIV risk behaviors; opioid cravings; quality of life; cognitive function; genetic moderators; and cost effectiveness.

Find it in the CTN Dissemination Library: