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

  • 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: http://ctndisseminationlibrary.org/display/1220.htm

Funding for this Addiction Science Made Easy project is provided by the Addiction Technology Transfer Center National Office, under the cooperative agreement from the Center for Substance Abuse Treatment of SAMHSA.

Articles were written based on the following published research:

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).