Baseline characteristics by randomization status in NIDA-CTN-0051, extended-release naltrexone vs. buprenorphine for opioid treatment (X-BOT).
NIDA-CTN-0051 is a multi-center, two-arm, 6-month (24-week), parallel-group, open-label randomized controlled trial to examine the comparative effectiveness and safety of extended-release naltrexone (XR-NTX) versus buprenorphine+naloxone (BUP-NX). 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. This poster reports on the study participant enrollment process for CTN-0051, from consent to the point of randomization, comparing randomized vs. not randomized participants for baseline demographics, motivations for participating in the study, and attitudes about study medication.
After analysis, the greatest difference between the two groups appeared to be the role of access to medication as a motivating factor (endorsed by 39% of the not randomized group vs. only 16% of the randomized group). After assessing the motivations and attitudes about treatment, it also appeared that the preference for BUP-NX was stronger than that for XR-NTX. However, motivations and attitudes toward treatment were not collected for all the not randomized participants (before they dropped out of the treatment setting or screening). Conclusions about motivations for the not randomized group may not be generalizable. Overall, the two groups were quite similar.
Related protocols: CTN-0051