This NIDA Clinical Trials Network study, CTN-0051, aimed to fill that research gap by comparing opioid relapse-free survival between XR-NTX and BUP-NX. It was a 24-week, open-label, randomized controlled, comparative effectiveness trial held in 8 U.S. community-based inpatient services, with outpatient follow-up for participants, all of whom were users or heroin or prescription-type opiates.
Half of the participants (283) were randomized to receive XR-NTX (Vivitrol), a monthly injection, with the other half (287) assigned to receive BUP-NX (Suboxone), which came as a film patients placed under their tongues (“sublingual”). Participants were followed for 24 weeks of outpatient treatment.
As expected, patients randomized to XR-NTX had a substantial induction hurdle: XR-NTX can trigger severe withdrawal in patients if they have not detoxed from opioids first, and detox can be extremely difficult for opioid users (treatment with Suboxone can be started sooner, while the patient is still experiencing some withdrawal). As a result, fewer participants successfully initiated treatment with XR-NTX (72%) than with BUP-NX (94%).
Among all participants who were randomly assigned (“intention-to-treat” population, n=570), 24-week relapse events were greater for XR-NTX (65%) than for BUP-NX (57%). However, most or all of this difference (89%) was due to patients in the XR-NTX group dropping out of detox before receiving the medication.
Of the 474 participants who did successfully begin treatment, however, researchers found that:
Conclusions: In this population of opioid users, it was more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.
For more on these important outcomes, check out these national news stories about the study:
New York Times, Washington Post, Wall Street Journal, and CNN.
Find it in the CTN Dissemination Library!
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. Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial. The Lancet 2017 (in press)