The aim of this 2-stage, 3-site study is to investigate the safety and effectiveness of depot naltrexone (XR-NTX; as Vivitrol®) plus extended-release bupropion (BRP; as Wellbutrin XL®) for methamphetamine use disorder. Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type). Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of depot naltrexone plus once-daily bupropion extended-release tablets for 8 weeks. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and follow-up visit during Week 9. If Stage 1 data document success in at least 3 “responder” study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of “responder” success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.
The primary objective of this single-arm, open-label pilot study was to evaluate the safety and preliminary efficacy of XR-NTX + BRP as a potential treatment for MA use disorder. Under the statistical analysis plan, study “success” required 9 or more responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study. Findings also support the general safety and tolerability of this medication combination in MA users, and had high rates of retention and medication adherence.
Primary Outcomes Article: Mooney LJ, et al. Utilizing a Two-Stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-Daily Bupropion as a Treatment for Methamphetamine Use Disorder. Journal of Addiction Medicine 2016 (in press). [get article]
- CTN-0068: Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
All Participating Nodes: