DESCRIPTION: The primary objective of this double-blind, placebo-controlled, adaptive, randomized clinical trial is to evaluate the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Secondary outcomes will assess the safety of naltrexone plus bupropion and determine the efficacy of the combination pharmacotherapy on other substance use outcomes, on depression symptom scores, and on quality of life ratings. 370 individuals with moderate or severe methamphetamine use disorder will be randomly assigned to the active medication combination arm or the matching placebo arm. Participants will have visits twice weekly during the 12 week medication phase and complete follow-up visits in weeks 13 and 16.
STATUS: This study has completed. Results can be found here
- Trivedi MH, Walker R, Ling W, Dela Cruz A, Sharma G, Carmody T, Ghitza UE, Wahle A, Kim M, Shores-Wilson K, Sparenborg S, Coffin P, Schmitz J, Wiest K, Bart G, Sonne SC, Wakhlu S, Rush AJ, Nunes EV, Shoptaw S. Bupropion and Naltrexone in Methamphetamine Use Disorder. N Engl J Med. 2021 Jan 14;384(2):140-153. PMID: 33497547; PMCID: PMC8111570.