This study, CTN-0054, “Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder,” was the first investigation of the combination of extended-release bupropion and long-acting injectable naltrexone as a potential pharmacotherapy for methamphetamine use disorder utilizing a video-based strategy to improve and monitor medication adherence.
The study was a 2-stage, open-label pilot project conducted across 3 sites with 20 patients enrolled in stage 1 and 29 in stage 2.
Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP, Wellbutrin XL) were provided, along with a smartphone-assisted medication adherence platform in which participants were asked to video record themselves taking their doses on non-clinic days.
Participants attended clinic twice weekly for observed BRP dosing, urine drug screens, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9.
Analyses evaluated effects of XR-NTX + BRP to determine the number of “responders” according to a statistically predefined response criterion (6 of 8 methamphetamine-negative urine drug screens during the last 4 weeks of medication). The 2-stage design required that stage 1 yield 3 or more responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2).
Conclusions: The medication combination safely resulted in a clinically meaningful outcome, demonstrated by the proportion of participants who met ‘‘responder’’ criteria. These findings support the need for further study using an adequately powered, randomized, placebo-controlled design to evaluate the combination pharmacotherapy for methamphetamine use disorder. The 2-stage design could also be used to efficiently evaluate other interventions for stimulant use disorder and thus accelerate treatment development.
Find it in the CTN Dissemination Library: http://ctndisseminationlibrary.org/display/1201.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:
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).