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Naltrexone + buproprion potentially effective for methamphetamine disorder

September 1, 2016
Mooney, L.J., et al.
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).
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  • Rates of lifetime methamphetamine use peaked in 2006 in the United States, but it remains a significant public health problem.
  • Methamphetamine use is associated with medical, psychiatric, and socioeconomic consequences.
  • There are currently no approved medications to help reduce relapse from methamphetamine use, but both bupropion and naltrexone have shown preliminary clinical utility in reducing use.

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.

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