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Randomized Controlled Trial
. 2024 Oct;119(10):1840-1845.
doi: 10.1111/add.16529. Epub 2024 Jun 10.

Extended observation of reduced methamphetamine use with combined naltrexone plus bupropion in the ADAPT-2 trial

Michael J Li  1   2 , Brendon Chau  3 , Thomas Belin  3 , Thomas Carmody  4   5 , Manish K Jha  4   6 , Elise N Marino  4 , Madhukar Trivedi  4   6 , Steven J Shoptaw  1   2   7
Affiliations
Randomized Controlled Trial

Extended observation of reduced methamphetamine use with combined naltrexone plus bupropion in the ADAPT-2 trial

Michael J Li et al. Addiction. 2024 Oct.

Abstract

Background and aims: A 12-week placebo-controlled, sequential parallel Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT-2) trial evaluated the effects of extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN) on methamphetamine (MA) use over two stages. This study reports on the previously unpublished stage 2 MA use in participants randomized at stage 1 to receive NTX + BUPN through both stages compared with those assigned to placebo.

Design: This is a secondary analysis of the US National Institute on Drug Abuse (NIDA) ADAPT-2 network trial.

Setting: The parent ADAPT-2 trial was carried out across multiple NIDA Clinical Trials Network (CTN) sites in the United States.

Participants: This analysis includes 403 people with MA use disorder who participated in the ADAPT-2 CTN trial.

Intervention and comparator: NTX + BUPN was compared with placebo over the course of the trial.

Measurement: MA use was measured by urine drug screens conducted twice weekly for 12 weeks, then once in week 13 and once in week 16 post-treatment follow-up.

Findings: Participants on NTX + BUPN in stage 1 showed an additional 9.2% increase [95% confidence interval (CI), 0.09%-17.9%, P = 0.038] during stage 2 in their probability of testing negative for MA, with a total increase of 27.1% (95% CI, 13.2%-41.1%, P < 0.001) over the full 12 weeks of treatment. In contrast, participants on placebo in both stages increased in probability of testing MA-negative by a total of 11.4% (95% CI, 4.1%-18.6%, P = 0.002) over all 12 weeks. The 12-week increase among participants on NTX + BUPN was significantly greater-by 15.8% (95% CI, 4.5%-27.0%, P = 0.006)-than the increase among those on placebo.

Conclusion: For people with methamphetamine (MA) use disorder receiving treatment with extended-release injectable naltrexone plus extended-release oral bupropion (NTX + BUPN), continued treatment with NTX + BUPN after 6 weeks is associated with additional reductions in MA use up to 12 weeks.

Keywords: abstinence, bupropion, clinical trial, methamphetamine, naltrexone, reduction.

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Conflict of interest statement

Declaration of Interests

Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with the U.S. National Institute on Drug Abuse.

Figures

Figure 1.
Figure 1.
Marginal expected mean percentage (with pointwise 95% confidence bands) of methamphetamine-negative urine tests over 12 weeks while on naltrexone plus bupropion versus placebo, and during posttreatment follow-up from week 13 to 16.
See this image and copyright information in PMC

References

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