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Bupropion and Naltrexone in Methamphetamine Use Disorder.

Madhukar H Trivedi1, Robrina Walker1, Walter Ling1

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The New England Journal of Medicine
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PubMed
Summary
This summary is machine-generated.

Extended-release injectable naltrexone plus oral extended-release bupropion showed a modest increase in treatment response for methamphetamine use disorder compared to placebo over 12 weeks.

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Area of Science:

  • Addiction Medicine
  • Pharmacology
  • Clinical Trials

Background:

  • Methamphetamine use disorder (MUD) treatment efficacy remains a significant public health concern.
  • Limited research exists on combination therapies for MUD, specifically naltrexone plus bupropion.

Purpose of the Study:

  • To evaluate the efficacy and safety of extended-release injectable naltrexone plus oral extended-release bupropion for treating moderate to severe MUD.
  • To assess the treatment effect using a sequential parallel comparison design in a multisite trial.

Main Methods:

  • A double-blind, placebo-controlled, two-stage trial involving 403 participants in stage 1 and 225 in stage 2.
  • Participants received either naltrexone-bupropion or placebo, with response defined as at least three methamphetamine-negative urine samples out of four.
  • Weighted average response across both stages was calculated to determine the overall treatment effect.

Main Results:

  • The weighted average response was 13.6% for naltrexone-bupropion versus 2.5% for placebo, an 11.1 percentage point difference (P<0.001).
  • Adverse events included gastrointestinal issues, tremor, and anorexia; 3.6% of participants on naltrexone-bupropion experienced serious adverse events.

Conclusions:

  • Extended-release injectable naltrexone plus oral extended-release bupropion demonstrated a statistically significant but low response rate in adults with MUD compared to placebo.
  • The combination therapy showed a higher response rate, suggesting potential utility, though further research may be warranted.