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Published on: January 22, 2016
Bupropion and Naltrexone in Methamphetamine Use Disorder
Madhukar H Trivedi1, Robrina Walker1, Walter Ling1
1From the Peter O'Donnell Jr. Brain Institute at the University of Texas Southwestern Medical Center (M.H.T.) and the University of Texas Southwestern Medical Center (R.W., A.C., T.C., M.K., K.S.-W., S.W.), Dallas, the University of Texas Health Science Center at Houston, Houston (J.S.), and Texas Tech University, Permian Basin, Odessa (A.J.R.); the University of California, Los Angeles, Los Angeles (W.L., S. Shoptaw); the Emmes Company, Rockville (G.S., A.W.), and the National Institute on Drug Abuse Center for the Clinical Trials Network (U.E.G., S. Sparenborg [retired]), Rockville - both in Maryland; the San Francisco Department of Public Health and the University of California, San Francisco, San Francisco (P.C.); CODA, Portland, OR (K.W.); Hennepin Healthcare, University of Minnesota, Minneapolis (G.B.); Medical University of South Carolina, Charleston (S.C.S.); Duke-National University of Singapore, Singapore (A.J.R.); Duke Medical School, Durham, NC (A.J.R.); and Columbia University, New York (E.V.N.).
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.
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.
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