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Bupropion and Naltrexone in Methamphetamine Use Disorder.

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Date
2021-01
Authors
Trivedi, Madhukar H
Walker, Robrina
Ling, Walter
Dela Cruz, Adriane
Sharma, Gaurav
Carmody, Thomas
Ghitza, Udi E
Wahle, Aimee
Kim, Mora
Shores-Wilson, Kathy
Sparenborg, Steven
Coffin, Phillip
Schmitz, Joy
Wiest, Katharina
Bart, Gavin
Sonne, Susan C
Wakhlu, Sidarth
Rush, A John
Nunes, Edward V
Shoptaw, Steven
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Abstract
<h4>Background</h4>The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.<h4>Methods</h4>We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.<h4>Results</h4>A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.<h4>Conclusions</h4>Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).
Type
Journal article
Subject
Humans
Amphetamine-Related Disorders
Methamphetamine
Bupropion
Naltrexone
Narcotic Antagonists
Delayed-Action Preparations
Drug Therapy, Combination
Administration, Oral
Injections
Double-Blind Method
Adolescent
Adult
Aged
Middle Aged
Female
Male
Medication Adherence
Young Adult
Permalink
https://hdl.handle.net/10161/24797
Published Version (Please cite this version)
10.1056/nejmoa2020214
Publication Info
Trivedi, Madhukar H; Walker, Robrina; Ling, Walter; Dela Cruz, Adriane; Sharma, Gaurav; Carmody, Thomas; ... Shoptaw, Steven (2021). Bupropion and Naltrexone in Methamphetamine Use Disorder. The New England journal of medicine, 384(2). pp. 140-153. 10.1056/nejmoa2020214. Retrieved from https://hdl.handle.net/10161/24797.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Augustus John Rush

Adjunct Professor in the Department of Psychiatry and Behavioral Sciences
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