Response was low but higher with naltrexone-bupropion than placebo during 12-week, two-stage trial<\/p>\n<\/h3>\n
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FRIDAY, Jan. 15, 2021 (HealthDay News) — For adults with methamphetamine use disorder, response is higher with receipt of extended-release injectable naltrexone plus oral extended-release bupropion versus placebo, according to a study published in the Jan. 14 issue of the New England Journal of Medicine<\/em>.<\/p>\n Madhukar H. Trivedi, M.D., from the University of Texas Southwestern Medical Center in Dallas, and colleagues conducted a multisite trial with use of a sequential parallel comparison design. Adults with moderate or severe methamphetamine use disorder were randomly assigned to receive either naltrexone-bupropion or matching injectable and oral placebo for six weeks. Those in the placebo group with no response in stage 1 were randomly reassigned to receive naltrexone-bupropion or placebo for an additional six weeks (stage 2). The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples.<\/p>\n Overall, 403 participants were enrolled in stage 1 and 225 were enrolled in stage 2. The researchers found that 16.5 percent of the naltrexone-bupropion group and 3.4 percent of the placebo group had a response in the first stage; 11.4 and 1.8 percent, respectively, had a response in the second stage. Across the two stages, the weighted average response was 13.6 and 2.5 percent for naltrexone-bupropion and placebo, respectively, for an overall treatment effect of 11.1 percentage points.<\/p>\n “Replication of our trial results in a more naturalistic effectiveness design could be a next step,” the authors write.<\/p>\n Several authors disclosed financial ties to pharmaceutical companies, including Alkermes, which provided Vivitrol and matching placebo free of charge for use in this trial.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n