Glenn-Milo Santos, Ph.D., M.P.H., Janet Ikeda, M.A., Phillip Coffin, M.D., M.I.A., John Walker, N.P., Tim Matheson, Ph.D.,Arsheen Ali, B.A., Matthew McLaughlin, A.B., Jennifer Jain, Ph.D., M.P.H., Justine Arenander, M.S.W., Eric Vittinghoff, Ph.D.,Steven Batki, M.D.

Objective: The authors sought to determine the efficacy of targeted naltrexone in sexual and gender minority men (SGM) who binge drink and have mild to moderate alcohol use disorder.

Methods: In a double-blind placebo-controlled trial, a total of 120 SGM who binge drink and have mild to moderate alcohol use disorder were randomized in a 1:1 ratio to receive targeted oral naltrexone (50 mg) or placebo with weekly counseling for 12 weeks.

The study’s primary endpoints were binge-drinking intensity, defined as 1) the number of drinks in thepast 30days; 2)any binge drinking in the past week; 3) number of binge-drinking days in the past week; and 4) number of drinking days in the past week. The study also measured changes in alcohol use with two alcohol biomarker measures: ethyl glucuronide in urine samples and phosphatidyl ethanol (PEth) in dried blood spot samples.

Results: Ninety-three percent completed the trial, with 85%of weekly follow-up visits completed. In intention-to-treat analyses, naltrexone was associated with a significantly reduced reported number of binge-drinking days (incidence rate ratio [IRR]50.74, 95% CI50.56, 0.98; number needed to treat [NNT] 52), weeks with any binge drinking (IRR50.83,95% CI50.72, 0.96; NNT57.4), number of drinks per month(IRR50.69, 95% CI50.52, 0.91; NNT55.7 for 10 drinks), and alcohol craving scores (coefficient529.25, 95% CI5217.20,21.31).

In as-treated analyses among those who took their medication on average at least 2.5 days per week (the median frequency in the study), naltrexone reduced any binge drinking (IRR50.84, 95% CI50.71, 0.99), number of binge-drinking days (IRR50.67, 95% CI50.47, 0.96), and PEthconcentrations (coefficient5255.47, 95% CI52110.75,20.20). At 6 months posttreatment, naltrexone had sustained effects in number of drinks per month (IRR50.69, 95% CI50.50, 0.97), number of binge-drinking days (IRR50.67, 95% CI50.47, 0.95),and any binge drinking in the past week (IRR50.79, 95%CI50.63, 0.99).

Conclusions: Targeted naltrexone significantly reduced drinking outcomes among SGM with mild to moderate alcohol use disorder during treatment, with sustained effects at6 months posttreatment. Naltrexone may be an important pharmacotherapy to address binge drinking in populations with mild to moderate alcohol use disorder.