Naltrexone significantly reduced binge drinking behavior among sexual and gender minority men (SGM) with mild to moderate alcohol use disorder (AUD), according to study results published in AJP in Advance.
Individuals (N=120) who were SGM, had AUD (ie, engaging in at least 1 binge-drinking episode per week for the past 3 months) and were interested in reducing their alcohol intake were recruited from the University of California, San Francisco. Participants were randomly assigned in a 1:1 ratio to receive either oral naltrexone 50 mg (n=60) or placebo (n=60) for 12 weeks. Self-reported alcohol measures and ethyl glucuronide (EtG) and phosphatidylethanol (PEth) levels were assessed through a 6-month follow-up.
Study participants’ median age was 37 (interquartile range [IQR], 30-45) years, 54% were White, 26% were positive for HIV infection, 13% had previously been hospitalized for alcohol problems, 19% had previously received alcohol treatment. Median visual analogue scale (VAS) alcohol craving score was 30 (IQR, 10-50) points.
Overall, 85% of participants attended all weekly follow-up visits, 93% were retained through the end of the study, and 84% attended the 6-month follow-up. Rates of retention and follow-up attendance did not differ between treatment groups. The reported adherence to naltrexone was 71.05% and the reported adherence to placebo was 76.19% (P =.17).
In the intention-to-treat analysis, naltrexone was assoicated with fewer binge-drinking days in the past 30 days (incidence rate ratio [IRR], 0.69; P =.01), any binge drinking in the past week (IRR, 0.83; P =.01), number of binge-drinking days in the past week (IRR, 0.74; P=.03), and alcohol VAS craving score (coefficient, -9.25; 95% CI, -17.20 to -1.31; P =.02) compared with placebo. Naltrexone did not have a significant effect on the number of drinking days in the past week (P =.80), EtG levels greaters than 100 ng/mL (P =.84), or PEth levels greater than 20 ng/mL (P =.33).
Naltrexone did not have an effect on any sexual behavior outcomes.
Two serious adverse events were reported during the study, but neither were deemed to be related with the intervention medication. Naltrexone recipients reported more nausea than placebo recipients (P =.02). Other common adverse effects included hyperglycemia, headache, increased alanine transaminase, and increased aspartate transaminase.
More of the placebo recipients correctly guessed they were given placebo (59%) compared with the naltrexone recipients who correctly guessed they were given naltrexone (39%; P =.054).
Most participants were satisfied or highly satisfied with their decision to participate in the study (84%).
The study is limited by the reliance on self-reported alcohol outcomes.
Study authors conclude, “We found that targeted use of oral naltrexone was efficacious in reducing alcohol use and craving among SGM who binge drink and have mild to moderate AUD, with sustained effects 6 months after treatment. Retention and treatment engagement were also high. Taken together, these data support the use of targeted dosing of oral naltrexone to address binge drinking in SGM with mild to moderate AUD.”
Santos G-M, Ikeda J, Coffin P, et al. Targeted oral naltrexone for mild to moderate alcohol use disorder among sexual and gender minority men: a randomized trial. Am J Psychiatry. Published online October 26, 2022. doi:10.1176/appi.ajp.20220335