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Alcohol Clin Exp Res. 2019 Aug;43(8):1790-1800. doi: 10.1111/acer.14130. Epub 2019 Jul 10.

Reduction in Drinking was Associated With Improved Clinical Outcomes in Women With HIV Infection and Unhealthy Alcohol Use: Results From a Randomized Clinical Trial of Oral Naltrexone Versus Placebo.

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Department of Epidemiology, University of Florida, Gainesville, Florida.
School of Integrated Science and Humanity, Florida International University, Miami, Florida.
Department of Public Health & Medical Affairs, Gilead Sciences Inc., Miami, Florida.
Department of Psychiatry & Behavioral Sciences, University of Miami School of Medicine, Miami, Florida.
Department of Biostatistics, University of Florida, Gainesville, Florida.
Alcohol and HIV/AIDS Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland.



Alcohol consumption is associated with poor health outcomes in women living with HIV (WLWH), but whether medication can help to reduce drinking in non-treatment-seeking women or whether reduction in drinking improves HIV outcomes is unclear. We conducted a randomized clinical trial (RCT) of daily oral naltrexone (50 mg) versus placebo in WLWH who met criteria for current unhealthy alcohol use.


WLWH with current unhealthy alcohol use (>7 drinks/wk or >3 drinks/occasion) were randomly assigned to daily oral naltrexone 50 mg (n = 96) or placebo (n = 98) for 4 months. Drinking outcomes, including the proportion of women who reduced (<unhealthy use criteria) or quit drinking, were assessed at baseline, 2 months, 4 months (end of treatment), and 7 months. In a secondary analysis, HIV viral suppression and changes in CD4 counts were compared in women who did or did not reduce/quit drinking, regardless of intervention assignment.


The participants' mean age was 48 years, 86% were African American, and 94% were receiving HIV antiretroviral therapy. Among all participants, 89% and 85% completed the 4-month and 7-month follow-ups, respectively. Participants in both groups substantially reduced drinking over time. At 1 and 3 months, naltrexone was associated with a greater reduction in drinking (p < 0.05), but the proportion who reduced/quit drinking at 4 months (52% vs. 45%, p = 0.36) or 7 months (64% in both groups) was not different. HIV viral suppression at follow-up was significantly better in participants who reduced/quit drinking versus those continuing unhealthy alcohol use at 4 months (72% vs. 53%, p = 0.02) and 7 months (74% vs. 54%, p = 0.02).


Participating in an RCT to reduce drinking was associated with significant drinking reduction regardless of medication assignment, suggesting that nonmedication aspects of research study participation (e.g., repeated assessments and support from research staff) could be important interventions to help reduce drinking outside of research studies. Drinking reduction was associated with improved HIV viral suppression, providing evidence to support recommendations to avoid unhealthy alcohol use among WLWH.


Alcohol Consumption; HIV Infection; Pharmacotherapy; Randomized Clinical Trial; Women

[Available on 2020-08-01]

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