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Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial

Abstract

We sought to test the efficacy of extended-release naltrexone (XR-NTX) on HIV-related and drinking outcomes. From April 2011-February 2015, we conducted a 4-site randomized double-blind placebo controlled clinical trial involving 51 HIV-positive patients with heavy drinking and < 95% antiretroviral (ART) adherence. All participants received counseling. The primary outcome was proportion with ≥ 95% ART adherence. Secondary outcomes included HIV biomarkers, VACS Index score, and past 30-day heavy drinking days. Based on receipt of ≥ 5 injections, 23 participants were retained at 24 weeks. We did not detect an effect of XR-NTX on ART adherence (p = 0.38); undetectable HIV viral load (p = 0.26); CD4 cell count (p = 0.75) or VACS Index score (p = 0.70). XR-NTX was associated with fewer heavy drinking days (p = 0.03). While XR-NTX decreases heavy drinking days, we did not detect improvements in ART adherence or HIV outcomes. Strategies to improve retention in alcohol treatment and HIV-related outcomes among heavy drinking HIV-positive patients are needed.

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Acknowledgements

We would like to acknowledge Ms. Orli Florsheim, Dr. Lydia Barakat, Dr. Michael Kozal and Mr. Steven Farber for their contributions and support in conducting this work.

Disclosures

An earlier version of this work was presented at the Research Society on Alcoholism Annual Conference, June 26, 2017, in Denver, Colorado.

Funding

This study was funded by the U.S. National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism (5R01AA018923). EJ Edelman was supported as a Yale Drug Abuse, Addiction, and HIV Research Scholar during the conduct of this work (NIDA K12 DA033312). Alkermes donated medication for this study.

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Correspondence to E. Jennifer Edelman.

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Edelman, E.J., Moore, B.A., Holt, S.R. et al. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav 23, 211–221 (2019). https://doi.org/10.1007/s10461-018-2241-z

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Keywords

  • HIV
  • Alcohol
  • Extended-release naltrexone
  • Randomized clinical trial