Extended-release Naltrexone Is Not Linked to Hepatotoxicity in Adults Experiencing Homelessness and Alcohol Use Disorder

J Addict Med. 2023 May-Jun;17(3):363-366. doi: 10.1097/ADM.0000000000001121. Epub 2023 Jan 5.

Abstract

Objectives: The use of extended-release naltrexone (XR-NTX) as treatment for alcohol use disorder (AUD) has been limited by a prior black box warning for hepatotoxicity. We performed a secondary analysis of data from a randomized clinical trial to compare serum liver enzyme levels for those randomized to XR-NTX versus placebo.

Methods: The parent study aimed to test the efficacy of combined pharmacobehavioral harm-reduction treatment in improving alcohol and quality-of-life outcomes for adults experiencing homelessness and AUD. We compared the 2 arms that received intramuscular injections of either 380 mg XR-NTX (n = 74) or placebo (n = 77). Outcomes included ( a ) liver enzyme levels and ( b ) liver enzyme values categorized as normal (<1× upper limit of normal [ULN]), elevated (1-3× ULN), or high (>3× ULN). We performed multinomial logistic regression and negative binomial generalized estimating equations modeling to assess the effects of treatment group and the time × treatment group interaction on liver enzyme outcomes.

Results: The mean age was 47.9 ± 9.9 years, and the mean baseline alcohol consumption was 23.2 ± 14.0 drinks per day. There were no significant differences in the development of liver enzyme elevations 1 to 3× ULN or more than 3× ULN (all P s > 0.25) or in the change in liver enzyme values (all P s > 0.41) between the placebo and the XR-NTX groups over the treatment course.

Conclusions: In our study of adults experiencing homelessness and AUD, receipt of XR-NTX was not associated with hepatotoxicity. These findings support the use of XR-NTX to treat AUD even in patients who are drinking heavily and physiologically dependent on alcohol.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Alcohol Drinking / drug therapy
  • Alcoholism* / drug therapy
  • Alcoholism* / epidemiology
  • Chemical and Drug Induced Liver Injury* / drug therapy
  • Delayed-Action Preparations / therapeutic use
  • Humans
  • Ill-Housed Persons*
  • Injections, Intramuscular
  • Middle Aged
  • Naltrexone / adverse effects
  • Narcotic Antagonists / adverse effects
  • Opioid-Related Disorders* / drug therapy

Substances

  • Naltrexone
  • Narcotic Antagonists
  • Delayed-Action Preparations