Extended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community.
Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs.



A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters.



There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who received XR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences.



Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events.
Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States. Electronic address: Sandra.springer@yale.edu.
Sandra A
SA
Springer
Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States.
Angela
A
Di Paola
Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States.
Marwan M
MM
Azar
Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States.
Russell
R
Barbour
State University of New York at Albany, Department of Communication, Albany, NY, United States.
Archana
A
Krishnan
Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Division of Epidemiology of Microbial Diseases, New Haven, CT, United States; Centre of Excellence in Research in AIDS (CERiA), University of Malaya, Kuala Lumpur, Malaysia.
Frederick L
FL
Altice
D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D011329:Prisoners; D016896:Treatment Outcome; D055815:Young Adult
D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
Alcohol Use Disorder; Extended-release naltrexone; HIV; Hazardous drinking; Prisoners; Randomized controlled trial