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Randomized Controlled Trial
. 2017 May 1:174:158-170.
doi: 10.1016/j.drugalcdep.2017.01.026. Epub 2017 Mar 10.

Extended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community

Sandra A Springer  1 , Angela Di Paola  2 , Marwan M Azar  2 , Russell Barbour  3 , Archana Krishnan  4 , Frederick L Altice  5
Affiliations
Randomized Controlled Trial

Extended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community

Sandra A Springer et al. Drug Alcohol Depend. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Alcohol Use Disorder; Extended-release naltrexone; HIV; Hazardous drinking; Prisoners; Randomized controlled trial.

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Conflict of interest statement

Conflict of Interest: No conflict declared.

Figures

Figure 1
Figure 1
Enrollment Flow Chart
Figure 2
Figure 2
Figure 2A. Retention for Study Injections Figure 2B. Retention for Study Visits
Figure 3
Figure 3
Time to To First Heavy Drinking Day Longer in 20–29 years Age Group Receiving XR-NTX
Figure 4
Figure 4
Comparison of Composite Alcohol Consumption Index, Stratified by Number of XR-NTX Injections
See this image and copyright information in PMC

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