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

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 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. 9.5 days; p <0.001). There were no statistically significant differences for other individual drinking outcomes. A sub-analysis 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 (.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.

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

“…PEth results supported these findings. While these findings contrast with findings from a recent study examining the impact of XR-NTX vs. placebo among HIV-positive people released from prison, in which an effect on alcohol was not observed in the main analysis, they are consistent with findings in the afore referenced pilot(25, 26). Interestingly, our findings were observed as an overall group effect with significant differences between groups at each time point during the treatment phase and at 12 months.…”

“…Since XR-NTX’s Food and Drug Administration’s approval in 2006 for treating alcohol dependence, few studies have evaluated the impact of XR-NTX on HIV-related outcomes. Prior studies are limited to one that enrolled individuals released from prison and a pilot study conducted in HIV treatment settings(25, 26). …”

Medications for Treatment of Opioid Use Disorder among Persons Living with HIV

“…This study suggests the risk of hepatotoxicity is minimal in HIV-infected participants treated with naltrexone, and that there are no adverse immunologic or virologic effects of treatment. The safety of extended-released naltrexone (XR-NTX) is further demonstrated in PLH randomized to XR-NTX following release from prison, who experienced no change in hepatic enzymes compared to those receiving placebo in two double-blind, placebo-controlled randomized trials in PLH with alcohol use disorders and those with opioid use disorders [41], nor in the completed trials themselves [12, 42, 43]. HIV/HCV co-infection has no effect on XR-NTX hepatic safety [44].…”

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review

“…As shown in Table 1, two of these studies have used oral naltrexone (NTX) [44,49] and the 5 other used extendedrelease injectable form (XR-NTX) [45][46][47][48]50]. The difference between reported outcomes and a small number of studies has made it difficult to present results in a metaanalysis.…”

“…According to Cook et al, 2017 the most common side effects for NTX users were: insomnia (30%), nervousness/anxiety (30%), and nausea (10%). Also, Springer et al, 2017 reported no statistical differences in adverse events between the XR-NTX or placebo groups [50]. In another study by Edelman et al 2019, 51% of participants experienced one or more adverse events with mild to moderate severity and 18% had a serious adverse event.…”