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Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community.

ABSTRACT: BACKGROUND:HIV-infected prisoners have a high prevalence of alcohol use disorders and commonly relapse to alcohol soon after release to the community which is linked to high morbidity, poor antiretroviral therapy (ART) adherence and increased sexual risk-taking behaviors. Extended-release naltrexone (XR-NTX) effectively reduces relapse to alcohol in alcohol dependent persons, yet it remains unexamined among criminal justice system (CJS) populations transitioning to the community. METHODS:A randomized double-blind, placebo-controlled trial of XR-NTX to improve HIV treatment outcomes via reducing relapse to alcohol use after prison release for HIV-infected hazardous drinking and alcohol dependent prisoners is discussed. RESULTS:Acceptability of study participation is high with 86% of those referred who met eligibility criteria and 85% of those who were able to receive injections prior to release accepted injections, yet important implementation issues are identified and addressed during the study and are discussed in this paper. CONCLUSION:Medication-assisted therapies for prevention of relapse to alcohol use for CJS populations transitioning to the community, especially for HIV-infected patients, are urgently needed in order to reduce alcohol relapse after release and improve HIV treatment outcomes and contribute to improved individual and public health.

SUBMITTER: Springer SA

PROVIDER: S-EPMC3992862 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community.

Springer Sandra A SA Altice Frederick L FL Herme Maua M Di Paola Angela A

Contemporary clinical trials 20131231 2

<h4>Background</h4>HIV-infected prisoners have a high prevalence of alcohol use disorders and commonly relapse to alcohol soon after release to the community which is linked to high morbidity, poor antiretroviral therapy (ART) adherence and increased sexual risk-taking behaviors. Extended-release naltrexone (XR-NTX) effectively reduces relapse to alcohol in alcohol dependent persons, yet it remains unexamined among criminal justice system (CJS) populations transitioning to the community.<h4>Meth ...[more]

PMID: 24384538

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Project description:Naltrexone, an opioid antagonist, may facilitate reduction in drinking among young adults. We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking.A randomized, double-blind, placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012. Participants were aged 18-25 years and reported ? 4 heavy drinking days in the prior 4 weeks. Interventions included naltrexone 25 mg daily plus 25 mg targeted (at most daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n = 67). All participants received a personalized feedback session and brief counseling every other week. Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period. Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration (BAC) levels ? 0.08 g/dL.Of 140 randomized patients, 128 began treatment, comprising the evaluable sample. During treatment, percent heavy drinking days (naltrexone: mean = 21.60, SD = 16.05; placebo: mean = 22.90, SD = 13.20) (P = .58) and percent days abstinent (naltrexone: mean = 56.60, SD = 22.52; placebo: mean = 62.50, SD = 15.75) (P = .39) did not differ by group. Naltrexone significantly reduced the number of drinks per drinking day (naltrexone: mean = 4.90, SD = 2.28; placebo: mean = 5.90, SD = 2.51) (P = .009) and percentage of drinking days with estimated BAC ? 0.08 g/dL (naltrexone: mean = 35.4, SD = 28.40; placebo: mean = 45.7, SD = 26.80) (P = .042). There were no serious adverse events. Sleepiness was more common with naltrexone.Naltrexone did not reduce frequency of drinking or heavy drinking days, but reduced secondary measures of drinking intensity. While effects were modest, the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce the amount of alcohol they drink.ClinicalTrials.gov identifier: NCT00568958.

Dataset Information

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community.

Publications

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community.

Similar Datasets

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