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.

Patient preferences and extended-release naltrexone: A new opportunity to treat opioid use disorders in Ukraine

“…Importantly, XR-NTX would provide more options for patients to receive treatment and foster scale-up of evidence-based treatment for opioid use disorders. Findings here differ from PWID in high-income settings like Vancouver where 52% were willing to consider XR-NTX (2015) and similarly high among PWID with co-morbid opioid and alcohol use disorders transitioning from criminal justice settings (Di Paola et al, 2014; Lee et al, 2016; Lee et al, 2015; Springer et al, 2015; Springer et al, 2014). …”

An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone

“…Projects NEW HOPE (R01DA030762) and INSPIRE (R01AA018944) (Springer, Altice et al 2013) are two NIH-funded double-blinded randomized placebo-controlled trials of XR-NTX among incarcerated HIV-infected men and women with opioid or alcohol dependence, respectively, who are transitioning to the community. The studies are being conducted in Connecticut cities (New Haven, Hartford, Waterbury) and Massachusetts (Springfield) and seek to evaluate the impact of XR-NTX on HIV-related treatment outcomes among HIV-infected participants with substance use disorders.…”

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community

“…Various concerns were addressed in a similar study but were again encountered here [60]. Listed below and in Table 3 are some of the additional barriers that were encountered and overcome during this study.…”

“…The analytic plan for this study is similar to another similarly designed XR-NTX trial that focuses on pre-release prisoners with HIV and alcohol use disorders [60]. Below is a brief description of the planned analysis.…”