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

Abstract

Background People with opioid dependence and HIV are concentrated within criminal justice settings (CJS). Upon release, however, drug relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, reincarceration and mortality. Extended-release naltrexone (XR-NTX) is an evidence-based treatment for opioid dependence, yet is not routinely available for CJS populations. Methods A randomized, double-blind, placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes. Results We describe the methods and early acceptability of this trial. In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified. Study acceptability was modest, with 132 (66%) persons who consented to participate from 199 total referrals. Overall, 79% of the participants had previously received opioid agonist treatment before this incarceration. Thus far, 65 (49%) of those agreeing to participate in the trial have initiated XR-NTX or placebo. Of the 134 referred patients who ultimately did not receive a first injection, the main reasons included a preference for an alternative opioid agonist treatment (37%), being ineligible (32%), not yet released (10%), and lost upon release before an receiving their injection (14%). Conclusions Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community. The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments.

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). …”

Challenges to implementing opioid substitution therapy in Ukrainian prisons: Personnel attitudes toward addiction, treatment, and people with HIV/AIDS

“…Though preliminary data suggest that opioid antagonists may have some benefit for this population, concerns about cost, uncertainty about release dates and eventual overdose for those not remaining on opioid antagonists (Wolfe et al, 2011) or not transitioning to OST have limited this strategy until more evidence becomes available (Di Paola et al, 2014). Irrespective of whether OST or long-acting opioid antagonist therapies are deployed, both will require organizational change for adoption and expansion where innovations of using medications to treat addiction are counter-intuitive to the CJS (Friedmann et al, 2012; Friedmann et al, 2014; Springer et al, 2011).…”

Attitudes Toward Addiction, Methadone Treatment, and Recovery Among HIV-Infected Ukrainian Prisoners Who Inject Drugs: Incarceration Effects and Exploration of Mediators

“…Though XR-NTX is considered an evidence-based pharmacological treatment for opioid dependence, a 2011 meta-analytic review (91) concluded that evidence to support such strategies for addressing opioid use disorders is currently insufficient. Concerns about cost, uncertainty about release dates, and eventual overdose for those not remaining on opioid antagonists (92) or not transitioning to OAT, have limited this strategy until more evidence becomes available (93). Nonetheless, this strategy is worthy of further pursuit wherever OAT is not available within the CJS.…”