Harm Reduction With Pharmacotherapy (HaRP)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to test the efficacy of extended-release naltrexone and harm
      reduction counseling in reducing alcohol-related harm among homeless people with alcohol
      dependence.
    

Detailed description: 
      Homelessness and alcohol dependence are commonly co-occurring and serious public health
      issues. Unfortunately, abstinence-based alcohol treatment approaches are minimally effective
      in engaging and successfully treating homeless individuals with alcohol dependence. There
      have therefore been calls for more flexible and client-centered approaches tailored to this
      population's needs. Innovative, low-barrier approaches (e.g., Housing First and alcohol
      management programs) have been applied with this population and are efficacious in reducing
      alcohol use and related problems as well as utilization of publicly funded services and
      associated costs. Such approaches have been referred to as harm-reduction interventions
      because they focus on reducing alcohol-related harm for affected individuals and their
      communities without requiring a commitment to abstinence-based goals. Although psychosocial,
      harm-reduction approaches are beginning to proliferate for this population, there are few
      pharmacological counterparts to support and enhance these efforts. One medication that could
      address this treatment gap is extended-release naltrexone (XR-NTX; marketed as Vivitrol®).
      XR-NTX is a 30-day, extended release formulation of the opioid receptor antagonist,
      naltrexone, and is administered monthly via gluteal intramuscular injection. The proposed
      Phase II study features a four-arm RCT (N=300) designed to test the efficacy of XR-NTX as a
      pharmacological adjunct to existing psychosocial harm-reduction services provided by
      community agencies to homeless people with alcohol dependence. The proposed study will
      include a 24-week follow-up and will test the relative efficacy of 3 active treatment
      combinations-1) XR-NTX+harm reduction counseling, 2) placebo+harm reduction counseling and 3)
      harm reduction counseling only (HRC)-compared to the services as usual (TAU) that all
      participants receive from community agencies. This proposed design will allow us to dismantle
      active treatment components and thereby detect potential "placebo effects" of both the
      administration of an injection and attention from a medical professional. In this study,
      there are three primary specific aims. First, we will test the relative efficacy of XR-NTX,
      placebo and HRC compared to TAU in decreasing alcohol quantity, frequency and alcohol-related
      problems. Second, we will test hypothesized mediators of the intervention effects.
      Specifically, we hypothesize that the active treatments will precipitate increases in
      motivation to change and decreases in craving, which, in turn, will mediate the active
      treatment effects on alcohol outcomes. Finally, we will test treatment effects on publicly
      funded service costs (i.e., emergency medical services, ER visits, hospital admissions, and
      county jail). It is hypothesized that XR-NTX, placebo and HRC groups will show greater
      decreases in publicly funded service costs than the TAU group.
    

Intervention name(s): XR-NTX; Placebo; HRC
Intervention type(s): Drug; Other; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: harm reduction, naltrexone, alcohol use disorder, homelessness