Harm Reduction With Pharmacotherapy (HaRP)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Masking of the double-blind portion of the study was quadruple until after all data had been collected, when they were unblinded.

Study Groups

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Assessment-only

Assessment-only control condition

Group Type NO_INTERVENTION

No interventions assigned to this group

HRC

Harm reduction counseling, which entails provision of feedback and support of harm reduction goals and safer drinking provided at one-month intervals over a 3-month period.

Group Type ACTIVE_COMPARATOR

HRC

Intervention Type BEHAVIORAL

XR-NTX+HRC

3 doses of active medication (380 mg injection/month) + Harm reduction counseling at one-month intervals over three months.

Group Type EXPERIMENTAL

XR-NTX

Intervention Type DRUG

HRC

Intervention Type BEHAVIORAL

Placebo+HRC

3 doses of placebo + harm reduction counseling at one-month intervals over a three-month period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

HRC

Intervention Type BEHAVIORAL

Interventions

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XR-NTX

Intervention Type DRUG

Placebo

Intervention Type OTHER

HRC

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* being a registered client at one of the named partnering sites
* being at least 21 years of age (for legal reasons)
* agreeing to use an adequate form of birth control (if female and in childbearing years) fulfilling criteria for current alcohol dependence according to DSM-IV-TR criteria as determined by the SCID-I/P

Exclusion Criteria

* refusal or inability to consent to participation in research
* constituting a risk to safety and security of other clients or staff
* known sensitivity or allergy to naltrexone/XR-NTX
* current treatment with naltrexone/XR-NTX
* being pregnant or nursing
* suicide attempts within the past year
* renal insufficiency/serum creatinine level \> 1.5
* current opioid dependence according to the DSM-IV-TR criteria
* liver transaminases (AST, ALT) \> 5 times the upper limit of normal (ULN)
* clinical diagnosis of decompensated liver disease

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No