Harm Reduction With Pharmacotherapy (HaRP)

NCT01932801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2023-05-10

Study results available
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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.

Conditions

Interventions

DRUG

XR-NTX

OTHER

Placebo

BEHAVIORAL

HRC

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Alkermes, Inc.

    collaborator INDUSTRY
  • University of Washington

    lead OTHER

Principal Investigators

  • Susan E Collins, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-01
Primary Completion
2018-10-11
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01932801 on ClinicalTrials.gov