Harm Reduction With Pharmacotherapy (HaRP)

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT01932801

Run by

University of Washington

People needed

308

Starts

2013-08-01

Expected to finish

2019-06-30

Last updated by the study team

2023-05-10

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington - Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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