Harm Reduction With Pharmacotherapy (HaRP)

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Alkermes, Inc.; National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Criteria

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