Phase 2
N=308
Harm Reduction With Pharmacotherapy (HaRP)
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01932801 ↗Enrolled (actual)
308
Serious AEs
23.1%
Results posted
May 2023
Primary outcome: Primary: Alcohol Quantity — 27.37; 25.95; 32.02; 32.15 number of drinks on peak occasion — p=.461
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- XR-NTX (Drug); Placebo (Other); HRC (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Quantity |
27.37; 25.95; 32.02; 32.15; 22.4; 18.97 | .461 |
| PRIMARY Alcohol-related Harm |
23.7; 23; 25.69; 22.7; 15.33; 17 | .347 |
| PRIMARY Alcohol Frequency |
23.08; 24.63; 23.42; 23.35; 17.87; 18.81 | .028 sig |
| SECONDARY Motivation to Change Ruler |
6.64; 7.49; 7.05; 6.42; 6.37; 6.98 | .6 |
| SECONDARY Alcohol Craving |
20.74; 21.99; 21.46; 21.70; 18.54; 17.85 | .65 |
| SECONDARY Publicly Funded Service Utilization Costs |
722.32; 829.22; 583.55; 511.62; 1371.51; 871.57 | .95 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01932801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.