Phase 4
N=180
Baclofen to Reduce Alcohol Use in Veterans With HCV
Hepatitis C · Alcohol Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01008280 ↗Enrolled (actual)
180
Serious AEs
5.0%
Results posted
Jun 2015
Primary outcome: Primary: Number of Drinking Days in the Past Two Weeks — 8.6; 8.9; 6.8; 7.1 Number of Drinking Days/2 weeks — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- baclofen (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinking Days in the Past Two Weeks |
8.6; 8.9; 6.8; 7.1; 6.2; 6.3 | <0.01 sig |
| PRIMARY Number of Drinks Consumed Per Two Week Segments |
60.09; 67.23; 41.89; 47.68; 33.88; 39.07 | <0.01 sig |
| PRIMARY Number of Heavy Drinking Days Per Two Week Segment |
6.48; 7.18; 3.67; 4.04; 2.59; 3.07 | <0.01 sig |
Summary
Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen is a novel treatment for alcohol use disorders that has minimal effect on the liver and may represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol use disorders.
Eligibility Criteria
Inclusion Criteria
Criteria for Participation Include if:
- Male or female
- Age 18 or older
Medical record shows:
- Serum antibody positive for HCV and PCR (Polymerase Chain Reaction) confirmation, Men or Women: > 7 drinks per week for each of the proceeding 2 weeks Or One heavy drinking day per week for 2 weeks (Heavy drinking day: 5 drinks in one day for men and >4 drinks in one day for women) based on Timeline Followback method (TLFB)
- Alcohol use Disorder (abuse or dependence) based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID)
- Yes Medical record and self report
- Medical record, self report, SCID, Beck Depression Inventory -II (BDI-II)
- Able to attend clinic appointments
- Yes No Self-report
Exclusion Criteria
Criteria for Participation Exclude if:
- Male or female
- Under age 18
- Cocaine, methamphetamine or opioid dependence within the past 6 months*
- Any known pre-existing medical conditions that could interfere with participation in the protocol, such as:
- Central Nervous System (CNS) trauma
- Known cognitive impairment
- Dementia
- Encephalopathy from liver disease
- Acute psychiatric instability, such as significant psychosis, mania, or elevated risk for suicide
- Not able to attend clinic appointments
- Pregnant women
- If any of the following medication are being used:
- Ondansetron
- Disulfiram
- Topiramate
- Naltrexone
- Acamprosate
- Buprenorphine
- Methadone
Data sourced from ClinicalTrials.gov (NCT01008280). 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.