Hepatitis C Clinical Trial
Official title:
Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
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.
Project: Efficacy of baclofen in reducing alcohol consumption in Veterans with HCV Principal
Investigator: Peter Hauser, MD
Keywords: Hepatitis C, Substance-Related Disorders, Alcoholism
Abstract
PLAN/METHODS: Two sites of the national VA Hepatitis C Resource Center, including
Minneapolis and Portland VA Medical Centers (VAMCs), the Long Beach VAMC, and the San Diego
VAMC (total 4 sites) will recruit 180 men, women, and minority Veterans who are HCV positive
and currently drinking alcohol. Participants will be assessed for current alcohol use and
alcohol use disorders and enrolled in the study if they meet eligibility criteria, mainly
that they are drinking more than 7 drinks a week or have one heavy drinking day a week for
the preceding two weeks. Enrolled subjects will be randomly assigned to one of two groups:
Experimental group (Baclofen) or control (placebo). Subjects will be followed for a total of
14 weeks, and follow-up data will be collected at a total of 11 visits (weeks
1,2,3,4,6,8,10,12, and 14). At each visit, interviews will be conducted by a blinded
interviewer assessing current stage of change and current alcohol use along with any changes
in mood and psychological or somatic symptoms. HCV viral titers will be obtained at baseline
and again at week 12 to determine the effect of abstinence on this measure. Data will also
be collected from participants' medical records regarding enrollment and attendance in
substance abuse treatment or self-help programs (Alcoholics Anonymous). Data will be
analyzed using repeated measure ANOVAs to compare the groups on alcohol use and stage of
change.
CLINICAL RELEVANCE: This study focuses on a current Veterans Health Administration (VHA)
priority: treatment of Veterans with HCV. Alcohol use in this population is a major risk
factor for progression of liver disease. The investigators anticipate that the Baclofen
proposed in this study will result in reduced alcohol use, which is expected to result in a
slowing of the progression of liver disease, improvement in physical health, and a reduction
in long-term service utilization and mortality rates.
POTENTIAL IMPACT ON VETERANS HEALTH CARE: Effectively addressing alcohol use disorders in a
hepatitis clinic will contribute to a new standard of care for HCV patients within the VA.
Co-located care for patients with comorbid medical and substance use disorders is likely to
improve access to effective treatment, acceptance by patients and improve clinical
efficiency.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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