Baclofen to Reduce Alcohol Use in Veterans With HCV

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.

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