Baclofen to Reduce Alcohol Use in Veterans With HCV
Condition: Hepatitis C; Alcohol Use Disorders
MeSH terms: Hepatitis C; Alcoholism; Alcohol Drinking
Intervention: baclofen; placebo
Intervention description: baclofen 10 mg tid; placebo pill tid
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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