Baclofen to Reduce Alcohol Use in Veterans With HCV

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Baclofen

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