Hepatitis C Clinical Trial
— BRACOfficial title:
Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
Verified date | January 2016 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | September 2015 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California |
United States | VA Medical Center, Minneapolis | Minneapolis | Minnesota |
United States | VA Medical Center, Portland | Portland | Oregon |
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Drinking Days in the Past Two Weeks | 12 Weeks | No | |
Primary | Number of Drinks Consumed Per Two Week Segments | 12 weeks | No | |
Primary | Number of Heavy Drinking Days Per Two Week Segment | A heavy drinking day was defined as =4 drinks/ day if female or =5 drinks/day if male | 12 weeks | No |
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