Baclofen to Reduce Alcohol Use in Veterans With HCV
Completed · Phase 4 · Has a placebo group
Conditions studied: Hepatitis C, Alcohol Use Disorders
In brief
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.
Key facts
- Study ID
- NCT01008280
- Run by
- VA Office of Research and Development
- People needed
- 180
- Starts
- 2010-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2016-02-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
- VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
- VA Medical Center, Portland — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.