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Baclofen to Reduce Alcohol Use in Veterans With HCV (BRAC)

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ClinicalTrials.gov Identifier: NCT01008280
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : June 9, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Alcohol Use Disorders Drug: baclofen Drug: placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
Study Start Date : October 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Baclofen

Arm Intervention/treatment
Experimental: Baclofen
baclofen 10 mg po tid
Drug: baclofen
baclofen 10 mg tid

Placebo Comparator: Placebo
placebo given tid
Drug: placebo
placebo pill tid




Primary Outcome Measures :
  1. Number of Drinking Days in the Past Two Weeks [ Time Frame: 12 Weeks ]
  2. Number of Drinks Consumed Per Two Week Segments [ Time Frame: 12 weeks ]
  3. Number of Heavy Drinking Days Per Two Week Segment [ Time Frame: 12 weeks ]
    A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008280


Locations
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United States, California
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Peter Hauser, MD VA Long Beach Healthcare System, Long Beach, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01008280     History of Changes
Other Study ID Numbers: NURA-014-09S
First Posted: November 5, 2009    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: February 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis C
Alcoholism
Alcohol Drinking
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders