Baclofen to Reduce Alcohol Use in Veterans With HCV (BRAC)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis C Alcohol Use Disorders |
Drug: baclofen Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV |
- percentage of days abstinent [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
baclofen 10 mg po tid
|
Drug: baclofen
baclofen 10 mg tid
|
|
Placebo Comparator: Arm 2
placebo given tid
|
Drug: placebo
placebo pill tid
|
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 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 VHA priority: treatment of veterans with HCV. Alcohol use in this population is a major risk factor for progression of liver disease. We 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion/Exclusion Criteria for Participation Include if:
- Male or female, age 18 or older Medical record shows
- Serum antibody positive for HCV and PCR 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 SCID
- Yes Medical record and self report
- Medical record, self report, SCID, BDI-II
- Able to attend clinic appointments Yes No Self-report
Exclusion Criteria:
Exclusion 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:
- 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, or Methadone
Contacts and Locations| Contact: Peter Hauser, MD | (562) 826-8000 ext 2629 | peter.hauser2@va.gov |
| Contact: Shira A Saperstein | (562) 826-8000 ext x2954 | Shira.Saperstein@va.gov |
| United States, California | |
| VA Medical Center, Long Beach | Recruiting |
| Long Beach, California, United States, 90822 | |
| Contact: Peter Hauser, MD 562-826-8000 ext 2629 peter.hauser2@va.gov | |
| Contact: Timothy Morgan, MD | |
| Principal Investigator: Peter Hauser, MD | |
| VA San Diego Healthcare System, San Diego, CA | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Samuel B Ho MD 858-642-3280 samuel.ho2@va.gov | |
| United States, Minnesota | |
| VA Medical Center, Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Erick Diperink, MD 612-725-2000 ext 2037 erick.diperink@va.gov | |
| United States, Oregon | |
| VA Medical Center, Portland | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Rebecca Lenox, MS 503-220-8262 ext 52802 Rebecca.Lenox2@va.gov | |
| Principal Investigator: | Peter Hauser, MD | VA Medical Center, Long Beach |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01008280 History of Changes |
| Other Study ID Numbers: | NURA-014-09S |
| Study First Received: | November 3, 2009 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alcohol Drinking Hepatitis Hepatitis A Hepatitis C Drinking Behavior Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Baclofen GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013