Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Number of Heavy Drinking Days Per Two Week Segment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Baclofen
baclofen 10 mg po tid
干预措施: baclofen (Drug)
Placebo
placebo given tid
干预措施: placebo (Drug)
结局指标
主要结局
Number of Heavy Drinking Days Per Two Week Segment
时间窗: 12 weeks
A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male
Number of Drinks Consumed Per Two Week Segments
时间窗: 12 weeks
Number of Drinking Days in the Past Two Weeks
时间窗: 12 Weeks
次要结局
未报告次要终点