Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Mean Standard Drinks Per Drinking Day
研究概览
简要总结
This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
- •interested in cutting down or quitting drinking
- •able to provide voluntary informed consent
- •have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days
排除标准
- •severe liver disease; severe kidney disease; gallbladder disease or gallstones
- •chronic renal or hepatic failure
- •recent pancreatitis
- •insulin-dependent diabetes
- •other urgent medical problems
- •moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)
- •schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
- •current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)
- •active legal problems with the potential to result in incarceration
- •pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)
- •current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics
- •regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68
- •a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years
- •a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30 minutes69)
- •left-handedness
- •any contraindications for MRI
研究组 & 干预措施
Gemfibrozil
Gemfibrozil 600 mg by mouth twice daily
干预措施: Gemfibrozil 600 MG (Drug)
Placebo
Microcrystalline cellulose powder packaged in capsules identical to the experimental condition
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Mean Standard Drinks Per Drinking Day
时间窗: 4 weeks post baseline
Average number of standard drinks consumed on drinking days
Percent Days Abstinent
时间窗: 4 weeks post baseline
Percentage of days of abstinence from alcohol
次要结局
未报告次要终点