Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Drinking Behaviors
研究概览
简要总结
This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.
详细描述
In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of understanding and complying with the protocol
- •Good physical and mental health (normal physical exam, ECG, blood and urine chemistries)
- •Body Mass Index between 18-30, inclusive
- •Age 21-40 years
- •Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
- •Have a stable living situation with current postal address
排除标准
- •Concurrent diagnosis of Axis I disorder
- •Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
- •Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
- •Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
- •Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
- •Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
- •Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
- •Tobacco use greater than 5 cigarettes per day
- •History of major head trauma resulting in cognitive impairment or history of seizure disorder
- •Heavy caffeine use (greater than 500 mg on a regular, daily basis)
- •Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
- •For female volunteers, a positive pregnancy test
结局指标
主要结局
Drinking Behaviors
时间窗: Study end
A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).
次要结局
未报告次要终点
研究者
Scott Lukas
Director, McLean Imaging Center
Mclean Hospital