Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Rate at which alcohol enters the brain
研究概览
简要总结
This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
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, no psychopathologies)
- •Body Mass Index between 18-30, inclusive
- •Age 21-40 years
- •Moderate alcohol drinkers (less than 20 drinks/week)
- •Have a stable living situation with current postal address
- •No contraindications to MR scanning (see MR scanning
排除标准
- •Exclusion Criteria:
- •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.
- •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 10 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)
- •For female volunteers, a positive pregnancy test
研究组 & 干预措施
Placebo
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session.
During the medication week, participants will take 2 capsules three times a day.
干预措施: Kudzu extract (Dietary Supplement)
Kudzu extract treatment
Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session.
During the medication week, participants will take 2 capsules three times a day for a total dose of 3 grams of kudzu.
干预措施: Kudzu extract (Dietary Supplement)
结局指标
主要结局
Rate at which alcohol enters the brain
时间窗: 2.5 hours after drug administration
To determine the effects of kudzu extract treatment on the rate at which alcohol enters the brain and to determine if this is due to a change in cerebral blood flow as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
次要结局
- Impact of alcohol and kudzu on resting state networks (RSN).(2.5 hours after drug administration)
研究者
Scott Lukas
Director, McLean Imaging Center
Mclean Hospital