GABRA2 and the Pharmacokinetics of Risk for Alcoholism (GPRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Effect of GABRA2 SNP status on AUD risk
研究概览
简要总结
This study will assess whether the presence of a particular form of a gene, GABRA2, affects the functional responses of the human brain to alcohol administration and will evaluate that relationship in the context of factors known to increase the risk for future alcoholism.
详细描述
Each subject completed a total of 2 2.8 hr-long clamping sessions.Within each session, procedures differed only by the content of the infusate. In one session, 6% ethanol was infused. In the other session, only vehicle was infused, quantifying the placebo response for every subject. The order of alcohol or placebo sessions was counterbalanced; subjects were blind to which session was which; sessions were scheduled to occur approximately 2 weeks apart. Measures were collected before, and at beginning and end of infusion, and included subjective perceptions, EMG, EEG, stop-signal performance, eye movements, and auditory responses. Design allowed analysis of effect of alcohol vs placebo, initial effect of alcohol and acute tolerance to alcohol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •European American male and females between 21-27 years of age.
- •Good health as determined by medical history, physical exam, and laboratory tests.
- •Females must have a negative urine pregnancy (hCG) test at the start of each study session.
- •People who consume 0.10 standard drinks per week (12 g-ethanol) per liter of total body water when averaged over the preceding month, or more, OR who have consumed more than 0.10 standard drinks per liter of total body water on any one occasion in the last month.
排除标准
- •Inability to read or comprehend eighth grade English.
- •Inability to hear or comprehend verbal instructions, or inability or unwillingness to cooperate with the procedures required for the study.
- •Inability to resolve 2 dots, each 2 mm in diameter with centers placed 5 mm apart on a card placed 20 inches from the bridge of the nose, or the need to wear eyeglasses to do so.
- •Current or prior history of any serious disease, including head trauma causing loss of consciousness, cancer, CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or alcohol or drug dependence, but not alcohol abuse or nicotine dependence.
- •Positive hepatitis or HIV test at screening, provided subject consented to these tests.
- •Current or prior history of alcohol-induced flushing reactions.
- •Current diagnosis of Axis-I psychiatric illness.
- •Positive result on urine drug screen obtained at the face-to-face interview.
- •Pregnancy, as determined by urine HcG on each day of laboratory testing, or intention to become pregnant for women.
- •Use of medications known to interact with alcohol within 2 weeks of the study.
结局指标
主要结局
Effect of GABRA2 SNP status on AUD risk
时间窗: Both session responses and lifetime traits will be included in analysis
Results will assess the effect of GABRA2 SNPs on responses to alcohol and traits related to alcoholism risk
次要结局
- Initial response to alcohol(Within 3 hour session)
- Acute tolerance to alcohol(Within 3 hour session)
- Responses to alcohol vs placebo(Within 3 hour session)
研究者
Sean O'Connor
Professor, Department of Psychiatry and Biomedical Engineering
Indiana University