A Laboratory Study on the Interactive Effects of IV Ethanol and IV Nicotine on Subjective Effects and Cognition
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Biphasic Alcohol Effects Scale (BAES)
研究概览
简要总结
There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female;
- •between the ages of 21 and 50 years;
- •medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories
- •history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence
- •social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.
排除标准
- •history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study;
- •regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder;
- •current abuse of any recreational or prescription drugs (except alcohol);
- •alcohol naïve.
研究组 & 干预措施
intravenous ethanol placebo and nicotine infusions
Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations.
干预措施: Intravenous ethanol placebo plus nicotine infusions (Drug)
intravenous ethanol 40% and nicotine infusions
Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations.
干预措施: intravenous ethanol 40mg% plus nicotine infusions (Drug)
intravenous ethanol 100% and nicotine infusions
Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations.
干预措施: intravenous ethanol 100mg% plus nicotine infusions (Drug)
结局指标
主要结局
Biphasic Alcohol Effects Scale (BAES)
时间窗: 2 minutes
A 14-item scale with 7 items designed to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication.
次要结局
- Digit Symbol Substitution Task(2 minutes)
- QSU-Brief(2 minutes)
- Visual Analog Scales of Mood States(1 minute)