Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans: Self-report, Behavioral, and Psychophysiological Measures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
研究概览
简要总结
The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.
详细描述
The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 19-26kg/m, high school education,
- •fluency in English,
- •resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.
排除标准
- •current substance abuse or lifetime substance dependence,
- •regular medication,
- •history of cardiovascular illness,
- •current major Axis I DSM-IV disorder (APA, 2004),
- •mood disorder or psychotic symptoms within the past year.
- •Shift workers and pregnant or nursing mothers will also be excluded.
研究组 & 干预措施
Paired, high reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: methamphetamine (Drug)
Paired, high reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: placebo (Drug)
Paired, low reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: methamphetamine (Drug)
Paired, low reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: placebo (Drug)
Paired no reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: methamphetamine (Drug)
Paired no reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: placebo (Drug)
Unpaired, high reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: methamphetamine (Drug)
Unpaired, high reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: placebo (Drug)
Unpaired, low reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: methamphetamine (Drug)
Unpaired, low reward
All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
干预措施: placebo (Drug)
结局指标
主要结局
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
时间窗: End of study (time 0 and approximately 4 weeks later)
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
次要结局
未报告次要终点