Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjective effects of lisdexamphetamine and d-amphetamine
研究概览
简要总结
The study will compare the acute emotional and endocrine effects of equivalent doses of lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and effects of the amphetamines on aspects of social cognition are investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects aged 18-45 years
排除标准
- •Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG.
- •Current or previous psychotic or major affective disorder
- •Psychotic or major affective disorder in first-degree relatives
- •Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months.
- •Pregnant or nursing women.
- •Participation in another clinical trial (currently or within the last 30 days)
- •Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
- •Tobacco smoking (>10 cigarettes/day)
研究组 & 干预措施
Lisdexamfetamine, d-amphetamine, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.
干预措施: Lisdexamfetamine, d-amphetamine, Placebo (Drug)
d-amphetamine, Placebo, Lisdexamfetamine
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.
干预措施: d-amphetamine, Placebo, Lisdexamfetamine (Drug)
Placebo, Lisdexamfetamine, d-amphetamine
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate.
干预措施: Placebo, Lisdexamfetamine, d-amphetamine (Drug)
结局指标
主要结局
Subjective effects of lisdexamphetamine and d-amphetamine
时间窗: 13 hours
Assessment of subjective effects using visual analog scales
Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones
时间窗: 13 hours
Measurement of different circulating hormones before and after drug
次要结局
- Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy(1h)