Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Profile of Mood States
研究概览
简要总结
To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 19 and 30 (no one under 130 lbs)
- •Smokers smoking less than 25 cigarettes per week
- •Have used ecstasy no more than 40 times with no adverse responses.
排除标准
- •High blood pressure
- •Any medical condition requiring regular medication
- •Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- •Individuals with a history of dependence on stimulant drugs.
- •Women who are pregnant or trying to become pregnant
研究组 & 干预措施
Experimental: Placebo Then MDMA Then Methamphetamine
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: MDMA (Drug)
Experimental: Placebo Then MDMA Then Methamphetamine
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: Methamphetamine (Drug)
Experimental: Placebo Then MDMA Then Methamphetamine
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: placebo oral tablet (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: MDMA (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: Methamphetamine (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
干预措施: placebo oral tablet (Drug)
Experimental: Methampetamine Then Placebo Then MDMA
Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.
干预措施: MDMA (Drug)
Experimental: Methampetamine Then Placebo Then MDMA
Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.
干预措施: Methamphetamine (Drug)
Experimental: Methampetamine Then Placebo Then MDMA
Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.
干预措施: placebo oral tablet (Drug)
结局指标
主要结局
Profile of Mood States
时间窗: Time Frame: Baseline-72 hours after completion of the sessions
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
次要结局
未报告次要终点