Drug Effects on Interpersonal Interaction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Profile of Mood States
研究概览
简要总结
The investigators propose to use a Paired Partner design, in which subjects engage in a 45-min semi-structured conversation with one (novel) partner under the influence of MDMA and with another partner under the influence of placebo. At the end of each session, they will rate their feelings about the partner, and on the test day, subjects will be asked which partner they preferred and felt closer to.
详细描述
The study will use a within-subject design with three sessions: i) MDMA and conversation with Person A, ii) placebo and conversation with Person B, iii) test session (online) assessing preference for Persons A and B. The MDMA dose will be 100 mg, administered under double blind conditions. The conversation will consist of a 45 min dialog between the participant and the partner, a person trained to engage in conversation for this purpose. The dyad will be provided with topics to discuss, at their own pace. The order of administration of drug and placebo will be counterbalanced, and the partners will be same-sex and varied across sessions. The primary outcome measures will be feelings of closeness and connection at the end of the two drug sessions, at the online test session and follow-up. After study completion, participants will be fully informed about the study.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English fluency
- •High school level education
- •BMI between 19 and 30
排除标准
- •Diagnosed medical condition
- •women who are nursing, pregnant, or plan to become pregnant within 3 months
- •History of psychotic disorder or family history of psychotic disorder
研究组 & 干预措施
Experimental: Placebo Then MDMA
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 100 mg MDMA.
干预措施: placebo oral tablet (Drug)
Experimental: MDMA Then Placebo
Participants first receive 100 mg MDMA at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.
干预措施: placebo oral tablet (Drug)
Experimental: Placebo Then MDMA
Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 100 mg MDMA.
干预措施: MDMA (Drug)
Experimental: MDMA Then Placebo
Participants first receive 100 mg MDMA at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.
干预措施: MDMA (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