Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Effect of pindolol on subjective response to MDMA
研究概览
简要总结
MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown.
详细描述
We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Sufficient understanding of the German language
- •Subjects understand the procedures and the risks associated with the study
- •Participants must be willing to adhere to the protocol and sign the consent form
- •Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- •Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight of the evening before the study session.
- •Participants must be willing not to drive a traffic vehicle in the evening of the study day.
- •Body mass index: 18-25 kg/m2
排除标准
- •Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
- •Current or previous psychotic or affective disorder
- •Psychotic or affective disorder in first-degree relatives
- •Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
- •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.
研究组 & 干预措施
Pindolol, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
干预措施: MDMA (Drug)
Pindolol, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
干预措施: Pindolol (Drug)
MDMA, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
干预措施: MDMA (Drug)
MDMA, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject.
干预措施: Pindolol (Drug)
结局指标
主要结局
Effect of pindolol on subjective response to MDMA
时间窗: 24h
次要结局
- Effect of pindolol on physiological response to MDMA(24h)