Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in a Randomized, Placebo-controlled, Cross-over Trial in Healthy Participants (LPD-Study)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Altered state of consciousness profile (5D-ASC)
研究概览
简要总结
The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. A DMT infusion mimicking oral LSD and psilocybin administrations will be tested, as well as intravenously administered ketanserin.
详细描述
Lysergic acid diethylamide (LSD), psilocybin, and N,N-dimethyltryptamine (DMT) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. They are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-HT)2A receptor. However, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. Moreover, they exhibit different pharmacokinetic qualities. In comparative studies of LSD and psilocybin blinding was impaired by the different duration of subjective effects. This study aims to ensure blinding by ending all experiences at the same time with the 5HT2A antagonist ketanserin. Moreover, no study has yet directly compared DMT to LSD and psilocybin. The DMT infusion will be modeled in accordance with the course of an oral LSD and psilocybin administration. Therefore, the LPD-study compares the acute and subacute effects of LSD, psilocybin, and DMT while standardizing the time course and the duration of action for all substances.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good understanding of the German language
- •Understanding of procedures and risks associated with the study
- •Willing to adhere to the protocol and signing of the consent form
- •Willing to refrain from the consumption of illicit psychoactive substances during the study
- •Willing not to operate heavy machinery within 48 h after administration of a study substance
- •Willing to use effective birth control throughout study participation
- •Body mass index 17 - 34.9 kg/m2
排除标准
- •Relevant chronic or acute medical condition
- •Current or previous major psychiatric disorder (e.g. psychotic disorder)
- •Psychotic disorder or bipolar disorder in first-degree relatives
- •Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- •Bradycardia (< 45 bpm)
- •Prolonged QTc interval (males: >450 ms, females: >470 ms)
- •AV block II° (Mobitz type and Webckebach type) and III°
- •Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
- •Pregnancy or current breastfeeding
- •Participation in another clinical trial (currently or within the last 30 days)
- •Use of medication that may interfere with the effects of the study medication
- •Tobacco smoking (>10 cigarettes/day)
- •Excessive consumption of alcoholic beverages (>15 drinks/week)
研究组 & 干预措施
LSD
150 µg lysergic acid diethylamide followed by 20 mg ketanserin intravenously after 3 h
干预措施: LSD (Drug)
Psilocybin
30 mg Psilocybin followed by 20 mg ketanserin intravenously after 3 h
干预措施: Psilocybin (Drug)
DMT
Dose escalating DMT intravenous infusion up to 2 mg/min followed by 20 mg ketanserin intravenously after 3 h
干预措施: DMT (Drug)
Placebo
Placebo followed by 20 mg ketanserin intravenously after 3 h
干预措施: Placebo (Drug)
结局指标
主要结局
1. Altered state of consciousness profile (5D-ASC)
时间窗: 18 months
5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects.
次要结局
- Subjective effects (VASs)(18 months)
- Mystical-type experiences (PES)(18 months)
- Mystical-type experiences (PAE-PS-ext)(18 months)
- 3. Emotional breakthrough inventory (EBI+)(18 months)
- Plasma levels of LSD(18 months)
- Plasma levels of psilocybin(18 months)
- Plasma levels of DMT(18 months)
- Plasma levels of ketanserin(18 months)
- Plasma levels of oxytocin(18 months)
- Plasma levels of prolactin(18 months)
- Plasma levels of cortisol(18 months)
- Autonomic effects I(18 months)
- Autonomic effects II(18 months)
- Autonomic effects III(18 months)
- Adverse effects (B-LR)(18 months)
- Adverse effects (SPSI)(18 months)
- Adverse Events (AE)(18 months)