Comparative Acute Effects of LSD, Psilocybin and Mescaline in a Random-Order Placebo-Controlled Cross-Over Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 5 Dimensions of Altered States of Consciousness (5D-ASC)
研究概览
简要总结
LSD, psilocybin and mescaline are widely used for recreational and ethnomedical purposes. All three substances are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in the substances' molecular structures and receptor activation profiles which may induce differential subjective effects. To date, there are no modern studies comparing LSD, psilocybin and mescaline directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo.
详细描述
LSD (lysergic acid diethylamide), psilocybin (the active substance in "magic mushrooms") and mescaline (the active substance in Peyote and San Pedro cacti) are serotonergic hallucinogens widely used for recreational and/or ethnomedical purposes. LSD, psilocybin and mescaline are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. However, there are differences in their molecular structures (LSD: ergoline, psilocybin: tryptamine; mescaline: phenethylamine)and receptor activation profiles which may induce different subjective effects. To date, there are no modern studies comparing these three substances directly within the same clinical study and research subjects using validated psychometric tools. Therefore, the LPM-Study compares the acute effects of LSD, psilocybin, mescaline and placebo in a double-blind, placebo-controlled, 4-period cross-over design with four treatment conditions: 1) 100 μg LSD, 2) 20 mg psilocybin, 3) 300 or 500 mg mescaline, and 4) placebo. The main objective of this study is to determine whether LSD, psilocybin and mescaline produce qualitatively similar subjective alterations of mind and associated brain activity patterns despite their unique receptor activation profiles. The study investigates psychological (psychometry), physiological and neuronal (magnetic resonance imaging) variables. The LPM-Study provides insight into the acute effects profiles of three serotonergic hallucinogens. It will enhance the understanding of psychedelic-induced altered states of consciousness in humans and will be relevant for the fields of psychiatry, psychology, and forensic toxicology.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 25 and 65 years old
- •Sufficient 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
- •Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
- •Willing not to operate heavy machinery within 48 hours after substance administration
- •Willing to use double-barrier birth control throughout study participation
- •Body mass index between 18-29 kg/m2
排除标准
- •Chronic or acute medical condition
- •Current or previous major psychiatric disorder
- •Psychotic disorder or bipolar disorder in first-degree relatives
- •Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
- •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)
- •Consumption of alcoholic beverages (>20 drinks/week)
- •Failure of MRI-related criteria
研究组 & 干预措施
Mescaline-300/500
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
干预措施: Mescaline (Drug)
LSD-100
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
干预措施: LSD (Drug)
Psilocybin-20
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
干预措施: Psilocybin (Drug)
Placebo
Cross-over within-subject design with all treatment conditions, separated by a wash-out phase of at least 10 days
干预措施: Placebo (Other)
结局指标
主要结局
5 Dimensions of Altered States of Consciousness (5D-ASC)
时间窗: 18 months
5D-ASC subscale ratios
fMRI resting state functional connectivity (RSFC)
时间窗: 18 months
Spontaneous low-frequency fluctuations in BOLD signal during resting state
次要结局
- Visual Analog Scale (VAS)(18 months)
- States of Consciousness questionnaire (SCQ)(18 months)
- Blood pressure(18 months)
- Heart rate(18 months)
- Pupil size(18 months)
- Body temperature(18 months)
- Drug plasma levels(18 months)
- Renal clearance values(18 months)
- NEO-Five-Factor-Inventory (NEO-FFI)(18 months)
- Freiburger Persönlichkeitsinventar (FPI)(18 months)
- Saarbrücker Persönlichkeitsfragebogen (SPF)(18 months)
- Adjective Mood Rating Scale (AMRS)(18 months)
- Oxytocin levels(18 months)
- Blood-derived neurotrophic factor (BDNF)(18 months)
- Mysticism Scale (MS)(18 months)
- Elliot Humility Scale (EHS)(18 months)
- Jankowski Humility Scale (JHS)(18 months)
- Arnett Inventory of Sensation Seeking (AISS-d)(18 months)