Pharmacokinetics of Didehydro-LSD (DDH-LSD) Compared With LSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Determine effective DDH-LSD dose
研究概览
简要总结
This study investigates DDH-LSD, a novel LSD-like compound expected to have a shorter duration of action than LSD. In healthy volunteers, pharmacokinetics, safety, and subjective effects, will be assessed and compare with LSD in a controlled cross-over study.
详细描述
LSD is a classical serotonergic psychedelic that produces profound alterations in perception and consciousness, primarily through 5-HT2A receptor agonism. Numerous LSD analogs have emerged in recent years, some functioning as prodrugs of LSD, while others show distinct pharmacological characteristics. DDH-LSD is a newly synthesized lysergamide with LSD-like receptor activity but faster metabolism in vitro, suggesting a shorter elimination half-life and potentially briefer psychedelic effects.
This study consists of two parts.
Substudy 1 is an open-label dose-escalation trial in which healthy participants receive increasing doses of DDH-LSD to identify a dose that produces clear but tolerable psychoactive effects.
Substudy 2 is a randomized, double-blind, placebo-controlled cross-over study comparing the selected DDH-LSD dose with LSD and placebo. Each participant completes multiple supervised study days with comprehensive assessment of subjective effects, physiological responses, and pharmacokinetics.
The goal is to provide first-in-human data on DDH-LSD, characterize its effect profile, and evaluate how its duration of action compares with LSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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 and during the sessions
- •Willing not to operate heavy machinery within 48 h of substance administration
- •Willing to use effective contraceptive measures throughout study participation
- •Body mass index between 18-32 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 (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
- •Use of hallucinogenic substances (not including cannabis) more than 20 times or any time within the previous two months
- •Pregnancy or currently 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)
研究组 & 干预措施
Placebo
Participants receive a placebo dose. The session lasts approximately 13 hours with monitoring of the same parameters to control for expectancy and procedural effects.
干预措施: Placebo (Drug)
DDH-LSD
Participants receive a single dose of DDH-LSD at the dose determined in Substudy 1. The session lasts approximately 13 hours with monitoring of subjective, physiological, and pharmacokinetic effects.
干预措施: DDH-LSD (Drug)
LSD
Participants receive a single 0.1 mg dose of LSD. The session lasts approximately 13 hours with monitoring of subjective, physiological, and pharmacokinetic effects.
干预措施: LSD (Drug)
结局指标
主要结局
Determine effective DDH-LSD dose
时间窗: During each 13-hour study session.
Identify the dose of DDH-LSD that produces clear psychoactive effects.
Compare duration of action and elimination half-life
时间窗: During each 13-hour study session.
Compare DDH-LSD with LSD and placebo regarding elimination half-life and duration of subjective effects.
次要结局
- Subjective effects: 5-Dimensions of Altered States of Consciousness (5D-ASC)(Following each 13-hour study session)
- Pharmacokinetics of DDH-LSD(During each 13-hour study session)
- Subjective effects: Visual Analog Scales (VAS)(During each 13-hour study session)
- Effect on heart rate (HR)(During each 13-hour study session)
- Subjective effects: Adjective Mood Rating Scale (AMRS / EWL60S)(Following each 13-hour study session)
- Effect on blood pressure(During each 13-hour study session)
- Subjective effects: Spiritual Realm Questionnaire (SRQ)(Following each 13-hour study session)
- Subjective effects: States of Consciousness Questionnaire (SCQ / MEQ)(Following each 13-hour study session)
- Effect on body temperature(During each 13-hour study session)
- Subjective effects: Scale of Positive and Negative Experience (SPANE)(Before each 13-hour study session)
- Subjective effects: Psychological Insight Questionnaire (PIQ)(Following each 13-hour study session)