Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjective effect ratings over time
研究概览
简要总结
N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.
详细描述
N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (<20 min). In Ayahuasca, DMT is consumed together with harmala alkaloids that inhibit MAO to increase the oral bioavailablitity of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience and is currently being investigated. However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in 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
- Triple (Participant, Care Provider, Investigator)
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 and during the sessions
- •Willing not to operate heavy machinery within 6 h of DMT 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 (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
- •Psychotic disorder or bipolar disorder in first-degree relatives
- •Hypertension (SBP>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)
研究组 & 干预措施
DMT 1.2 mg/min + dose titration
干预措施: N,N-Dimethyltryptamine (108 mg) + dose titration (Drug)
DMT 0.6 mg/min
干预措施: N,N-Dimethyltryptamine (54 mg) (Drug)
DMT 1.2 mg/min
干预措施: N,N-Dimethyltryptamine (108 mg) (Drug)
DMT 1.8 mg/min
干预措施: N,N-Dimethyltryptamine (162 mg) (Drug)
DMT 2.4 mg/min
干预措施: N,N-Dimethyltryptamine (216 mg) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Subjective effect ratings over time
时间窗: 12 months
Participants will be asked by the investigator to repeatedly rate their subjective effects verbally on a Likert scale from 0 to 10 for: "any drug effect", "good drug effect", "bad drug effect", and "fear". Ratings will be performed before and repeatedly after substance administration and will take approximately 30 sec complete.
Altered states of consciousness profile (5D-ASC)
时间窗: 12 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 with higher scores representing more intense effects. Assessed once on each study day
次要结局
- Plasma level of BDNF(12 months)
- Plasma level of Prolactin(12 months)
- Urine recovery of DMT(12 months)
- NEO-Five-Factor-Inventory (NEO-FFI)(Baseline)
- Saarbrücker Personality Questionnaire (SPF)(Baseline)
- Elliot Humility Scale (EHS)(Baseline)
- body temperature(12 months)
- Plasma level DMT(12 months)
- States of consciousness questionnaire (SCQ)(12 months)
- Spiritual Realms Questionnaire(12 months)
- Blood pressure(12 months)
- heart rate(12 months)
- Plasma level of oxytocin(12 months)
- Plasma level of cortisol(12 months)