Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Altered states of consciousness profile (OAV)
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 intravenous DMT boluses 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). 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 bolus 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
Randomized
Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (5mg) (Drug)
Randomized
Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (10mg) (Drug)
Randomized
Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (15mg) (Drug)
Randomized
Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (20mg) (Drug)
Randomized
Subjects will be administered intravenous DMT in 4 different bolus doses or placebo in randomized, counter-balanced order. The bolus applications will be separated by one hour.
干预措施: Placebo (saline) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (5mg) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (10mg) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (15mg) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (20mg) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: N,N-Dimethyltryptamine (25mg) (Drug)
Dose ecalation
Subjects will be administered a placebo and a maximum of 5 DMT bolus doses in an escalating dose order. The bolus applications will be separated by one hour.
干预措施: Placebo (saline) (Drug)
结局指标
主要结局
Altered states of consciousness profile (OAV)
时间窗: Repeatedly 1 hour after each bolus application
Altered states of consciousness profile (OAV) consisting of 42 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
Subjective effect ratings over time
时间窗: Repeatedly 1 hour after each bolus application
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.
次要结局
- Psychedelic experience questionnnaire (PEQ)(Repeatedly 1 hour after each bolus application)
- Near death experience content scale (NDE-C)(Repeatedly 1 hour after each bolus application)
- Spiritual Realms Questionnaire (SRQ)(Once at the end of study day)
- Elliot Humility Scale (EHS)(Baseline)
- Blood pressure(Repeatedly in short intervals (2-10 minutes) after each bolus application)
- Heart rate(Repeatedly in short intervals (2-10 minutes) after each bolus application)
- Urine recovery of DMT(Once at the end of study day)
- Plasma level DMT(Repeatedly in short intervals (2-10 minutes) after each bolus application)
- NEO-Five-Factor-Inventory (NEO-FFI)(Baseline)
- Saarbrücker Personality Questionnaire (SPF)(Baseline)