Acute Subjective Effects, Physiological Effects, and Pharmacokinetics of Intravenous 5-MeO-DMT Infusions in a Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- University Hospital, Basel, Switzerland
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in subjective effects over time (assessed with subjective effect scales (SES))
概览
简要总结
Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours).
If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance from the investigational substance. Following substance administration, participants will be repeatedly asked to describe their subjective experiences. Blood pressure and heart rate will be monitored regularly, and blood samples will be collected via an intravenous catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Willing not to operate heavy machinery for 48 hours after the study session.
- •Willing to use effective 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 (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
- •Hallucinogenic and/or dissociative 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 (\>15 drinks or \>180g alcohol per week)
研究组 & 干预措施
0.6 mg/min 5-MeO-DMT
0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
干预措施: 0.6 mg/min 5-MeO-DMT (Drug)
0.8 mg/min 5-MeO-DMT
0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
干预措施: 0.8 mg/min 5-MeO-DMT (Drug)
0.2 mg/min 5-MeO-DMT
0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
干预措施: 0.2 mg/min 5-MeO-DMT (Drug)
Placebo
Placebo (saline) will be administered for a total infusion duration of 30 min.
干预措施: Placebo (Drug)
0.4 mg/min 5-MeO-DMT
0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
干预措施: 0.4 mg/min 5-MeO-DMT (Drug)
结局指标
主要结局
Change in subjective effects over time (assessed with subjective effect scales (SES))
时间窗: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.
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 to complete.
次要结局
- Treatment-emergent adverse events (TEAEs)(Up to one week (from substance administration session (Session 2) to end of study visit (EOS, Session 3)))
- Change in Safety lab parameters(Up to 14 days (from Screening (Session 1) until end-of-study-visit (EOS, Session 3)))
- Change in Vital Signs(Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.)
- Change in Adverse effects list (Beschwerdenliste (BL-R)(Up to 4 hours at substance administration session (Session 2) (at baseline and after substance administration))
- Swiss Psychedelic Side Effects Inventory (SPSI)(One time assessment at End-of-study-visit (EOS, Session 3 = 7 days after substance administration))
- Change in Columbia-Suicide-Severity-Rating-Scale (C-SSRS)(Up to 14 days (from Screening (Session 1) to Substance administration session (Session 2) until End-of-study-visit (EOS, Session 3)))
- 5-Dimensions of Altered States of Consciousness Scale (5D-ASC)(One time assessment at substance administration session (Session 2): 3 hours after substance administration)
- States of Consciousness Questionnaire (SCQ)(One time assessment at substance administration session (Session 2): 3 hours after substance administration)
- Ego dissolution inventory (EDI)(One time assessment at substance administration session (Session 2): 3 hours after substance administration)
- Change in Substance plasma concentration(Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.)
- Near-death experience content scale (NDE-C)(One time assessment at substance administration session (Session 2): 3 hours after substance administration)
- Emotional Breakthrough Inventory Plus (EBI+)(One time assessment at substance administration session (Session 2): 3 hours after substance administration)
- PAE-PS-ext (PAE-PS-ext)(One time assessment at substance administration session (Session 2): 3 hours after substance administration.)
- Change in Endocrine lab parameters(Up to 180 minutes at substance administration session (Session 2): 30 and 180 minutes after substance administration.)
- Freiburger Personality Inventory (FPI)(One time assessment at Screening (Session 1 = up to 2 hours))
- NEO Five Factor Inventory (NEO-FFI)(One time assessment at Screening (Session 1 = up to 2 hours))
- Connor-Davidson Resilience Scale (CD-RISC)(One time assessment at Screening (Session 1 = up to 2 hours))
- ABC Connectedness to Nature Scale (ABC-CNS)(One time assessment at Screening (Session 1 = up to 2 hours))
- Urinary excretion of 5-MeO-DMT(Up to 3 hours at substance administration session (Session 2))
- Change in Appreciation Scale (AS)(Up to 14 days (from Screening (Session 1) to End-of-study -visit (EOS, Session 3)))
- Change in Scale of Positive and Negative Experience (SPANE)(Up to 14 days (from Screening (Session 1) to Drug administration session (Session 2) until end-of-study-visit (EOS, Session 3)))
- Change in Global Life Satisfaction (GLS)(Up to 14 days (from Screening (Session 1) to Drug administration session (Session 2) until end-of-study-visit (EOS, Session 3)))
- Change in Credibility/Expectancy Questionnaire (CEQ)(Up to 14 days (from Screening (Session 1) to Drug administration session (Session 2) until end-of-study-visit (EOS, Session 3)))