Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation
研究概览
简要总结
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.
详细描述
Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •prior experience with N,N-Dimethyltryptamine (DMT)
- •present proof of vaccination against COVID-19 (Coronavírus)
排除标准
- •heart failure
- •liver failure
- •kidney failure
- •resistant hypertension
- •arrhythmia
- •valvular heart disease
- •chronic obstructive pulmonary disease
- •severe obesity
- •pregnancy
- •thyroid disorders
- •family diagnosis or suspicion of genetic monoamine oxidase deficiency
- •previous adverse response to psychedelic substances
- •present or past symptoms or family members with a psychotic disorder
- •dissociative identity disorder
- •bipolar disorder
- •prodromal symptoms of schizophrenia
- •abuse of alcohol or other psychoactive substances, except tobacco
- •acute or sub-acute risk of suicide
- •flu-like symptoms
研究组 & 干预措施
Group A - single ascending dose
Administration of up to 2 inhaled doses of DMT within a single day (5 mg, followed by 20 mg) with a 2-hour dose interval (5 subjects).
干预措施: N,N-Dimethyltryptamine (Drug)
Group B - single ascending dose
Administration of up to 2 inhaled doses of DMT within a single day (7.5 mg, followed by 30 mg) with a 2-hour dose interval (5 subjects).
干预措施: N,N-Dimethyltryptamine (Drug)
Group C - single ascending dose
Administration of up to 2 inhaled doses of DMT within a single day (10 mg, followed by 40 mg) with a 2-hour dose interval (5 subjects).
干预措施: N,N-Dimethyltryptamine (Drug)
Group D - single ascending dose
Administration of up to 2 inhaled doses of DMT within a single day (12.5 mg, followed by 50 mg) with a 2-hour dose interval (5 subjects).
干预措施: N,N-Dimethyltryptamine (Drug)
Group E - single ascending dose
Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 2-hour dose interval (5 subjects).
干预措施: N,N-Dimethyltryptamine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation
时间窗: up to 1 month after dosing
Evaluate clinical and psychiatry acute risks after DMT treatments assessed by qualitative medical evaluation after dosing.
Heart rate
时间窗: up to 2 hours after each dose
Assessed 20 times on each dose
Respiratory rate
时间窗: up to 2 hours after each dose
Assessed 20 times on each dose
Oxygen saturation
时间窗: up to 2 hours after each dose
Assessed 20 times on each dose
Blood Pressure
时间窗: up to 2 hours after each dose
Assessed 20 times on each dose via systolic and diastolic blood pressure
次要结局
- Plasma level of aspartate transaminase (AST)(up to 2 hours after each dose)
- Plasma level of alanine transaminase (ALT)(up to 2 hours after each dose)
- Evaluate the impact of after DMT on satisfaction with life using scale(up to 1 month after dosing)
- Evaluate the impact of DMT on affect using scale(up to 1 month after dosing)
- Plasma level of C-reactive protein (CRP)(up to 2 hours after each dose)
- Evaluate the impact of DMT on trait and state of anxiety using scale(up to 1 month after dosing)
- Evaluate the impact of DMT on spirituality, religiousness and personal beliefs(up to 1 month after dosing)
- Plasma level of glucose(up to 2 hours after each dose)
- Plasma level of urea(up to 2 hours after each dose)
- Plasma level of total cholesterol(up to 2 hours after each dose)
- Plasma level of creatinine(up to 2 hours after each dose)
- Evaluate the subjective effects of DMT(up to 2 hours after each dose)
- Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography(up to 2 hours after each dose)
- Plasma level of cortisol(up to 2 hours after each dose)
- Evaluate acute effects on cerebral activity using electroencephalography before, during and after the dosing(up to 2 hours after each dose)
- Evaluate the impact of DMT on quality of life using scale(up to 1 month after dosing)