A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Adverse Events
研究概览
简要总结
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
详细描述
The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing.
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Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults.
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Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart.
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Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
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Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults.
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Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort.
Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65-85 years & be male, female, or non-binary
- •Generally healthy
- •Have an identified support person
- •Capacity to Consent
排除标准
- •Unstable medical condition
- •Risk for hypertensive crisis (screening blood pressure >140/90 mmHg)
- •Significant central nervous system (CNS) pathology
- •Primary psychotic or affective psychotic disorders
- •Family history of psychotic or serious bipolar spectrum illnesses
- •High risk of adverse emotional or behavioral reaction
- •Active substance use disorders (SUDs)
- •Extensive use of serotonergic hallucinogens
- •High risk of completed suicide
- •History of hallucinogen persisting perception disorder (HPPD)
- •Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10
- •Certain psychiatric conditions
- •Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study
研究组 & 干预措施
Psilocybin
Two escalating doses of psilocybin 30 days apart
干预措施: Psilocybin (Usona Institute) (Drug)
结局指标
主要结局
Adverse Events
时间窗: up to 14 weeks
Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial
次要结局
- Total drug exposure (Area Under the Curve, AUC)(Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation))
- Elimination Half-life(Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation))
- Maximum concentration (Cmax)(Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation))
- Minimum concentration (Cmin)(Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation))