Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Physiological Effects
研究概览
简要总结
To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.
详细描述
The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25 to 50
- •Comfortable speaking and writing in English
- •Commit to attending all study visits and remote data collection tasks
- •No planned surgeries during the study
- •Had at least one prior experience with a psychedelic substance
- •Generally mentally and physically healthy
- •Agree to abstain from THC, CBD, or nicotine products during study
排除标准
- •Participated in another clinical trial within 30 days of entry to this trial
- •Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
- •A health condition that makes study unsafe or unfeasible, determined by study physicians
研究组 & 干预措施
Oral & Sublingual Psilocin, & Oral Psilocybin
Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.
干预措施: Psilocin (Drug)
Oral & Sublingual Psilocin, & Oral Psilocybin
Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.
干预措施: Psilocybin (Drug)
Oral & Sublingual Psilocin, & Oral Psilocybin
Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order.
干预措施: Sublingual Psilocin (Drug)
Sublingual Psilocin
Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time.
干预措施: Sublingual Psilocin (Drug)
结局指标
主要结局
Physiological Effects
时间窗: Baseline to 8 hours following drug delivery
heart rate
Adverse Effects
时间窗: Baseline to 24 hours after dosing session
* Acute hypertension, hypotension, tachycardia, or bradycardia will be detected through blood pressure and heart rate monitoring at 10 minutes prior to drug administration and measured frequently up to 360 minutes following administration * Other dosing-related side effects including descriptive reports of nausea, headaches, dizziness, weakness, drowsiness, paresthesia, or blurred vision will be assessed during check-ins, after dosing effects have waned, and 24 hours following dosing
Psychological Effects
时间窗: Baseline to 4 weeks after drug delivery
- Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session
次要结局
未报告次要终点
研究者
Joshua Woolley, MD/PhD
Associate Professor, Psychiatry
University of California, San Francisco