Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number and nature of adverse events associated with the administration of a single dose of IV psilocybin
研究概览
简要总结
This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.
详细描述
The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.
This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.
The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.
Adaptive Study Design Change per Protocol Amendment Approved 5/21/24
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants may receive placebo (saline) or psilocybin during their treatment on overnight 2 but will not be told which they will receive.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy
- •English-speaking
- •Live within 150 miles of Madison, WI for duration of study
排除标准
- •Current use of medications that may interact with psilocybin
- •Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
- •Females with positive urine pregnancy at any time point during screening or study participation
- •Current cardiac valve disease
研究组 & 干预措施
Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
Participants will receive 10 mL of placebo (saline) over 2 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 2 minutes while asleep during their second overnight visit.
干预措施: Psilocybin (Drug)
Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
Participants will receive 10 mL of placebo (saline) over 2 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 2 minutes while asleep during their second overnight visit.
干预措施: Clonidine (Drug)
Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
Participants will receive 10 mL of placebo (saline) over 2 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 2 minutes while asleep during their second overnight visit.
干预措施: Saline (Other)
Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants
If Group 1A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 1B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 2 minutes while awake.
干预措施: Psilocybin (Drug)
Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants
If Group 1A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 1B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 2 minutes while awake.
干预措施: Clonidine (Drug)
Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
If Group 1A participants fail to sleep 1 hour post-dose, Group 2A moves forward. Participants will receive 10 mL of placebo (saline) over 10 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 10 minutes while asleep during their second overnight visit.
干预措施: Psilocybin (Drug)
Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
If Group 1A participants fail to sleep 1 hour post-dose, Group 2A moves forward. Participants will receive 10 mL of placebo (saline) over 10 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 10 minutes while asleep during their second overnight visit.
干预措施: Clonidine (Drug)
Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants
If Group 1A participants fail to sleep 1 hour post-dose, Group 2A moves forward. Participants will receive 10 mL of placebo (saline) over 10 minutes while asleep during their first overnight visit. Participants will receive 0.2 mg oral clonidine and either 2 mg of IV psilocybin or saline over 10 minutes while asleep during their second overnight visit.
干预措施: Saline (Other)
Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants
If Group 2A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 2B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 10 minutes while awake.
干预措施: Psilocybin (Drug)
Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants
If Group 2A participants can sleep 1 hour post-dosing and/or have no memory of dosing, Group 2B moves forward and participants will receive 0.2 mg clonidine and 2 mg of IV psilocybin over 10 minutes while awake.
干预措施: Clonidine (Drug)
Group 1C: 2-minute IV Psilocybin Alone in Awake Participants
If Group 1A allows for sleep 1 hour post dose, Group 1C will move forward and participants will receive 2mg of IV psilocybin over 2 minutes while awake for comparison.
干预措施: Psilocybin (Drug)
Group 2C: 10-minute IV Psilocybin Alone in Awake Participants
If Group 2A allows for sleep 1 hour post dose, Group 2C will move forward and participants will receive 2mg of IV psilocybin over 10 minutes while awake for comparison.
干预措施: Psilocybin (Drug)
Initial Groups 1A and 2A
Participants will receive 2mg of IV psilocybin over 2 minutes or 10 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 2 minutes or 10 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol.
干预措施: Psilocybin (Drug)
Initial Groups 1A and 2A
Participants will receive 2mg of IV psilocybin over 2 minutes or 10 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 2 minutes or 10 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol.
干预措施: Saline (Other)
结局指标
主要结局
Number and nature of adverse events associated with the administration of a single dose of IV psilocybin
时间窗: Up to 9 days
Adverse events associated with the administration of a single dose of IV psilocybin administered either alone or in combination with oral clonidine in asleep and awake participants. Adverse event grading will be done using Common Terminology Criteria for Adverse Event (CTCAE)Adverse events will be graded from Grade 1-5 depending on severity. Grade 1 - mild, grade 2 - moderate, grade 3 - severe, grade 4 - Life threatening, grade 5 - Fatal. Adverse events will be collected on an Adverse Event Log throughout the study.
次要结局
- Number of participants administered psilocybin plus clonidine while asleep who remain asleep for at least 1 hour post dosing and/or report no memory of the dosing experience upon awakening(1 day)
- Post-dosing scores on the Ego Dissolution Inventory (EDI) following administration of IV psilocybin either alone or in combination with clonidine while awake(1 day)
- Post-dosing scores on the 30-item Mystical Experiences Questionnaire (MEQ30) following administration of psilocybin and clonidine while asleep or awake(1 day)
- Post-dosing scores on the Psychological Insight Scale (PIS) following administration of IV psilocybin either alone or in combination with clonidine while awake(1 day)
- Post-dosing scores on the Emotional Breakthrough Inventory (EBI) following administration of IV psilocybin either alone or in combination with clonidine while awake(1 day)
- Post-dosing scores on the Awe Experiences Scale (AWE) following administration of IV psilocybin either alone or in combination with clonidine while awake(1 day)
- Post-dosing scores on the Altered States of Consciousness Questionnaire (ASC) following administration of IV psilocybin while either alone or in combination with clonidine while awake(1 day)
- Post-dosing scores on the Challenging Experiences Questionnaire (CEQ) following administration of IV psilocybin either alone or in combination with clonidine while awake(1 day)
- World Health Organization Well-Being Index(Up to 19 days)
- Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) score 7 days post administration of IV psilocybin either alone or in combination with clonidine while awake(Up to 19 days)