Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
研究概览
简要总结
This study is exploring how psilocybin (a psychedelic drug) may improve mood and wellbeing. Many people report feeling better after taking psilocybin, but it is not clear why. The CoPEWell study will test whether these improvements come from the psychedelic experience itself (the "trip") or from direct effects on the brain. To study this, up to 120 participants will be enrolled to receive psilocybin either while awake or asleep and can expect to be on study for up to 4 months.
详细描述
Primary Objectives:
- To evaluate the effect of psilocybin on wellbeing when administered while awake vs. while asleep
- To evaluate the effect of psilocybin on wellbeing administered while asleep vs. placebo administered while asleep
Secondary Objectives: 3. To evaluate the effect of psilocybin on psychological flexibility when administered while awake vs. while asleep 4. To evaluate the effect of psilocybin on psychological flexibility administered while asleep vs. placebo administered while asleep 5. To evaluate the effect of psilocybin on social connectedness when administered while awake vs. while asleep 6. To evaluate the effect of psilocybin on social connectedness administered while asleep vs. placebo administered while asleep 7. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while awake vs. while asleep 8. To evaluate the effect on wellbeing/life satisfaction/purpose/meaning explicitly ascribed to psilocybin administered while asleep vs. saline placebo administered while asleep
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age 18 to 45 years (inclusive) at screening, of any identified gender and racial/ethnic group
- •Physically healthy; does not meet criteria for an exclusionary medical condition
- •No exclusionary sleep condition
- •English-speaking (able to provide consent and complete questionnaires)
- •Sub-optimal self-reported wellbeing
排除标准
- •Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
- •Exclusionary medical conditions or sleep conditions
- •Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
- •Clinically significant electrocardiogram (ECG)
- •Use of psychotropic or CNS-altering medications within 3 months of screening
- •Hypertension or tachycardia
研究组 & 干预措施
Psilocybin While Awake, Placebo While Asleep
Participants in this group will receive psilocybin by intravenous (IV) infusion while awake and placebo (saline) by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Psilocybin (Drug)
Placebo While Awake, Psilocybin While Asleep
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and psilocybin by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Saline Placebo (Other)
Placebo While Awake, Placebo While Asleep
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and placebo by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Clonidine (Drug)
Psilocybin While Awake, Placebo While Asleep
Participants in this group will receive psilocybin by intravenous (IV) infusion while awake and placebo (saline) by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Saline Placebo (Other)
Placebo While Awake, Placebo While Asleep
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and placebo by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Saline Placebo (Other)
Placebo While Awake, Psilocybin While Asleep
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and psilocybin by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Clonidine (Drug)
Psilocybin While Awake, Placebo While Asleep
Participants in this group will receive psilocybin by intravenous (IV) infusion while awake and placebo (saline) by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Clonidine (Drug)
Placebo While Awake, Psilocybin While Asleep
Participants in this group will receive placebo (saline) by intravenous (IV) infusion while awake and psilocybin by IV infusion while asleep during an overnight dosing visit. All participants will also receive oral clonidine prior to dosing to support sleep during the overnight visit.
干预措施: Psilocybin (Drug)
结局指标
主要结局
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
时间窗: Baseline 2 (Day 0) to post-dosing Day 29
WEMWBS is a 14-item survey scored on a 5 point likert scale. The total range in scores is from 14 to 70 where higher scores indicate better mental wellbeing. Reported here for psilocybin administered while awake to psilocybin administered while asleep.
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Asleep versus Placebo Asleep
时间窗: Baseline 2 (Day 0) to post-dosing Day 29
WEMWBS is a 14-item survey scored on a 5 point likert scale. The total range in scores is from 14 to 70 where higher scores indicate better mental wellbeing. Reported here for psilocybin administered while asleep to and placebo administered while asleep.
次要结局
- Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep(Baseline 2 (Day 0) to post-dosing Day 29)
- Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep(Baseline 2 (Day 0) to post-dosing Day 29)
- Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep(Baseline 2 (Day 0) to post-dosing Day 29)
- Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep(Baseline 2 (Day 0) to post-dosing Day 29)
- Persisting Effects Questionnaire (PEQ): Psilocybin Awake versus Asleep(post-dosing Day 29)
- Persisting Effects Questionnaire (PEQ): Psilocybin Asleep versus Placebo Asleep(post-dosing Day 29)