Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Saline Placebo (Other)
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Psilocybin (Drug)
Outcomes
Primary Outcomes
Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)