Psychedelic Experiences, Well-Being, Psychological
Conditions
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: 1. To evaluate the effect of psilocybin on wellbeing when administered while awake vs. while asleep 2. 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
Interventions
DRUGPsilocybin
IV administration, infusion of 3.2 mg psilocybin over 10 minutes, followed by an additional 0.8 mg infused over the following 20 minutes
OTHERSaline Placebo
IV administration, placebo will be 20 mL of saline drawn up aseptically into the same sized (30 mL) syringe as is used for the active drug.
DRUGClonidine
0.2 mg of clonidine will be taken by mouth by all participants 60 minutes prior to the initial infusion on Dosing Night
Sponsors
University of Wisconsin, Madison
Tiny Blue Dot Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score: Psilocybin Awake versus Asleep | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Awake versus Asleep | Baseline 2 (Day 0) to post-dosing Day 29 | BEAQ is 15-item survey scored on a 6 point likert scale. The total range is scores if from 15 to 90 where higher scores indicating greater avoidance. Reported here for psilocybin administered while awake to psilocybin administered while asleep. |
| Change in Brief Experiential Avoidance Questionnaire (BEAQ): Psilocybin Asleep versus Placebo Asleep | Baseline 2 (Day 0) to post-dosing Day 29 | BEAQ is 15-item survey scored on a 6 point likert scale. The total range is scores if from 15 to 90 where higher scores indicating greater avoidance. Reported here for psilocybin administered while asleep to placebo administered while asleep. |
| Change in Watts Social Connectedness (WCS) Scale: Psilocybin Awake versus Asleep | Baseline 2 (Day 0) to post-dosing Day 29 | WCS is a 19-item survey scored on a visual analog scale. Scores are reported from 0-100 where higher scores interpreted to be more connectedness to others. Reported here for psilocybin administered while awake to psilocybin administered while asleep. |
| Change in Watts Social Connectedness (WCS) Scale: Psilocybin Asleep versus Placebo Asleep | Baseline 2 (Day 0) to post-dosing Day 29 | WCS is a 19-item survey scored on a visual analog scale. Scores are reported from 0-100 where higher scores interpreted to be more connectedness to others. Reported here for psilocybin administered while asleep to placebo administered while asleep. |
| Persisting Effects Questionnaire (PEQ): Psilocybin Awake versus Asleep | post-dosing Day 29 | PEQ-15 is a 15-item survey in which initial items are rated on an 8-point scale ranging from "no more than routine, everyday experiences" to "the single most meaningful experience of my life." Remaining items are rated on a 7-point scale ranging from strong negative change to strong positive change. Higher scores indicate more positive persisting effects. Reported here for psilocybin administered while asleep to psilocybin administered while asleep. |
| Persisting Effects Questionnaire (PEQ): Psilocybin Asleep versus Placebo Asleep | post-dosing Day 29 | PEQ-15 is a 15-item survey in which initial items are rated on an 8-point scale ranging from "no more than routine, everyday experiences" to "the single most meaningful experience of my life." Remaining items are rated on a 7-point scale ranging from strong negative change to strong positive change. Higher scores indicate more positive persisting effects. Reported here for psilocybin administered while asleep to psilocybin administered while asleep. |
Countries
United States
Contacts
CONTACTCoPEWell Study Contact
PRINCIPAL_INVESTIGATORCharles Raison, MD
University of Wisconsin, Madison
Outcome results
None listed