Psilocybin for Mental Health

Overseen By Michele Gassman, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Psychotropic, CNS-altering

Disqualifiers: Psychiatric diagnosis, Hypertension, others

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Charles Raison, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

The CoPEWell study is for individuals interested in exploring the effects of psilocybin on mood and well-being. Participants should be willing to potentially experience psychedelic states or receive treatment while asleep, over a period of up to 4 months.

Inclusion Criteria

No exclusionary sleep condition

I am physically healthy with no major medical conditions.

English-speaking (able to provide consent and complete questionnaires)

Exclusion Criteria

Clinically significant electrocardiogram (ECG)

Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)

I do not have any medical or sleep conditions that would exclude me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin or placebo by intravenous infusion while awake or asleep during an overnight dosing visit

4 weeks

1 overnight visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Long-term follow-up

Participants are assessed for persisting effects of psilocybin on wellbeing and social connectedness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview

This trial investigates if improvements in mood from psilocybin are due to the 'trip' or direct brain effects. It involves giving participants psilocybin under different conditions (awake/asleep) and comparing results with those given clonidine or a saline placebo.

How Is the Trial Designed?

Group I: Psilocybin While Awake, Placebo While Asleep Experimental Treatment 3 Interventions

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.

Group II: Placebo While Awake, Psilocybin While Asleep Experimental Treatment 3 Interventions

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.

Group III: Placebo While Awake, Placebo While Asleep Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Tiny Blue Dot Foundation

Collaborator

Trials

10

Recruited

660+