Psilocybin-Induced Psychedelic Experiences During Sleep

(CoPE Pilot Trial)

Overseen by Charles Raison, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.

Research Team

Charles Raison, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for medically healthy, English-speaking individuals. It's not suitable for those on medications that interact with psilocybin, have sleep disorders like insomnia or apnea, are pregnant women at any point during the study, or have a history of heart transplant or stroke.

Inclusion Criteria

English-speaking

Live within 150 miles of Madison, WI for duration of study

Medically healthy

Exclusion Criteria

I am not pregnant.

I have a heart valve problem.

I have a sleep disorder such as insomnia, sleep apnea, restless legs syndrome, or narcolepsy.

Treatment Details

Interventions

• Psilocybin (Psychedelic)
• Saline (Other)

Trial Overview The study tests intravenous (IV) psilocybin administration in sleeping participants to find a dose that doesn't wake them and to see if it induces psychedelic experiences. A saline solution is used as a comparison.

Participant Groups

Group I: Initial Groups 1A and 2A Experimental Treatment 2 Interventions

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.

Group II: Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants Experimental Treatment 2 Interventions

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.

Group III: Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants Experimental Treatment 3 Interventions

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.

Group IV: Group 1B: 2-minute IV Psilocybin+Clonidine Infusion in Awake Participants Experimental Treatment 2 Interventions

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.

Group V: Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants Experimental Treatment 3 Interventions

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.

Group VI: Group 2C: 10-minute IV Psilocybin Alone in Awake Participants Active Control 1 Intervention

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.

Group VII: Group 1C: 2-minute IV Psilocybin Alone in Awake Participants Active Control 1 Intervention

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.

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+

Usona Institute

Collaborator

Trials

18

Recruited

1,100+

Tiny Blue Dot Foundation

Collaborator

Trials

9

Recruited

640+