Consciousness, Psilocybin, and Well-Being

NCT ID: NCT05592379

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2025-02-19

Brief Summary

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

Detailed Description

The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.

This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.

The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.

Adaptive Study Design Change per Protocol Amendment Approved 5/21/24

Conditions

Healthy; Psychedelic Experiences; Sleep

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Group 1A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants

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 Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Clonidine

Intervention Type: DRUG

Clonidine will be administered orally in a 0.2mg dose

Saline

Intervention Type: OTHER

The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.

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

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 Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Clonidine

Intervention Type: DRUG

Clonidine will be administered orally in a 0.2mg dose

Group 2A: 2-minute IV Psilocybin+Clonidine / Saline in Asleep Participants

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 Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Clonidine

Intervention Type: DRUG

Clonidine will be administered orally in a 0.2mg dose

Saline

Intervention Type: OTHER

The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.

Group 2B: 10-minute IV Psilocybin+Clonidine in Awake Participants

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 Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Clonidine

Intervention Type: DRUG

Clonidine will be administered orally in a 0.2mg dose

Group 1C: 2-minute IV Psilocybin Alone in Awake Participants

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.

Group Type: ACTIVE_COMPARATOR

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Group 2C: 10-minute IV Psilocybin Alone in Awake Participants

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 Type: ACTIVE_COMPARATOR

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Initial Groups 1A and 2A

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 Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Saline

Intervention Type: OTHER

The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.

Interventions

Psilocybin

The IV formulation of psilocybin will be prepared using bulk psilocybin that will satisfy Good Manufacturing Practice (GMP) criteria. The IV psilocybin solution will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center (PRC).

Intervention Type: DRUG

Clonidine

Clonidine will be administered orally in a 0.2mg dose

Intervention Type: DRUG

Saline

The IV placebo (saline) will be prepared under sterile conditions by the University of Wisconsin Pharmaceutical Research Center.

Intervention Type: OTHER

Other Intervention Names

Psilocybine; Psilocibin; Placebo

Eligibility Criteria

Inclusion Criteria

• Medically healthy
• English-speaking
• Live within 150 miles of Madison, WI for duration of study

Exclusion Criteria

• Current use of medications that may interact with psilocybin
• Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
• Females with positive urine pregnancy at any time point during screening or study participation
• Current cardiac valve disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Usona Institute

OTHER

Sponsor Role: collaborator

Tiny Blue Dot Foundation

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Raison, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A532017

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/2/2024

Identifier Type: OTHER

Identifier Source: secondary_id

233897

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0746

Identifier Type: -

Identifier Source: org_study_id