RECRUITING

Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers

Conditions

Healthy Participants with Lower-than-average Mental Well-being well-being psilocybin psychedelic neuroimaging healthy volunteers

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

One hundred twenty healthy participants, ages 21 to 70, who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms, using a 2x2 factorial design. Depending on the study arm, participants will either receive an inactive placebo or up to 25mg psilocybin (oral dose), in one of two set and setting conditions; drug administration contexts that are predicted to modulate drug effects. The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context (set and setting).

Official Title

2 X 2 Factorial, Double-blind, Randomized Trial of 'set and Setting': a Translational Study in Healthy Volunteers

Quick Facts

Study Start:2024-10-20

Study Completion:2028-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06626139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Are between 21 and 70 years of age 2. Are fluent in speaking and reading English 3. Are able to swallow pills/capsules 4. If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must agree to an adequate form of birth control over the course of the study. Adequate forms of birth control include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Unable to become pregnant is defined as documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and/or tubal ligation), permanently sterile by medical device such as Essure, postmenopausal, or assigned male sex at birth. 5. Able and willing to provide informed consent 6. Able and willing to use computers and tablets or phones to enter electronic data 7. Agree to inform the investigators within 48 hours of any new or changed medical conditions. 8. Have an identified support person 9. For those dosed with psilocybin, their prior consent to be accompanied home (or to an otherwise safe destination) by a support person, chosen by them - ahead of time, or by a member of the study team. 10. Willing to provide contact details for a friend or family member, should there be an inability to make direct contact with the participant	1. Have a current diagnosed psychiatric disorder that, in the opinion of the study clinician or PI, renders to person psychologically unstable or unduly vulnerable, or interferes with activities of daily living, or could impact attendance at or participation in study activities 2. Have a current or previously diagnosed psychotic disorder or bipolar disorder 3. Have a previously diagnosed psychiatric disorder that renders the person unsuitable for the study (e.g., personality disorder) 4. Have one or more immediate family members with a current or previously diagnosed psychotic disorder (such as schizophrenia) or bipolar disorder 5. Have a medically significant condition that renders the person unsuitable for the study (e.g., cardiovascular or cerebrovascular conditions for which an acute increase in blood pressure would be clinically concerning, hepatic or renal disease, etc.) 6. Have a history of suicidal ideation or attempted suicide in the past year that, in the opinion of the study clinician or PI, may present a risk of suicidal or self-injurious behavior 7. Have a wellbeing score on the WHO-5 higher than 65 points 8. Have used a moderate-to-high dose of a psychedelic substance on more than 10 occasions in the past five years and/or have used a moderate-to-high dose of a psychedelic within the last 6 months. 9. Give a positive alcohol breathalyzer test result on any study visit 10. Have used cocaine, stimulants (other than nicotine and caffeine), amphetamines, cannabis, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 7 days of an Experimental Session 11. A positive urine drug screen to any of the above prior to an Experimental Session, which warrants exclusion based on concerns that it may compromise safety or confound outcomes 12. Are currently taking any of the medications or substances listed in Appendix 1 or, in the opinion of the study clinician or PI, engage in excessive use of alcohol or drugs of abuse 13. Are breastfeeding, or have a positive pregnancy test at screening or at any point during the course of the study 14. Have a recent history of suicidal ideation or attempted suicide (ahead of dosing session), as assessed through the screening interview and specifically with the C-SSRS and/or PHQ-9 15. Systolic and diastolic BP values exceeding 139 SBP and exceeding 89 DBP and heart rate exceeding 90 bpm would result in exclusion from the study. 16. Present with a exceeding 450 msec or with evidence of cardiac damage, ischemia, or heart disease. 17. Have received an investigational drug within 30 days of the screening visit 18. Have an allergy or intolerance to any of the materials contained in either drug product or setting components, such as certain scents. 19. Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as determined by an MRI contraindications questionnaire. 20. Are using any dietary supplements or drugs with potentially concerning drug-drug interaction (e.g., SSRIs, MAO-Is, TCAs, lithium, serotonin-acting dietary supplements such as St. John's wort) 21. Have any current problem which, in the opinion of the investigator or clinician, might interfere with participation.

Inclusion Criteria

Exclusion Criteria

1. Are between 21 and 70 years of age
2. Are fluent in speaking and reading English
3. Are able to swallow pills/capsules
4. If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must agree to an adequate form of birth control over the course of the study. Adequate forms of birth control include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Unable to become pregnant is defined as documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and/or tubal ligation), permanently sterile by medical device such as Essure, postmenopausal, or assigned male sex at birth.
5. Able and willing to provide informed consent
6. Able and willing to use computers and tablets or phones to enter electronic data
7. Agree to inform the investigators within 48 hours of any new or changed medical conditions.
8. Have an identified support person
9. For those dosed with psilocybin, their prior consent to be accompanied home (or to an otherwise safe destination) by a support person, chosen by them - ahead of time, or by a member of the study team.
10. Willing to provide contact details for a friend or family member, should there be an inability to make direct contact with the participant

1. Have a current diagnosed psychiatric disorder that, in the opinion of the study clinician or PI, renders to person psychologically unstable or unduly vulnerable, or interferes with activities of daily living, or could impact attendance at or participation in study activities
2. Have a current or previously diagnosed psychotic disorder or bipolar disorder
3. Have a previously diagnosed psychiatric disorder that renders the person unsuitable for the study (e.g., personality disorder)
4. Have one or more immediate family members with a current or previously diagnosed psychotic disorder (such as schizophrenia) or bipolar disorder
5. Have a medically significant condition that renders the person unsuitable for the study (e.g., cardiovascular or cerebrovascular conditions for which an acute increase in blood pressure would be clinically concerning, hepatic or renal disease, etc.)
6. Have a history of suicidal ideation or attempted suicide in the past year that, in the opinion of the study clinician or PI, may present a risk of suicidal or self-injurious behavior
7. Have a wellbeing score on the WHO-5 higher than 65 points
8. Have used a moderate-to-high dose of a psychedelic substance on more than 10 occasions in the past five years and/or have used a moderate-to-high dose of a psychedelic within the last 6 months.
9. Give a positive alcohol breathalyzer test result on any study visit
10. Have used cocaine, stimulants (other than nicotine and caffeine), amphetamines, cannabis, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 7 days of an Experimental Session
11. A positive urine drug screen to any of the above prior to an Experimental Session, which warrants exclusion based on concerns that it may compromise safety or confound outcomes
12. Are currently taking any of the medications or substances listed in Appendix 1 or, in the opinion of the study clinician or PI, engage in excessive use of alcohol or drugs of abuse
13. Are breastfeeding, or have a positive pregnancy test at screening or at any point during the course of the study
14. Have a recent history of suicidal ideation or attempted suicide (ahead of dosing session), as assessed through the screening interview and specifically with the C-SSRS and/or PHQ-9
15. Systolic and diastolic BP values exceeding 139 SBP and exceeding 89 DBP and heart rate exceeding 90 bpm would result in exclusion from the study.
16. Present with a exceeding 450 msec or with evidence of cardiac damage, ischemia, or heart disease.
17. Have received an investigational drug within 30 days of the screening visit
18. Have an allergy or intolerance to any of the materials contained in either drug product or setting components, such as certain scents.
19. Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as determined by an MRI contraindications questionnaire.
20. Are using any dietary supplements or drugs with potentially concerning drug-drug interaction (e.g., SSRIs, MAO-Is, TCAs, lithium, serotonin-acting dietary supplements such as St. John's wort)
21. Have any current problem which, in the opinion of the investigator or clinician, might interfere with participation.

Contacts and Locations

Study Contact

Hannes Kettner, MSc

CONTACT

4158495452

setandsetting@ucsf.edu

Avery Ostrand, MSc

CONTACT

avery.ostrand@ucsf.edu

Principal Investigator

Robin Carhart-Harris, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jennifer Mitchell, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

UCSF Mission Bay

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: Robin Carhart-Harris, PhD, MA

Robin Carhart-Harris, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Jennifer Mitchell, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-20

Study Completion Date2028-11-30

Study Record Updates

Study Start Date2024-10-20

Study Completion Date2028-11-30

Terms related to this study

Keywords Provided by Researchers

well-being
psilocybin
psychedelic
neuroimaging
healthy volunteers

Additional Relevant MeSH Terms

Healthy Participants with Lower-than-average Mental Well-being