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RecruitingPhase 2

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

NCT06626139 · SnS · Robin Carhart-Harris, PhD, MA

Recruiting
Status
Accepting participants
Phase 2
Phase
120
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Challenging Experience Questionnaire (CEQ) subscales score

    Measured over Eight hours post-dose.

  • Change in Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) score from Baseline to 28 days post-dose

    Measured over Baseline to 28 days post-dose.

  • Change in Watts Connectedness Scale (WCS) scores from Baseline to 28 days post-dose

    Measured over Baseline to 28 days post-dose.

  • Emotional Breakthrough Inventory (EBI) score

    Measured over Eight hours post-dose.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
If you are interested in participating in this study, please follow this link to check your eligibility: https://tiny.ucsf.edu/setsettingscreener Inclusion Criteria: Participants will be considered for inclusion if they: 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 Exclusion Criteria: Participants will be excluded if they: 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 medically significant condition that renders the person unsuitable for the study 3. Give a positive alcohol breathalyzer test result on any study visit 4. A positive urine drug screen to any excluded substances prior to an Experimental Session, which warrants exclusion based on concerns that it may compromise safety or confound outcomes 5. Are breastfeeding, or have a positive pregnancy test at screening or at any point during the course of the study 6. 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. 7. Present with a exceeding 450 msec or with evidence of cardiac damage, ischemia, or heart disease. 8. Have received an investigational drug within 30 days of the screening visit 9. Have an allergy or intolerance to any of the materials contained in either drug product or setting components, such as certain scents. 10. Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) 11. Have any current problem which, in the opinion of the investigator or clinician, might interfere with participation.

Where

1 study site

FacilityCityRegionCountry
UCSF Mission BaySan FranciscoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06626139 on ClinicalTrials.gov →

Last updated in the registry 2026-06-04. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits