Exploring how psilocybin and its administration context affect mental well-being in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves 120 healthy participants aged 21 to 70 who experience moderate to lower-than-average mental well-being. Participants will be randomly assigned to receive either a placebo or an oral dose of psilocybin (up to 25mg) in one of two different contextual settings. The aim is to evaluate how these contextual factors, referred to as 'set and setting', influence the psychological effects of psilocybin. The study employs a double-blind, randomized design to assess changes in mental well-being over a four-week period following the dosing session.

Why it matters

Who can join: the full rules

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 it's running

• UCSF Mission Bay
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Robin Carhart-Harris, PhD — University of California, San Francisco
• Study coordinator: Hannes Kettner, MSc
• Email: setandsetting@ucsf.edu
• Phone: 4158495452

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guiding Optimal Blood Pressure in Peritoneal Dialysis

  This pilot tests whether aiming for a lower systolic blood pressure target (<120 mmHg) is feasible and practical for adults with end-stage kidney disease on peritoneal dialysis, compared to a <140 mmHg target.

  Recruiting at 2 sites University of California, San Francisco · San Francisco, California and 2 other locations · NCT07910773

• Understanding how the orbitofrontal cortex guides approach vs. avoidance in depression

  This study tests how different parts of the orbitofrontal cortex influence whether people pursue rewards or risk loss, and whether this pattern is altered in Major Depressive Disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07896343

• LIFU to Help Sleep and Amyloid Reduction in Older Adults with Cognitive Impairment

  A wearable ultrasound device (ATTN201) is being tested to see if it’s safe and easy to use for people 65 and older with mild cognitive impairment and amyloid buildup.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07866768

• Tics and Tourette's: Accelerated TBS rTMS in Teens and Adults

  This study tests whether a short, intensive course of inhibitory theta burst stimulation can help reduce tic symptoms in teens and young adults with Tourette syndrome or chronic tic disorders.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07839377

• Compare two bladder medicines and placebo for urgency incontinence in older women

  This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07829029

• Peer-led Dynamic Choice HIV Prevention for Women

  This trial tests a peer-led HIV prevention approach to see if it helps women at higher risk in Uganda better prevent HIV than standard care.

  Recruiting University of California, San Francisco · Kampala · NCT07787988

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.