Actively Recruiting
Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers
Led by Robin Carhart-Harris, PhD, MA · Updated on 2025-03-27
120
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 21 and 70 years of age
- Be fluent in speaking and reading English
- Be able to swallow pills or capsules
- If able to become pregnant, be non-lactating, have a negative pregnancy test at study entry and before each session, and agree to use adequate birth control methods
- Be able and willing to provide informed consent
- Be able and willing to use computers or mobile devices to enter electronic data
- Agree to inform investigators within 48 hours of any new or changed medical conditions
- Have an identified support person
- For those receiving psilocybin, consent to be accompanied home by a support person or study team member
- Willing to provide contact information for a friend or family member in case of inability to contact participant
You will not qualify if you...
- Have a current diagnosed psychiatric disorder that causes psychological instability, vulnerability, or interferes with daily living or study participation
- Have a medically significant condition that makes participation unsuitable
- Test positive for alcohol on any study visit
- Test positive for excluded substances on urine drug screen before experimental sessions
- Are breastfeeding or have a positive pregnancy test at screening or during the study
- Have blood pressure above 139/89 mmHg or heart rate above 90 bpm
- Have a prolonged QT interval over 450 msec or evidence of cardiac damage, ischemia, or heart disease
- Have received an investigational drug within 30 days before screening
- Have allergies or intolerance to any study drug or setting materials such as certain scents
- Have MRI contraindications such as metal implants, pacemakers, or claustrophobia
- Have any current problem that might interfere with participation according to investigators or clinicians
AI-Screening
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Trial Site Locations
Total: 1 location
1
UCSF Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
H
Hannes Kettner, MSc
CONTACT
A
Avery Ostrand, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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