Understanding brain and body reactions during psychedelic experiences
Multivariate Neural and Physiological Correlates of Psychedelic Sub-states: a Within-subjects, Healthy Volunteer Study with Experience-sampling
This study is testing how the brain and body react during psychedelic experiences using MRI scans on healthy volunteers who have tried psychedelics before.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05698511 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the mental states and physiological responses that occur during psychedelic experiences by using MRI scans on healthy volunteers. Participants will receive four doses of psilocybin, with a mix of low and high doses, while their brain and body reactions are monitored. The goal is to identify consistent neural and physiological correlates of these experiences, which could inform future therapeutic applications of psychedelics. Up to 12 healthy volunteers with prior psychedelic experience will be involved in this research.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21 to 70 with prior experiences using psychedelic substances.
Not a fit: Patients who have not previously used psychedelics or those with significant mental or physical health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of psychedelics and their potential therapeutic effects.
How similar studies have performed: Other studies have shown promising results in understanding the effects of psychedelics, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have had previous experiences with psychedelic substances * Mentally and physically healthy * Have had prior experiences with MRI machines (optional but preferred) * Flexible schedule- able to commit to scans once or twice per week for 4 weeks in a row * Are between 21 and 70 years of age * Are fluent in speaking and reading English * Can swallow pills/capsules * 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 and contraception over the course of the study. Adequate forms of birth control or contraception 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). Not of childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and/or tubal ligation), permanently sterile by medical device such as Essure, postmenopausal, or male by birth. Contraception applies to males as well as females and male participants must not be planning sperm donation within the study period. * Able and willing to provide informed consent * Able and willing to use computers and tablets or phones to enter electronic data * Agree to inform the investigators within 48 hours of any new or changed medical conditions.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Robin Carhart-Harris, PhD — University of California, San Francisco
- Study coordinator: Robin Carhart-Harris, PhD
- Email: insight2@ucsf.edu
- Phone: (415) 476-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.