Clinical TrialHealthy VolunteersPsilocybinActive not recruiting

Neural and Physiological Correlates of Psychedelic Sub-states (i2)

Open-label single-group study (n=12) giving four psilocybin doses (10 mg then three 25 mg sessions, ≥7 days apart) to healthy volunteers with repeated MRI to map brain and physiological correlates.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

The main purpose is to identify reliable brain and bodily reactions arising during the psychedelic experience by repeatedly scanning the same healthy volunteers under psilocybin.

Participants receive four dosing visits: first a 10 mg psilocybin session, then up to three 25 mg sessions at least seven days apart; each dosing visit includes multiple in-scanner runs during which brief valence ratings are collected every 100 seconds.

From screening through final follow-up participants are in the study for approximately 6–12 weeks, with a post-dose phone call the day after each dosing visit to assess wellbeing and experiences.

Study Protocol

Preparation

sessions

Dosing

4 sessions
45 min each

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Healthy volunteers receive up to four doses of psilocybin (10 mg first session, then up to three 25 mg sessions) separated by at least seven days; MRI scans performed during dosing visits.

Interventions

  • Psilocybin10 - 25 mg
    via Oral• four sessions• 4 doses total

    First session 10 mg; remaining three sessions 25 mg each; sessions ≥7 days apart; scans during dosing.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion 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.

Exclusion Criteria

No exclusion criteria listed.

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2023-02-01
    End: 2023-11-30
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

University of California, San Francisco — San Francisco, California, United States

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