Clinical TrialHealthy VolunteersPsilocybinPsilocybinPlaceboPlaceboRecruiting

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

This double-blind, randomised, placebo-controlled trial (n=120) will investigate the interaction between psilocybin (up to 25 mg, oral) and the context of its administration in healthy volunteers with moderate-to-lower-than-average mental well-being.

Target Enrollment
120 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind between-subjects 2×2 factorial study (n=120) testing single oral dose psilocybin (up to 25 mg) versus inactive placebo crossed with two predefined contextual (set and setting) conditions.

Primary aims are to assess interaction effects on psychological well‑being (WEMWBS) at 4 weeks and connectedness (WCS); secondary acute-experience endpoints include Emotional Breakthrough Inventory and subfactors of the Challenging Experience Questionnaire.

Healthy volunteers with limited prior psychedelic experience will be randomised 1:1:1:1 into Psilocybin/Context1, Psilocybin/Context2, Placebo/Context1, or Placebo/Context2 with single dosing and follow-up assessments.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin C1

experimental

Single oral dose up to 25 mg psilocybin administered in Context 1.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Up to 25 mg per participant

  • Compound
    via Other• single session

    Context 1 behavioural condition

Psilocybin C2

experimental

Single oral dose up to 25 mg psilocybin administered in Context 2.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Up to 25 mg per participant

  • Compound
    via Other• single session

    Context 2 behavioural condition

Placebo C1

inactive

Single oral inactive placebo administered in Context 1.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Inactive placebo

  • Compound
    via Other• single session

    Context 1 behavioural condition

Placebo C2

inactive

Single oral inactive placebo administered in Context 2.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Inactive placebo

  • Compound
    via Other• single session

    Context 2 behavioural condition

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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. 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, 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

  • Exclusion Criteria:
  • 1. Have a current diagnosed psychiatric disorder that, in the opinion of the study clinician or PI, renders the person psychologically unstable or unduly vulnerable, 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 QTc 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

Study Details

Locations

UCSF Mission Bay — San Francisco, California, United States

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