Safety for Home Administration of Microdose Psilocybin Use

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06450210
Phase
PHASE1
Status
Recruiting
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Conditions

  • Psychedelic Experiences

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • psilocybin trihydrate — DRUG
    Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).
  • Placebo — DRUG
    Participants will receive a capsule identical in appearance to the active drug that contains an inactive substance.

Study Details

The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants. Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments.

Key Dates

Start date
Dec 6, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 1.2 mg psilocybin trihydrate microdose
    Participants will receive a single microdose of 1.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.
  • Experimental: 2.0 mg psilocybin trihydrate microdose
    Participants will receive a single microdose of 2.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.
  • Experimental: 3.0 mg psilocybin trihydrate microdose
    Participants will receive a single microdose of 3.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.
  • Experimental: 4.2 mg psilocybin trihydrate microdose
    Participants will receive a single microdose of 4.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.
  • Placebo Comparator: Placebo
    Participants will receive a single placebo oral capsule in the laboratory in double-blind fashion.

Primary Outcome Measure

Systolic and Diastolic Blood pressure (mmHg) [ Time Frame: Baseline, 1-4 hours post dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
5510 Nathan Shock DriveBaltimoreMaryland21224
Matthew H Nielsen Dick, BA
[email protected]
410-999-8066

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5510 Nathan Shock Drive· Baltimore, MD

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