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Not yet recruitingPhase 1

The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin

NCT07877987 · Johns Hopkins University

Closed to entry
Status
Not accepting participants
Phase 1
Phase
80
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study will evaluate the subjective and behavioral effects of psilocybin relative to placebo and alcohol.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Driving performance as assessed by standard deviation of lateral position (SDLP)

    Measured over Baseline, 1, 3, 6, and 24 hours post-dosing

  • Driving performance as assessed by global drive score during the simulated driving task

    Measured over Baseline, 1, 3, 6, and 24 hours post-dosing

  • Total Clues and Cues exhibited during Standardized Field Sobriety Tests (SFSTs)

    Measured over Baseline, 1, 3, 6, and 24 hours post-dosing.

  • Drug Effect Questionnaire (DEQ) - Feel Drug Effect

    Measured over Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing.

  • Drug Effect Questionnaire (DEQ) - Drug Liking

    Measured over Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing.

  • Drug Effect Questionnaire - Confidence to Drive

    Measured over Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing.

  • Whole Psilocin Concentrations - THC Concentrations

    Measured over Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 24 hours post-dosing.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Be at least 21 years old, * Be in good general health based on screening procedures (e.g., physical exam, blood testing, psychiatric evaluation), * Have vital signs in normal range, * Have not donated blood in past 30 days, * Not be pregnant (assessed via blood serum at screening and urinalysis before each study session) or breast feeding (women only), * Have a body mass index (BMI) in the range of 18 to 36 kg/m2, * Report using psilocybin at least once in the participant's lifetime, but not in the past month, * Negative urine test for illicit drug use (not including cannabis) and negative breath alcohol test (0% breath alcohol concentration) at screening and before study sessions. Exclusion Criteria: * Psychoactive drug use (aside from nicotine, alcohol, caffeine, cannabis) in past month, * Current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety, * History of or current evidence of significant medical condition that would impact participant's safety (e.g., hypertension, epilepsy), * Evidence of current psychiatric condition (based on MINI), * Family history of 1st degree relative with psychotic disorder or bipolar 1 disorder, * Clinical institute withdrawal assessment for alcohol-revised (CIWA-Ar) score \>9 (which indicates that severe withdrawal),50 * Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days, and * Shipley vocabulary score \<18 (corresponds to 5th grade reading level).

Where

1 study site

FacilityCityRegionCountry
Johns Hopkins UniversityBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07877987 on ClinicalTrials.gov →

Last updated in the registry 2026-10-16. Registry records change; this page reflects the data build of 2026-10-30.

Related

Where this trial sits