Not Yet RecruitingPhase 1psilocybin
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
Sponsored by Johns Hopkins University
NCT ID
NCT07877987
Target Enrollment
80 participants
Start Date
2027-03-01
Est. Completion
2030-06-30
About This Study
This study will evaluate the subjective and behavioral effects of psilocybin relative to placebo and alcohol.
Conditions Studied
Interventions
- •0mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- •1mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- •5mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- •15mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- •25mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
- •0mg Psilocybin Capsule + 0.08% BAC Alcoholic Drink
Eligibility
Age:21 Years - N/A
Healthy Volunteers:Yes
View full eligibility criteria
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).
Study Locations (1)
Johns Hopkins University
Baltimore, Maryland, United States