What this study is
This study will evaluate the subjective and behavioral effects of psilocybin relative to placebo and alcohol.
What's being tested
- 0mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 0mg psilocybin and a drink that contains alcohol dosed to 0.00% BAC.
- 1mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 1mg psilocybin and a drink that contains alcohol dosed to 0.00% BAC.
- 5mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 5mg psilocybin and a drink that contains alcohol dosed to 0.00% BAC.
- 15mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 15mg psilocybin and a drink that contains alcohol dosed to 0.00% BAC.
- 25mg Psilocybin Capsule + 0.00% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 25mg psilocybin and a drink that contains alcohol dosed to 0.00% BAC.
- 0mg Psilocybin Capsule + 0.08% BAC Alcoholic Drink
Intervention · DRUG
Participants will self-administer a capsule containing 0mg psilocybin and a drink that contains alcohol dosed to 0.08% BAC.
Study details
- Sponsor
- Johns Hopkins University
- Conditions
- Psilocybin Intoxication
- Enrolling
- 80 people
- Starts
- 2027-03-01
- Est. completion
- 2030-06-30
- Design
- Quadruple-blind, randomized, crossover, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJohns Hopkins University
Baltimore, Maryland, United States
- Carlos A Zamarripa, PhD · Contact410-550-6969czamarr2@jhmi.edu
Study team
Sponsor
Johns Hopkins University
Study ID IRB00527146
Principal investigator
Carlos A Zamarripa, PhD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.