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

Psilocybin Intoxication

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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Carlos A Zamarripa, PhD
CONTACT
410-550-6969czamarr2@jhmi.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source