Examining how different cannabis edibles affect the body and mind

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the pharmacokinetics and pharmacodynamics of THC-infused chocolates, gummies, and drinks in healthy adults. Participants will undergo nine drug administration sessions, consuming various THC products after fasting, while their cognitive and psychomotor performance, subjective effects, and vital signs are monitored. The study employs a double-blind, placebo-controlled, within-subjects design to ensure rigorous data collection and analysis. Blood samples will also be taken to measure THC levels and its metabolites.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Have provided written informed consent.
* Be between the ages of 21 and 55.
* Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
* Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
* Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at admission for each session.
* Have prior experience using THC-dominant cannabis.
* Have a body mass index (BMI) in the range of 16 to 38 kg/m2.
* Have not donated blood in the past 30 days.

Exclusion Criteria

* Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.
* History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
* Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.
* History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.
* Evidence of current psychiatric condition (based on MINI for DSM-5).
* Been in treatment previously for cannabis use disorder.
* Receiving of any drug as part of a research study within the past 30 days.
* History of epilepsy or other serious medical condition.

Where it's running

• Johns Hopkins Behavioral Pharmacology Research Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Tory Spindle, PhD — Johns Hopkins University
• Study coordinator: Tory Spindle, PhD
• Email: tspindle@jhmi.edu
• Phone: 410-550-0529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.