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The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

RecruitingPhase 1Healthy volunteers welcome

Who can join

Ages 21 to 55 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.

About the study

This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.

What is being tested

Sponsor: Johns Hopkins University · Participants: 80 · Started: Jul 10, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05602649

Locations in the U.S.

MarylandJohns Hopkins Behavioral Pharmacology Research Unit, Baltimore

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.