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The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
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
- Cannabis (drug)
- Placebo (drug)
Sponsor: Johns Hopkins University · Participants: 80 · Started: Jul 10, 2024
Contact the study team
- Tory Spindle, PhD · Phone: 410-550-0529
- Lindsay Howard · Phone: 410-550-0009
Official record on ClinicalTrials.gov — NCT05602649
Locations in the U.S.
| Maryland | Johns 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.