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

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University

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.