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

Launched by JOHNS HOPKINS UNIVERSITY · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of cannabis edibles, like chocolates, gummies, and drinks, affect the body after consumption. Specifically, it will study how a key ingredient called delta-9-tetrahydrocannabinol (THC) is absorbed and how it works in the body. The trial will involve 40 healthy adults who will participate in nine different sessions. Each session will require an overnight stay, during which participants will eat the THC-infused products while fasting. After consuming the products, they will complete various tasks to assess their thinking and motor skills, have their blood taken, and have their vital signs checked.

To be eligible for this study, participants must be between 21 and 55 years old, in good health, and have some previous experience using THC products. They should not be pregnant or nursing and must pass tests to ensure they are not using any illicit drugs or alcohol. Throughout the study, participants can expect to engage in both assessments and monitoring to help researchers understand how these cannabis edibles affect their bodies. This trial is currently recruiting participants, and it's an important step in learning more about the effects of cannabis in different forms.

Gender

ALL

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.