Examining how different cannabis edibles affect the body and mind
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
This study tests how different cannabis edibles like chocolates, gummies, and drinks affect the body and mind of healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05602649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21 to 55 with prior experience using THC-dominant cannabis.
Not a fit: Patients who have a history of significant allergic reactions or recent use of illicit drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how different formulations of cannabis edibles affect their absorption and effects, potentially guiding safer and more effective use.
How similar studies have performed: Other studies have explored the effects of cannabis edibles, but this specific investigation into the pharmacokinetics and pharmacodynamics of different formulations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.