Actively Recruiting
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Led by Johns Hopkins University · Updated on 2026-04-13
80
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
T
Tory Spindle, PhD
CONTACT
L
Lindsay Howard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
9
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