The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
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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.
Full description
The purpose of this study is to examine the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 popular types of cannabis edibles: THC-infused chocolates, gummies, and drinks. This study will utilize a rigorous double-blind, placebo-controlled, within-subjects design. Healthy adults (N=40; 20 males, 20 females) will complete 9 outpatient drug administration sessions in a randomized order. After 8 hours of monitored fasting, participants will consume 1 of 3 types of edibles (chocolates, gummies, or drinks) that are representative of current retail cannabis products. Products will contain 0 (placebo), 10, or 25mg THC. PD assessments include a battery of cognitive/psychomotor performance tasks shown to be sensitive to oral cannabis at these doses and subjective drug effects. Blood samples will be drawn to measure THC and its primary metabolites. Vital signs will be recorded. These procedures will be completed during each of the 9 study sessions.
Enrollment
Sex
Ages
Volunteers
Inclusion and 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 9 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Tory Spindle, PhD; Lindsay Howard
Data sourced from clinicaltrials.gov
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