The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Johns Hopkins University
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.
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 (pl…
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- Yes
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-do…
Interventions
- DrugCannabis
Cannabis will be orally ingested
- DrugPlacebo
Placebo will be orally ingested
Location
- Johns Hopkins Behavioral Pharmacology Research UnitBaltimore, Maryland