The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Trial Parameters
Brief 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.
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