Health Trials

The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles

ConditionCannabis Use
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorJohns Hopkins University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cannabis
  • Placebo

Treatment groups

80 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov