NCT05602649 The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
| NCT ID | NCT05602649 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Cannabis Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-07-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Tory Spindle, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05602649 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 55 Years, studying Cannabis Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05602649 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05602649 currently recruiting?
Yes, NCT05602649 is actively recruiting participants. Contact the research team at tspindle@jhmi.edu for enrollment information.
Where is the NCT05602649 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05602649 clinical trial?
NCT05602649 is sponsored by Johns Hopkins University. The principal investigator is Tory Spindle, PhD at Johns Hopkins University. The trial plans to enroll 80 participants.