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

NCT ID: NCT05602649

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2027-01-31

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.

Detailed 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.

Conditions

Cannabis Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo Gummy

Participants will self-administer a gummy containing 0mg THC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be orally ingested

Low Dose Gummy

Participants will self-administer a gummy containing 10mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

High Dose Gummy

Participants will self-administer a gummy containing 25mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

Placebo Chocolate

Participants will self-administer chocolate containing 0mg THC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be orally ingested

Low Dose Chocolate

Participants will self-administer chocolate containing 10mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

High Dose Chocolate

Participants will self-administer chocolate containing 25mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

Placebo Beverage

Participants will self-administer a beverage containing 0mg THC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be orally ingested

Low Dose Beverage

Participants will self-administer a beverage containing 10mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

High Dose Beverage

Participants will self-administer a beverage containing 25mg THC

Group Type: EXPERIMENTAL

Cannabis

Intervention Type: DRUG

Cannabis will be orally ingested

Interventions

Cannabis

Cannabis will be orally ingested

Intervention Type: DRUG

Placebo

Placebo will be orally ingested

Intervention Type: DRUG

Other Intervention Names

marijuana

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tory Spindle, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tory Spindle, PhD

Role: CONTACT

tspindle@jhmi.edu

410-550-0529

Lindsay Howard

Role: CONTACT

lhowar29@jhmi.edu

410-550-0009

Facility Contacts

Tory Spindle, PhD

Role: primary

tspindle@jhmi.edu

410-550-0529

Other Identifiers

1R01DA057201-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00354926

Identifier Type: -

Identifier Source: org_study_id