NCT05602649

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Cannabis	Cannabis will be orally ingested
DRUG	Placebo	Placebo will be orally ingested

Timeline

• Start date: 2024-07-10
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-11-02
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study