NCT04283019

The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the pharmacokinetic and pharmacodynamic effects of oral Cannabidiol (with or without low levels of THC), under acute and chronic dosing conditions.

Detailed description

Participants (N=60), will be randomized to 1 of 3 oral dosing conditions that include: 100mg CBD/3.7mg THC (0.39% THC), 100mg CBD/2.8mg THC (0.3% THC), or 100mg CBD/0mg THC (0.0% THC). Participants will first complete an 8-hour drug administration session and after this initial session, participants will take participants' assigned study drug for the next 14 days at home, twice daily (participants will visit the lab on days 2, 7, and 14). Participants will return on day 21 (after 1 week washout) for a final visit. During the 8-hour session and visits occurring during the following 21 days, participants will provide biospecimens (urine, blood, oral fluid, hair) which will be tested for cannabinoid concentrations. Pharmacodynamic assessments (subjective and cognitive effects) will also be assessed during these visits.

Conditions

• Cannabis, Drug Effects

Interventions

Type	Name	Description
DRUG	CBD	CBD will be orally ingested
DRUG	THC	THC will be orally ingested

Timeline

• Start date: 2021-08-15
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2020-02-25
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study