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PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Sponsor: Yale University
Summary
The overarching goal of this double-blind, placebo-controlled, crossover study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of the main analgesic and psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), among older adults - the fastest growing population of cannabis consumers, and the most likely age cohort to use cannabinoids to relieve pain. This protocol includes two sub-studies, each randomizing 20 men and women aged 65 years or older to receive two administration routes of THC; oral administration and vaporized administration.
Official title: Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-10-17
Completion Date
2026-08-31
Last Updated
2026-02-23
Healthy Volunteers
Yes
Interventions
Dronabinol 5 MG
Dronabinol 5 mg
Dronabinol 10 MG
Dronabinol 10mg
2mg Purified THC in an ethanolic solution
2mg Purified THC in an ethanolic solution
4mg Purified THC in an ethanolic solution
4mg Purified THC in an ethanolic solution
Placebo
Oral placebo and/or vaporized saline
Locations (1)
VA Connecticut Healthcare System
West Haven, Connecticut, United States