Yale University
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.
This is a double-blind, placebo-controlled, crossover study, with two sub-studies each focusing on different routes of THC administration. Oral THC Sub-Study: 20 men and women aged 65 years or older, will be randomized to two doses of oral THC (5 mg and 10 mg). Across three, 8-hour test sessions, participants will receive a random sequence of 3 conditions: 5 mg oral THC; 10 mg oral THC; oral placebo. Vaporized THC Sub-Study: 20 men and women aged 65 years or older will be randomized to two doses of vaporized THC (2 mg and 4 mg). Across three 8-hour test sessions, participants will receive a…
Inclusion Criteria: 1. Healthy male and female participants aged 65 ≥ years old 2. Prior exposure to THC or cannabis least once in the last 10 years; 1-10 times in the last 20 years; or more than 20 times in their lifetime 3. Capable of providing informed consent in English. Exclusion Criteria: 1. Meeting DSM-5 criteria for psychiatric/substance use disorders (SUD) other than tobacco use disorder, within the last year 2. Current use of cannabinoid products, as evidenced by a urine drug screen 3. Having a history of treatment for cannabis use disorder 4. History of intent or current intent o…
Dronabinol 5 mg
Dronabinol 10mg
2mg Purified THC in an ethanolic solution
4mg Purified THC in an ethanolic solution
Oral placebo and/or vaporized saline
Arctuva estimate
Verify or correct the compensation shown for this listing.