PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
Healthy male and female participants aged 65 ≥ years old
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
Capable of providing informed consent in English.
Disqualifiers
Meeting DSM-5 criteria for psychiatric/substance use disorders (SUD) other than tobacco use disorder, within the last year
Current use of cannabinoid products, as evidenced by a urine drug screen
Having a history of treatment for cannabis use disorder
History of intent or current intent of abstaining from cannabis use
Trial design
Treatments tested in this trial
- Dronabinol 5 MG
- Dronabinol 10 MG
- 2mg Purified THC in an ethanolic solution
- 4mg Purified THC in an ethanolic solution
- Placebo
Treatment groups
20 Participants
are divided into 5 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
VA Connecticut Healthcare System
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov