Actively Recruiting
PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Led by Yale University · Updated on 2026-02-23
20
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
V
VA Connecticut Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 65 years or older
- Prior exposure to THC or cannabis at 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
You will not qualify if you...
- Meeting DSM-5 criteria for psychiatric or substance use disorders (other than tobacco use disorder) within the last year
- Current use of cannabinoid products confirmed by urine drug screen
- History of treatment for cannabis use disorder
- Intent to abstain from cannabis use currently or in the past
- Clinically significant medical disorders such as liver or kidney dysfunction, immunosuppressing conditions, epilepsy, seizures, or head trauma with loss of consciousness
- Medical conditions increasing risk of respiratory problems (e.g., COPD, asthma, recurrent bronchitis, reactive airway disorder) (not applicable to oral THC sub-study)
- History of environmental or airway sensitivities requiring use of an epinephrine injector (not applicable to oral THC sub-study)
- Neurological conditions affecting pain response or balance, evidenced by neuro-sensory exam
- Contraindications for exposure to pain stimuli, such as untreated hypertension
- Regular use of drugs affecting pain or certain liver enzymes (CYP2C9, CYP3A4, UGTA19)
- Major neurocognitive disorders that prevent participation
- Abnormal heart rhythm, arrhythmia, vasospastic disease, chronic heart failure, or pacemaker
- Liver enzyme elevation two times or higher than normal
- Personal or family history of primary psychotic disorders or mood disorders with psychotic features
- Current suicidal ideation
- Allergy or serious reaction to sesame oil, THC, or cannabis
- Participation in another drug study within 30 days before this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
J
Julia Meyerovich, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
5
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