PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

Description

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. The research will proceed with a sub-study, randomizing 20 men and women aged 65 years or older, to two doses focusing on oral THC administration and a sub-study randomizing 20 men and women aged 65 years or older, to two doses focusing on vaporized THC administration.

Conditions

Pain, Tolerance, Oral vs Vaporized THC, Abuse Liability

Study Overview

Study Details

Study overview

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. The research will proceed with a sub-study, randomizing 20 men and women aged 65 years or older, to two doses focusing on oral THC administration and a sub-study randomizing 20 men and women aged 65 years or older, to two doses focusing on vaporized THC administration.

Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

Condition
Pain, Tolerance
Intervention / Treatment

-

Contacts and Locations

West Haven

VA Connecticut Healthcare System, West Haven, Connecticut, United States, 06516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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 of abstaining from cannabis use
  • 5. Clinically significant medical disorders (e.g. liver/kidney dysfunction, immunosuppressing conditions, history or presence of epilepsy, seizures, head trauma with loss of consciousness)
  • 6. Medical conditions that increase the risk of respiratory problems (e.g. COPD, asthma, recuring bronchitis, reactive airway disorder)\* (does not apply to the Oral THC Sub-Study)
  • 7. History of environmental sensitivities (e.g. bronchospastic allergies, multiple chemical sensitivities) or other airway sensitivities that require the use of an epi pen\*(does not apply to the Oral THC Sub-Study)
  • 8. Neurological conditions that may change the response to nociceptive stimuli (e.g., stroke, neuropathy), or that lead to loss of balance, evidenced by a neuro-sensory exam
  • 9. Contraindications for exposure to nociceptive stimuli, such as untreated hypertension
  • 10. Current regular use of drugs known to affect pain, or that are prominent inducers or inhibitors of CYP2C9, CYP3A4, or UGTA19 (e.g., carbamazepine, valproate, fluvoxamine, and paroxetine)
  • 11. Major neurocognitive disorders precluding participation, evidenced by a clinical exam
  • 12. Abnormal EKG, arrythmia, vasospastic disease, chronic heart failure, or presence of a pacemaker
  • 13. Elevation of liver enzymes (ALT, AST) 2x the normal limit or higher
  • 14. Personal or family history of primary psychotic disorders, or mood disorders with psychotic features
  • 15. Current suicidal ideation
  • 16. Allergy or serious adverse reactions to sesame oil, THC, or cannabis
  • 17. Having received any drug as part of a research study within 30 days prior to receiving the study medication in the current study.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Joao P. De Aquino, M.D., PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

2025-08-31