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RecruitingEarly Phase 1NCT05906511

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

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

Sponsor

Yale University

Enrollment

20 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Pain, ToleranceOral vs Vaporized THCAbuse Liability

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.

Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria17

  • 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
  • Clinically significant medical disorders (e.g. liver/kidney dysfunction, immunosuppressing conditions, history or presence of epilepsy, seizures, head trauma with loss of consciousness)
  • 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)
  • 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)
  • 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
  • Contraindications for exposure to nociceptive stimuli, such as untreated hypertension
  • 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)
  • Major neurocognitive disorders precluding participation, evidenced by a clinical exam
  • Abnormal EKG, arrythmia, vasospastic disease, chronic heart failure, or presence of a pacemaker
  • Elevation of liver enzymes (ALT, AST) 2x the normal limit or higher
  • Personal or family history of primary psychotic disorders, or mood disorders with psychotic features
  • Current suicidal ideation
  • Allergy or serious adverse reactions to sesame oil, THC, or cannabis
  • Having received any drug as part of a research study within 30 days prior to receiving the study medication in the current study.

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Interventions

DRUGDronabinol 5 MG

Dronabinol 5 mg

DRUGDronabinol 10 MG

Dronabinol 10mg

DRUG2mg Purified THC in an ethanolic solution

2mg Purified THC in an ethanolic solution

DRUG4mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

DRUGPlacebo

Oral placebo and/or vaporized saline

Locations(1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

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NCT05906511