PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
Yale University · with VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA) · NCT05906511
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 65+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- October 17, 2023
- Record last updated
- July 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Dronabinol 5 MG; Dronabinol 10 MG; 2mg Purified THC in an ethanolic solution; 4mg Purified THC in an ethanolic solution; Placebo
Conditions: Pain, Tolerance; Oral vs Vaporized THC; Abuse Liability
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
VA Connecticut Healthcare System
West Haven, CT 06516
Site contact: Julia Meyerovich · 203-932-5711 · julia.meyerovich@yale.edu
Study contacts (from the official record)
- Julia Meyerovich, M.S. · 203-623-7493 · julia.meyerovich@yale.edu
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