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RecruitingAccepts healthy volunteersEarly Phase 1

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

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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
PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in… (NCT05906511) | Bored Studies