Recruiting
Early Phase 1

THC

Sponsor:

Yale University

Code:

NCT05906511

Conditions

Pain, Tolerance

Oral vs Vaporized THC

Abuse Liability

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Dronabinol 5 MG

Dronabinol 10 MG

2mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

Placebo

Study Details

Brief 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.

Conditions

Pain, Tolerance

Oral vs Vaporized THC

Abuse Liability

Study ID

NCT05906511

Start date

Oct 17, 2023

Status verified date

Feb, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Apr 13, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion 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.

Exclusion Criteria:

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Dronabinol 5mg

Dronabinol 5 mg

placebo comparator: Dronabinol 10mg

Dronabinol 10 mg

active comparator: Vaporized THC 2mg

Vaporized THC 2mg

active comparator: Vaporized THC 4mg

Vaporized THC 4 mg

placebo comparator: Placebo

Masked oral placebo or vaporized saline

Interventions

Dronabinol 5 MG

Dronabinol 5 mg

Dronabinol 10 MG

Dronabinol 10mg

2mg Purified THC in an ethanolic solution

2mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

4mg Purified THC in an ethanolic solution

Placebo

Oral placebo and/or vaporized saline

Primary outcome measure

  • Peak concentration (Cmax) [ Time Frame: Up to 8 hours ]
  • Time to attain Cmax concentration (Tmax) [ Time Frame: Up to 8 hours ]
  • Area under the plasma concentration-time curve (AUC0-8h) [ Time Frame: Up to 8 hours ]
  • Nociception [ Time Frame: Up to 8 hours ]
  • Abuse Liability [ Time Frame: Up to 8 hours ]

Central Contacts and Locations

Central contacts

Locations

VA Connecticut Healthcare System

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Principal Investigator:

Joao P. De Aquino, M.D.

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Feb, 2026

Keywords

  • Pharmacokinetics THC
  • Pharmacodynamics THC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.