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

Launched by YALE UNIVERSITY · Jun 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different ways of taking delta-9-tetrahydrocannabinol (THC), the main active ingredient in cannabis, affect older adults. Researchers want to understand how THC can help relieve pain and how it might affect older people differently compared to younger users. The trial will compare THC taken as a pill (oral) versus inhaled (vaporized) to see which method is more effective and safe for managing pain in older adults.

To participate in this study, you need to be at least 65 years old and have used THC or cannabis at least once in the last 10 years. However, you cannot be currently using any cannabis products or have certain medical or psychological conditions that could interfere with the study. Participants will be closely monitored during the trial and will receive either THC or a placebo (a non-active treatment) to help ensure the results are accurate. This study is significant because it focuses on older adults, who are increasingly using cannabis for pain relief, and aims to provide important information about its safety and effectiveness in this age group.

Gender

ALL

Eligibility criteria

• 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.