Scientists investigate THC effects in seniors for pain relief
NCT ID NCT05906511
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study looks at how THC, the main active part of cannabis, affects older adults aged 65 and up. Researchers want to understand how the body processes THC when taken as a pill or inhaled, and how it impacts pain and the risk of misuse. Twenty healthy volunteers with past cannabis use will participate in a controlled setting to gather this important safety and effectiveness data.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Connecticut Healthcare System
RECRUITINGWest Haven, Connecticut, 06516, United States
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