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Cannabinoid

THC for Pain Relief in Older Adults

Phase < 1
Recruiting
Led By Joao P. De Aquino, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 hours

Summary

This trial studies how cannabis affects older adults, to see if it helps relieve pain.

Who is the study for?
This trial is for healthy adults aged 65 or older who have used THC or cannabis at least once in the last decade. They must be able to consent and speak English. People with abnormal heart tests, psychiatric disorders, regular use of certain drugs affecting pain perception, serious medical conditions, allergies to sesame oil/THC/cannabis, neurological issues affecting pain response/balance, untreated high blood pressure, or major cognitive disorders cannot join.
What is being tested?
The study is testing how different doses of THC (2mg and 4mg) taken orally or vaporized affect older adults compared to a placebo. It's looking at how quickly THC enters the bloodstream (PK) and its effects on pain tolerance and potential for abuse (PD). Participants will try each form under controlled conditions.
What are the potential side effects?
Possible side effects include dizziness, dry mouth, changes in appetite or mood swings due to THC's psychoactive properties. There may also be short-term memory impairment and coordination issues which are common with cannabinoid use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Abuse Liability
Area under the plasma concentration-time curve (AUC0-8h)
Nociception
+2 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Dronabinol 5mgActive Control1 Intervention
Dronabinol 5 mg
Group II: Vaporized THC 4mgActive Control1 Intervention
Vaporized THC 4 mg
Group III: Vaporized THC 2mgActive Control1 Intervention
Vaporized THC 2mg
Group IV: Dronabinol 10mgPlacebo Group1 Intervention
Dronabinol 10 mg
Group V: PlaceboPlacebo Group1 Intervention
Masked oral placebo or vaporized saline

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,040,375 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,582 Previous Clinical Trials
3,327,020 Total Patients Enrolled
VA Connecticut Healthcare SystemFED
85 Previous Clinical Trials
8,780 Total Patients Enrolled

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05906511 — Phase < 1
Pain Tolerance Research Study Groups: Dronabinol 5mg, Dronabinol 10mg, Vaporized THC 4mg, Vaporized THC 2mg, Placebo
Pain Tolerance Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT05906511 — Phase < 1
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05906511 — Phase < 1
~8 spots leftby Aug 2025
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