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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours
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 moreTrial 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
1,924 Previous Clinical Trials
3,031,638 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,589 Previous Clinical Trials
3,328,497 Total Patients Enrolled
VA Connecticut Healthcare SystemFED
85 Previous Clinical Trials
8,780 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like asthma or COPD that can cause breathing problems.I do not have major health issues like liver or kidney problems, immune system disorders, or a history of seizures or serious head injuries.I am not taking medications that significantly affect pain or interact with specific enzymes.I am allergic to sesame oil, THC, or cannabis.I have a neurological condition affecting my response to pain or balance.I have heart issues like abnormal heart rhythm or a pacemaker.I am currently experiencing thoughts of harming myself.I am 65 years old or older and in good health.I do not have untreated high blood pressure.I can understand and sign the consent form in English.
Research Study Groups:
This trial has the following groups:- Group 1: Dronabinol 5mg
- Group 2: Dronabinol 10mg
- Group 3: Vaporized THC 4mg
- Group 4: Vaporized THC 2mg
- Group 5: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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