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Cannabinoid

THC for Pain Relief in Older Adults

Q: Are there openings for enrolment in this clinical trial at present?

<p>Reportedly, this medical study is no longer actively seeking recruits. Having been first posted on August 1st 2023 and last updated June 15th of the same year, there are currently no open positions at this time. However, another clinical trial is searching for participants as we speak.</p>

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,531 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,701 Total Patients Enrolled

VA Connecticut Healthcare SystemFED

81 Previous Clinical Trials

6,635 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for enrolment in this clinical trial at present?

"Reportedly, this medical study is no longer actively seeking recruits. Having been first posted on August 1st 2023 and last updated June 15th of the same year, there are currently no open positions at this time. However, another clinical trial is searching for participants as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Joao De Aquino 2023. "PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05906511.

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