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Dronabinol for Knee Surgery Pain

Phase 3

Recruiting

Led By Vehniah K Tjong, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient who will undergo arthroscopic surgery of the knee including, but not limited to, Meniscectomy, Synovectomy, Chondroplasty, Loose body removal

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 days post-surgery

Awards & highlights

Study Summary

This trial will test whether dronabinol, a medication derived from marijuana, is effective in relieving pain after arthroscopic knee surgery, with the hope of expanding the trial to other types of orthopedic surgery if results are promising.

Who is the study for?

Adults over 18 scheduled for knee arthroscopic surgery can join this trial. They must avoid alcohol, recreational or medical marijuana, CBD products, and certain medications during the study. Pregnant women, those breastfeeding or trying to conceive are excluded, as well as patients with allergies to study drugs, lactose intolerance, severe mental health conditions or substance abuse issues.Check my eligibility

What is being tested?

The trial is testing if Dronabinol helps with pain after knee surgery compared to a placebo. It aims to see if it reduces the need for opioids and has minimal side effects. If successful in reducing postoperative pain without significant negative effects, the scope may broaden to other surgeries.See study design

What are the potential side effects?

Dronabinol might cause dizziness, dry mouth, sleepiness or euphoria. Since it's related to cannabis (marijuana), there could be similar side effects like changes in mood or perception but likely less intense due to controlled dosing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a knee surgery that may include procedures like Meniscectomy or Chondroplasty.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days post-surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Opioid consumption

Secondary outcome measures

PROMIS Bank v2.0 - Pain Behavior

PROMIS Bank v2.0 - Physical Function

Pain Visual Analog Scale (VAS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DronabinolExperimental Treatment1 Intervention

Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Group II: PlaceboPlacebo Group1 Intervention

Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronabinol

2003

Completed Phase 4

~2080

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,221 Total Patients Enrolled

Vehniah K Tjong, MDPrincipal InvestigatorNorthwestern Feinberg School of Medicine

2 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Dronabinol Clinical Trial Eligibility Overview. Trial Name: NCT05335252 — Phase 3

Knee Synovitis Research Study Groups: Dronabinol, Placebo

Knee Synovitis Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT05335252 — Phase 3

Dronabinol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335252 — Phase 3

Frequently Asked Questions

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

Are new participants still being enrolled in this research project?

"Yes, this research is currently recruiting patients. The trial was first announced on June 28th, 2022 and the most recent update was July 1st, 2022."

Answered by AI

What is the FDA's current opinion on Dronabinol?

"Dronabinol has received a safety score of 3 from our analysts at Power. This is because Dronabinol is currently in Phase 3 clinical trials, which suggests that there is both some efficacy data and multiple rounds of safe data supporting its use."

Answered by AI