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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
Must not have
Patients who cannot provide consent
Patients under age 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days post-surgery
Awards & highlights
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent for medical procedures.
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I am under 18 years old.
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I am having or have had an open surgery.
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I am scheduled for or have had a revision surgery.
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I cannot have surgery due to other health issues.
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I am not currently using certain medications or substances, including St. John's Wort or drugs for mood and anxiety.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption
Secondary study objectives
PROMIS Bank v2.0 - Pain Behavior
PROMIS Bank v2.0 - Physical Function
Pain Visual Analog Scale (VAS)
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,644 Previous Clinical Trials
958,438 Total Patients Enrolled
2 Trials studying Knee Injuries
241 Patients Enrolled for Knee Injuries
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 Injuries Research Study Groups: Dronabinol, Placebo
Knee Injuries Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT05335252 — Phase 3
Dronabinol 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335252 — Phase 3
~0 spots leftby Dec 2024
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