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Cannabinoid

Dronabinol for Postoperative Pain (dronabinol Trial)

Phase 3
Recruiting
Led By Jason M Jennings, MD DPT
Research Sponsored by Colorado Joint Replacement
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-75
Male or Female aged 21-75
Must not have
Seizure disorder
Inability to receive spinal anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks and 6 weeks post operative
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This trial found that preoperative medical cannabis use was associated with less postoperative narcotic use.

Who is the study for?
This trial is for adults aged 21-75 undergoing knee replacement at Colorado Joint Replacement who can take oral meds and follow the study plan. They must not have used narcotics in the last 6 weeks, cannabis regularly in the past 3 months, or tobacco recently. No history of major mental disorders, seizures, drug/alcohol abuse, or allergies to dronabinol.
What is being tested?
The trial tests if Dronabinol reduces painkiller needs after knee surgery compared to a placebo. Participants are randomly assigned to receive either Dronabinol or a placebo and their narcotic consumption post-surgery is monitored.
What are the potential side effects?
Dronabinol may cause dizziness, mood changes, weakness, lack of coordination; it might also affect blood pressure and heart rate. The side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 75 years old.
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I am between 21 and 75 years old.
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I am having a knee replacement at Colorado Joint Replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a seizure disorder.
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I cannot have spinal anesthesia.
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I will need to stay in a rehab facility after leaving the hospital.
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I have been diagnosed with major depression or an anxiety disorder.
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I cannot take standard pain medications like Tylenol, gabapentin, or meloxicam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks and 6 weeks post operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks and 6 weeks post operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Morphine Equivalence
Secondary study objectives
Defense and Veterans Pain Scale
KOOS-12 Knee Survey
Knee Society Score
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.
Group II: placeboPlacebo Group1 Intervention
Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved

Find a Location

Who is running the clinical trial?

Colorado Joint ReplacementLead Sponsor
11 Previous Clinical Trials
2,761 Total Patients Enrolled
4 Trials studying Osteoarthritis
619 Patients Enrolled for Osteoarthritis
Jason M Jennings, MD DPTPrincipal InvestigatorColorado Joint Replacement
1 Previous Clinical Trials
496 Total Patients Enrolled
1 Trials studying Osteoarthritis
496 Patients Enrolled for Osteoarthritis

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04298528 — Phase 3
Osteoarthritis Research Study Groups: dronabinol, placebo
Osteoarthritis Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT04298528 — Phase 3
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298528 — Phase 3
~80 spots leftby Nov 2025
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