A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

Key facts

Study ID

NCT04298528

Run by

Colorado Joint Replacement

People needed

460

Starts

2020-02-05

Expected to finish

2025-02-05

Last updated by the study team

2023-01-10

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent from
• Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
• Male or Female
• Age 21-75
• Unilateral total knee arthroplasty at Colorado Joint Replacement
• All individuals will be screened for drug use (including cannabis) at their preoperative appointment
• Ability to take oral medication and be willing to adhere to the dronabinol regimen
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

You may not qualify if…

• Narcotic use in the past 6 weeks
• Regular cannabis use in the past 3 months
• Major depression or anxiety disorders
• Documented psychiatric illness (e.g. bipolar, schizophrenia)
• Seizure disorder
• Current or previous history of drug and alcohol abuse
• Known allergic reactions to components of dronabinol
• Tobacco use in the past 90 days
• Treatment with another investigational drug
• Patients that cannot receive spinal anesthesia
• Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)
• Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility

Where it is running

• Colorado Joint Replacement — Denver, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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