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NCT04298528 | RECRUITING | Osteoarthritis, Knee

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

Colorado Joint Replacement

Information provided by (Responsible Party):

Jason Jennings

Brief Summary:

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

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Dronabinol

Placebo

Phase

PHASE3

Detailed Description:

Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

Study Type : INTERVENTIONAL
Estimated Enrollment : 460 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty
Actual Study Start Date : 2020-02-05
Estimated Primary Completion Date : 2024-02-05
Estimated Study Completion Date : 2025-02-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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
A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

Location Details

NCT04298528

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How to Participate

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Locations

RECRUITING

United States, Colorado

Colorado Joint Replacement

Denver, Colorado, United States, 80210