Recruiting
Phase 3

Dronabinol

Sponsor:

Colorado Joint Replacement

Code:

NCT04298528

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Dronabinol

Placebo

Study Details

Brief summary:

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

Conditions

Osteoarthritis, Knee

Study ID

NCT04298528

Start date

Feb 5, 2020

Status verified date

Jan, 2023

Completion date

Feb 5, 2025

Anticipated

Primary completion date

Feb 5, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: dronabinol

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.

placebo comparator: placebo

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.

Interventions

Dronabinol

2.5mg 2 times a day for 30 days after total knee replacement

Placebo

2 times a day for 30 days after total knee replacement

Primary outcome measure

  • Morphine Equivalence [ Time Frame: 30 day's post operative ]

Central Contacts and Locations

Central contacts

Rose Johnson

3032602940roseannjohnson@centura.org

Locations

Colorado Joint Replacement

Recruiting

Denver, Colorado, United States, 80210

Contacts

Roseann Johnson

303-260-2940RoseannJohnson@centura.org

Principal Investigator:

Jason Jennings, MD

More Information

Sponsor

Colorado Joint Replacement

Last update posted

Jan 10, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Joint Replacement on 2023-01-10.