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

January 6, 2023 updated by: Jason Jennings, Colorado Joint Replacement

A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Colorado Joint Replacement
        • Principal Investigator:
          • Jason Jennings, MD
        • Sub-Investigator:
          • Douglas Dennis, MD
        • Sub-Investigator:
          • Todd Miner, MD
        • Sub-Investigator:
          • Charlie Yang, MD
        • Contact:
        • Sub-Investigator:
          • Mauricio Mejia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Dronabinol
2.5mg 2 times a day for 30 days after total knee replacement
Other Names:
  • Marinol
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.
Other: Placebo
2 times a day for 30 days after total knee replacement
Other Names:
  • Lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Equivalence
Time Frame: 30 day's post operative
Morphine Equivalence of pain medication used after a total knee replacement
30 day's post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: 30 day's post operative
Patients post operative nausea will be collected as none/mild/moderate/severe
30 day's post operative
Defense and Veterans Pain Scale
Time Frame: 30 day's post operative
Patients will keep a pain log after their joint replacement on a scale of 0 - 10
30 day's post operative
The Pittsburgh Sleep Quality Index
Time Frame: 4 weeks and 6 weeks post operative
To monitor sleeping habits
4 weeks and 6 weeks post operative
Knee Society Score
Time Frame: 4 weeks post operative
Patient reported outcome
4 weeks post operative
KOOS-12 Knee Survey
Time Frame: 6 weeks post operative
Patient reported outcome
6 weeks post operative
The Veterans Rand 12-Item Health Survey
Time Frame: 6 weeks post operative
Patient reported outcome
6 weeks post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Joint Replacement

Investigators

  • Principal Investigator: Jason M Jennings, MD DPT, Colorado Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Anticipated)

February 5, 2024

Study Completion (Anticipated)

February 5, 2025

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1554107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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