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

Sponsor
Colorado Joint Replacement (Other)
Overall Status
Recruiting
CT.gov ID
NCT04298528
Collaborator
(none)
460
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
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 :
Feb 5, 2020
Anticipated Primary Completion Date :
Feb 5, 2023
Anticipated Study Completion Date :
Feb 5, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morphine Equivalence [30 day's post operative]

      Morphine Equivalence of pain medication used after a total knee replacement

    Secondary Outcome Measures

    1. Nausea [30 day's post operative]

      Patients post operative nausea will be collected as none/mild/moderate/severe

    2. Defense and Veterans Pain Scale [30 day's post operative]

      Patients will keep a pain log after their joint replacement on a scale of 0 - 10

    3. The Pittsburgh Sleep Quality Index [4 weeks and 6 weeks post operative]

      To monitor sleeping habits

    4. Knee Society Score [4 weeks post operative]

      Patient reported outcome

    5. KOOS-12 Knee Survey [6 weeks post operative]

      Patient reported outcome

    6. The Veterans Rand 12-Item Health Survey [6 weeks post operative]

      Patient reported outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado Joint Replacement Denver Colorado United States 80210

    Sponsors and Collaborators

    • Colorado Joint Replacement

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jason Jennings, Orthopedic Surgeon, Colorado Joint Replacement
    ClinicalTrials.gov Identifier:
    NCT04298528
    Other Study ID Numbers:
    • 1554107
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Pain, Postoperative
    Dronabinol

    Study Results

    No Results Posted as of Aug 9, 2021