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Dronabinol After Arthroscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05335252
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Vehniah Tjong, Northwestern University

Brief Summary:
The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Knee Injuries Meniscus Tear Synovitis of Knee Knee Ligament Injury Chondral Injury of Left Knee Chondral Injury of Right Knee Loose Body Knee Drug: Dronabinol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Dronabinol
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Drug: Dronabinol
5mg 2x daily for 7 days
Other Name: Marinol

Placebo Comparator: Placebo
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Drug: Placebo
1 caplet 2x daily for 7 days




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: up to 7 days post-surgery ]
    Count of number of hydrocodone/acetaminophen tablet consumed


Secondary Outcome Measures :
  1. Pain Visual Analog Scale (VAS) [ Time Frame: up to 7 days post-surgery ]
    Scored from 0 (no pain) to 10 (worst possible pain)

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference [ Time Frame: up to 21 days post-surgery ]
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome).

  3. PROMIS Bank v2.0 - Pain Behavior [ Time Frame: up to 21 days post-surgery ]
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome).

  4. PROMIS Bank v2.0 - Physical Function [ Time Frame: up to 21 days post-surgery ]
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Patient who will undergo arthroscopic surgery of the knee including, but not limited to,

    • Meniscectomy
    • Synovectomy
    • Chondroplasty
    • Loose body removal

Exclusion Criteria:

  • Patients under age 18 years
  • Patients who cannot provide consent
  • Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
  • Patients with an allergy to any of the study drugs
  • Patient who are lactose-intolerant
  • Revision surgery
  • Open surgery
  • Comorbidities preventing surgery
  • Patients with a history of mania, depression, or schizophrenia
  • Patients taking any of the following drugs or supplements

    • Anticholinergic agents
    • Benzodiazepines
    • Central nervous system depressants
    • Droperidol
    • Hydroxyzine
    • Levomepromazine or methotrimeprazine
    • Monoamine oxidase inhibitors
    • Ritonavir
    • Selective serotonin reuptake inhibitors
    • Sympathomimetics
    • St. John's Wort
  • Current diagnosed alcohol or drug abuse
  • Patients who cannot or will not abide by the medication restrictions listed below

Medication restrictions

  • Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period
  • Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05335252


Contacts
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Contact: Melissa J Shauver, MPH 312-472-6024 melissa.shauver1@nm.org
Contact: Abbie P Bennett, MS 312-922-6024 abbie.bennett@nm.org

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Melissa J Shauver, MPH    312-472-6024    melissa.shauver1@nm.org   
Contact: Abbie P Bennett, MS    312-922-6024    abbie.bennett@nm.org   
Principal Investigator: Vehniah K Tjong, MD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Vehniah K Tjong, MD Northwestern Feinberg School of Medicine
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Responsible Party: Vehniah Tjong, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT05335252    
Other Study ID Numbers: STU00213383
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: July 2022

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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.: Yes
Keywords provided by Vehniah Tjong, Northwestern University:
Knee Arthroscopy
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Synovitis
Wounds and Injuries
Knee Injuries
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Leg Injuries
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists