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Dronabinol After Arthroscopic Surgery

Primary Purpose

Knee Osteoarthritis, Knee Injuries, Meniscus Tear

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Arthroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dronabinol

Placebo

Arm Description

Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Outcomes

Primary Outcome Measures

Opioid consumption
Count of number of hydrocodone/acetaminophen tablet consumed

Secondary Outcome Measures

Pain Visual Analog Scale (VAS)
Scored from 0 (no pain) to 10 (worst possible pain)
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
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).
PROMIS Bank v2.0 - Pain Behavior
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).
PROMIS Bank v2.0 - Physical Function
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.

Full Information

First Posted
April 13, 2022
Last Updated
March 31, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05335252
Brief Title
Dronabinol After Arthroscopic Surgery
Official Title
Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Knee Arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol
Arm Type
Experimental
Arm Description
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Other Intervention Name(s)
Marinol
Intervention Description
5mg 2x daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 caplet 2x daily for 7 days
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Count of number of hydrocodone/acetaminophen tablet consumed
Time Frame
up to 7 days post-surgery
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
Scored from 0 (no pain) to 10 (worst possible pain)
Time Frame
up to 7 days post-surgery
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
Description
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).
Time Frame
up to 21 days post-surgery
Title
PROMIS Bank v2.0 - Pain Behavior
Description
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).
Time Frame
up to 21 days post-surgery
Title
PROMIS Bank v2.0 - Physical Function
Description
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.
Time Frame
up to 21 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa J Shauver, MPH
Phone
312-472-6024
Email
melissa.shauver1@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Abbie P Bennett, MS
Phone
312-922-6024
Email
abbie.bennett@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vehniah K Tjong, MD
Organizational Affiliation
Northwestern Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa J Shauver, MPH
Phone
312-472-6024
Email
melissa.shauver1@nm.org
First Name & Middle Initial & Last Name & Degree
Abbie P Bennett, MS
Phone
312-922-6024
Email
abbie.bennett@nm.org
First Name & Middle Initial & Last Name & Degree
Vehniah K Tjong, MD

12. IPD Sharing Statement

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Dronabinol After Arthroscopic Surgery

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