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The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy

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ClinicalTrials.gov Identifier: NCT04672252
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Score on Pain Visual Analog Scale (VAS) [ Time Frame: 14 days ]
    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable)
  • Nauseau on VAS scale [ Time Frame: 14 days ]
    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • CBD consumption [ Time Frame: Day 1, 7, 14 ]
    patient self report
  • Opioid consumption [ Time Frame: Day 1, 7, 14 ]
    patient self report
  • Patient Satisfaction [ Time Frame: Day 1, 7, 14 ]
    Patients will record their satisfaction with their management, on a 0-10 scale, 24 hours, 2 days and 7 days, and 14 days after surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Official Title  ICMJE The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
Brief Summary This study is designed to evaluate the effects of administering CBD to control post-operative pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Other: CBD Oral Disintegrating Tablet (ODT)
    Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
  • Other: Placebo ODT

    Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.

    The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.

Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Other: CBD Oral Disintegrating Tablet (ODT)
  • Placebo Comparator: Cohort 2
    Intervention: Other: Placebo ODT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair)
  • Patients ages 18-75, inclusive
  • Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
  • Male patients must be using an effective form of contraception

Exclusion Criteria

  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age
  • Older than 75 years of age
  • Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
  • History of cannabis abuse or dependence
  • History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
  • History of stroke or acute coronary syndromes within 3 months before surgery
  • Abnormal coagulation profile
  • Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
  • Patients with a history of hypersensitivity to Percocet
  • Patients that have been on pre-operative opioid management for any reason
  • Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
  • Patients diagnosed with major depression, psychosis, or substance abuse disorder
  • Patients with current or a history of suicidal ideation
  • Breastfeeding females
  • Patients with clinically significant illness, including cardiovascular disorders
  • Clinically significant lab abnormalities
  • Abnormal LFTs
  • Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
  • Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
  • Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly
  • Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly
  • Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Alaia, MD (646)-501-7223 michael.alaia@nyulangone.org
Contact: Eoghan Hurley, MD (646)-467-0851 eoghan.hurley@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672252
Other Study ID Numbers  ICMJE 19-01293
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Alaia, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP