Clincosm LogoSign in Get a demo

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

Sponsor
NYU Langone Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04672252
Collaborator
Orcosa Inc. (Other)
99
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CBD Oral Disintegrating Tablet (ODT)
  • Other: Placebo ODT
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Other: CBD Oral Disintegrating Tablet (ODT)
Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
Placebo Comparator: Cohort 2

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.

Outcome Measures

Primary Outcome Measures

  1. Score on Pain Visual Analog Scale (VAS) [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)

  2. Nauseau on VAS scale [14 days]

    Any nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable)

Secondary Outcome Measures

  1. CBD consumption [Day 1, 7, 14]

    patient self report

  2. Opioid consumption [Day 1, 7, 14]

    patient self report

  3. Patient Satisfaction [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.

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • Orcosa Inc.

Investigators

  • Principal Investigator: Michael Alaia, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04672252
Other Study ID Numbers:
  • 19-01293
First Posted:
Dec 17, 2020
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Aug 5, 2022