Clinical trial NCT04672252: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Official title: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Orcosa Inc.
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Visual Analog Scale (VAS) Score
timeFrame: Hour 24 Post-Surgery
measure: Pain Visual Analog Scale (VAS) Score
timeFrame: Day 2 Post-Surgery
measure: Pain Visual Analog Scale (VAS) Score
timeFrame: Day 7 Post-Surgery
measure: Pain Visual Analog Scale (VAS) Score
timeFrame: Day 14 Post-Surgery
measure: Nausea Score on VAS Scale
timeFrame: Day 2 Post-Surgery
measure: Nausea Score on VAS Scale
timeFrame: Day 7 Post-Surgery
measure: Nausea Score on VAS Scale
timeFrame: Day 14 Post-Surgery
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: Day 1 Post-Surgery
measure: Total Opioid Consumption
timeFrame: Day 2 Post-Surgery
measure: Total Opioid Consumption
timeFrame: Day 7 Post-Surgery
measure: Total Opioid Consumption
timeFrame: Day 14 Post-Surgery
measure: Number of Completed Doses Out of 3 Maximum Doses/Day
timeFrame: Day 1 Post-Surgery
measure: Number of Completed Doses Out of 3 Maximum Doses/Day
timeFrame: Day 7 Post-Surgery
measure: Number of Completed Doses Out of 3 Maximum Doses/Day
timeFrame: Day 14 Post-Surgery
measure: Patient Satisfaction Score
timeFrame: Hour 24 Post-Surgery
measure: Patient Satisfaction Score
timeFrame: Day 2 Post-Surgery
measure: Patient Satisfaction Score
timeFrame: Day 7 Post-Surgery
measure: Patient Satisfaction Score
timeFrame: Day 14 Post-Surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alaia MJ, Hurley ET, Vasavada K, Markus DH, Britton B, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Buccally Absorbed Cannabidiol Shows Significantly Superior Pain Control and Improved Satisfaction Immediately After Arthroscopic Rotator Cuff Repair: A Placebo-Controlled, Double-Blinded, Randomized Trial. Am J Sports Med. 2022 Sep;50(11):3056-3063. doi: 10.1177/03635465221109573. Epub 2022 Jul 29.