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

NYU Langone Health

Status and phase

Completed

Phase 3

Phase 2

Conditions

Pain, Postoperative

Treatments

Other: Placebo ODT

Drug: CBD Oral Disintegrating Tablet (ODT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04672252

19-01293

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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