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

NCT04672252 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19-01293
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (7)

• Pain Visual Analog Scale (VAS) Score

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  Hour 24 Post-Surgery

• Pain Visual Analog Scale (VAS) Score

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  Day 2 Post-Surgery

• Pain Visual Analog Scale (VAS) Score

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  Day 7 Post-Surgery

• Pain Visual Analog Scale (VAS) Score

  Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).

  Day 14 Post-Surgery

• Nausea Score on VAS Scale

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

  Day 2 Post-Surgery

• Nausea Score on VAS Scale

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

  Day 7 Post-Surgery

• Nausea Score on VAS Scale

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

  Day 14 Post-Surgery

Secondary Outcomes (11)

• Total Opioid Consumption

  Day 1 Post-Surgery

• Total Opioid Consumption

  Day 2 Post-Surgery

• Total Opioid Consumption

  Day 7 Post-Surgery

• Total Opioid Consumption

  Day 14 Post-Surgery

• Number of Completed Doses Out of 3 Maximum Doses/Day

  Day 1 Post-Surgery

Study Arms (2)

Cohort 1 - CBD

EXPERIMENTAL

Drug: CBD Oral Disintegrating Tablet (ODT)

Cohort 2 - Placebo

PLACEBO COMPARATOR

Other: Placebo ODT

Interventions

CBD Oral Disintegrating Tablet (ODT) DRUG

Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen

Cohort 1 - CBD

Placebo ODT OTHER

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.

Cohort 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Orcosa Inc.: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• Alaia MJ, Li ZI, Chalem I, Hurley ET, Vasavada K, Gonzalez-Lomas G, Rokito AS, Jazrawi LM, Kaplan K. Cannabidiol for Postoperative Pain Control After Arthroscopic Rotator Cuff Repair Demonstrates No Deficits in Patient-Reported Outcomes Versus Placebo: 1-Year Follow-up of a Randomized Controlled Trial. Orthop J Sports Med. 2024 Feb 5;12(2):23259671231222265. doi: 10.1177/23259671231222265. eCollection 2024 Feb.

  PMID: 38322981 DERIVED

• 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.

  PMID: 35905305 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Michael J. Alaia, MD
• Organization: NYU Langone Health

Michael.Alaia@nyulangone.org

(646) 501-7223

Study Officials

• Michael Alaia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2022
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)