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CompletedNCT04672252Updated Mar 7, 2023Results posted

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

A Phase 2/3 interventional study of CBD Oral Disintegrating Tablet (ODT) and Placebo ODT in Pain, Postoperative, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by NYU Langone Health · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Cohort 1 - CBD

    Drug: CBD Oral Disintegrating Tablet (ODT)

  • Placebo comparator
    Cohort 2 - Placebo

    Other: Placebo ODT

Interventions

  • DrugCBD Oral Disintegrating Tablet (ODT)

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

  • OtherPlacebo 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Hour 24 Post-Surgery

  2. 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).

    Time frame: Day 2 Post-Surgery

  3. 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).

    Time frame: Day 7 Post-Surgery

  4. 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).

    Time frame: Day 14 Post-Surgery

  5. 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).

    Time frame: Day 2 Post-Surgery

  6. 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).

    Time frame: Day 7 Post-Surgery

  7. 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).

    Time frame: Day 14 Post-Surgery

Secondary outcomes

  1. Total Opioid Consumption

    Consumption based on patient-self-report

    Time frame: Day 1 Post-Surgery

  2. Total Opioid Consumption

    Consumption based on patient-self-report.

    Time frame: Day 2 Post-Surgery

  3. Total Opioid Consumption

    Consumption based on patient-self-report.

    Time frame: Day 7 Post-Surgery

  4. Total Opioid Consumption

    Consumption based on patient-self-report.

    Time frame: Day 14 Post-Surgery

  5. Number of Completed Doses Out of 3 Maximum Doses/Day

    Based on patient-self-report.

    Time frame: Day 1 Post-Surgery

  6. Number of Completed Doses Out of 3 Maximum Doses/Day

    Based on patient-self-report.

    Time frame: Day 7 Post-Surgery

  7. Number of Completed Doses Out of 3 Maximum Doses/Day

    Based on patient-self-report.

    Time frame: Day 14 Post-Surgery

  8. Patient Satisfaction Score

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

    Time frame: Hour 24 Post-Surgery

  9. Patient Satisfaction Score

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

    Time frame: Day 2 Post-Surgery

  10. Patient Satisfaction Score

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

    Time frame: Day 7 Post-Surgery

  11. Patient Satisfaction Score

    Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

    Time frame: Day 14 Post-Surgery

07

Results

Posted Mar 7, 2023

Participant flow

Participant flow — Overall Study
MilestoneCohort 1 - CBDCohort 2 - Placebo
Started5347
Completed5247
Not completed10
Withdrew: Protocol violation10

Outcome measures

PrimaryPain 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).

Time frame:
Hour 24 Post-Surgery
Reported as:
Mean · score on a scale
Pain Visual Analog Scale (VAS) Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Pain Visual Analog Scale (VAS) Score4.4 ± 3.15.7 ± 3.2
PrimaryPain 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).

Time frame:
Day 2 Post-Surgery
Reported as:
Mean · score on a scale
Pain Visual Analog Scale (VAS) Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Pain Visual Analog Scale (VAS) Score4.7 ± 2.85.3 ± 2.6
PrimaryPain 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).

Time frame:
Day 7 Post-Surgery
Reported as:
Mean · score on a scale
Pain Visual Analog Scale (VAS) Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Pain Visual Analog Scale (VAS) Score2.5 ± 1.93.2 ± 2.7
PrimaryPain 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).

Time frame:
Day 14 Post-Surgery
Reported as:
Mean · score on a scale
Pain Visual Analog Scale (VAS) Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Pain Visual Analog Scale (VAS) Score1.6 ± 1.42.3 ± 2.4
PrimaryNausea 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).

Time frame:
Day 2 Post-Surgery
Reported as:
Mean · score on a scale
Nausea Score on VAS Scale
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Nausea Score on VAS Scale2.1 ± 2.62.5 ± 3.1
PrimaryNausea 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).

Time frame:
Day 7 Post-Surgery
Reported as:
Mean · score on a scale
Nausea Score on VAS Scale
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Nausea Score on VAS Scale0.2 ± 1.10.6 ± 2.1
PrimaryNausea 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).

Time frame:
Day 14 Post-Surgery
Reported as:
Mean · score on a scale
Nausea Score on VAS Scale
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Nausea Score on VAS Scale0.1 ± 0.40.5 ± 1.7
SecondaryTotal Opioid Consumption

Consumption based on patient-self-report

Time frame:
Day 1 Post-Surgery
Reported as:
Mean · morphine milligram equivalent (MME)
Total Opioid Consumption
morphine milligram equivalent (MME)Cohort 1 - CBDCohort 2 - Placebo
Total Opioid Consumption15.2 ± 1219.7 ± 13.6
SecondaryTotal Opioid Consumption

Consumption based on patient-self-report.

Time frame:
Day 2 Post-Surgery
Reported as:
Mean · morphine milligram equivalent (MME)
Total Opioid Consumption
morphine milligram equivalent (MME)Cohort 1 - CBDCohort 2 - Placebo
Total Opioid Consumption10.3 ± 18.716.7 ± 36.6
SecondaryTotal Opioid Consumption

Consumption based on patient-self-report.

Time frame:
Day 7 Post-Surgery
Reported as:
Mean · morphine milligram equivalent (MME)
Total Opioid Consumption
morphine milligram equivalent (MME)Cohort 1 - CBDCohort 2 - Placebo
Total Opioid Consumption59.3 ± 53.267.3 ± 55.2
SecondaryTotal Opioid Consumption

Consumption based on patient-self-report.

Time frame:
Day 14 Post-Surgery
Reported as:
Mean · morphine milligram equivalent (MME)
Total Opioid Consumption
morphine milligram equivalent (MME)Cohort 1 - CBDCohort 2 - Placebo
Total Opioid Consumption8 ± 19.310.3 ± 22.7
SecondaryNumber of Completed Doses Out of 3 Maximum Doses/Day

Based on patient-self-report.

Time frame:
Day 1 Post-Surgery
Reported as:
Mean · Doses
Number of Completed Doses Out of 3 Maximum Doses/Day
DosesCohort 1 - CBDCohort 2 - Placebo
Number of Completed Doses Out of 3 Maximum Doses/Day2.9 ± 0.273 ± 0
SecondaryNumber of Completed Doses Out of 3 Maximum Doses/Day

Based on patient-self-report.

Time frame:
Day 7 Post-Surgery
Reported as:
Mean · Doses
Number of Completed Doses Out of 3 Maximum Doses/Day
DosesCohort 1 - CBDCohort 2 - Placebo
Number of Completed Doses Out of 3 Maximum Doses/Day3 ± 02.7 ± 0.95
SecondaryNumber of Completed Doses Out of 3 Maximum Doses/Day

Based on patient-self-report.

Time frame:
Day 14 Post-Surgery
Reported as:
Mean · Doses
Number of Completed Doses Out of 3 Maximum Doses/Day
DosesCohort 1 - CBDCohort 2 - Placebo
Number of Completed Doses Out of 3 Maximum Doses/Day2.8 ± 0.42.7 ± 1
SecondaryPatient Satisfaction Score

Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Time frame:
Hour 24 Post-Surgery
Reported as:
Mean · score on a scale
Patient Satisfaction Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Patient Satisfaction Score7 ± 35.6 ± 3.7
SecondaryPatient Satisfaction Score

Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Time frame:
Day 2 Post-Surgery
Reported as:
Mean · score on a scale
Patient Satisfaction Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Patient Satisfaction Score7.3 ± 2.56 ± 3.3
SecondaryPatient Satisfaction Score

Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Time frame:
Day 7 Post-Surgery
Reported as:
Mean · score on a scale
Patient Satisfaction Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Patient Satisfaction Score8 ± 2.67.9 ± 2.7
SecondaryPatient Satisfaction Score

Patients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).

Time frame:
Day 14 Post-Surgery
Reported as:
Mean · score on a scale
Patient Satisfaction Score
score on a scaleCohort 1 - CBDCohort 2 - Placebo
Patient Satisfaction Score8.7 ± 2.38.5 ± 2.4

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 - CBD0/52 (0%)0/52 (0%)4/52 (7.7%)
Cohort 2 - Placebo0/47 (0%)0/47 (0%)4/47 (8.5%)
Most frequent other events
Most frequent other events
EventCohort 1 - CBDCohort 2 - Placebo
Elevated alanine transaminaseHepatobiliary disorders4/524/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 1 - CBDCohort 2 - PlaceboTotal
Mean58.2 ± 8.857.1 ± 10.157.65 ± 9.45
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 - CBDCohort 2 - PlaceboTotal
Female211738
Male313061
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1 - CBDCohort 2 - PlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino000
Unknown or Not Reported524799
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1 - CBDCohort 2 - PlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported524799
Region of Enrollment
Region of Enrollment(participants)Cohort 1 - CBDCohort 2 - PlaceboTotal
United States524799
08

Study locations

1 site
  • NYU Langone Health
    New York, New York 10016, United States
09

References and documents

Publications

  • 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. PubMed 35905305 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 5, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04672252
Lead sponsor
NYU Langone Health
Collaborators
Orcosa Inc.
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Dec 1, 2020
Primary completion
Dec 16, 2021
Completion
Dec 16, 2022
Results posted
Mar 7, 2023
Last update
Mar 7, 2023

Study contacts

Michael Alaia, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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