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Cannabinoid

CBD Oral Disintegrating Tablet (ODT) for Postoperative Pain

Phase 2 & 3
Waitlist Available
Led By Michael Alaia, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing an arthroscopic shoulder procedure (rotator cuff repair, decompression, labrum repair)
Patients ages 18-75, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 post-surgery
Awards & highlights

Study Summary

This trial will compare CBD to a placebo and opioids for post-operative pain management in shoulder surgery patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nausea Score on VAS Scale
Pain Visual Analog Scale (VAS) Score
Secondary outcome measures
Number of Completed Doses Out of 3 Maximum Doses/Day
Patient Satisfaction Score
Total Opioid Consumption

Side effects data

From 2022 Phase 2 & 3 trial • 100 Patients • NCT04672252
8%
Elevated alanine transaminase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - Placebo
Cohort 1 - CBD

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 1 - CBDExperimental Treatment1 Intervention
Group II: Cohort 2 - PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD Oral Disintegrating Tablet (ODT)
2020
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,358 Previous Clinical Trials
816,713 Total Patients Enrolled
2 Trials studying Postoperative Pain
77 Patients Enrolled for Postoperative Pain
Orcosa Inc.UNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Michael Alaia, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
168 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still space available for participants in this clinical experiment?

"The clinicaltrial.gov website reveals that this medical trial is not presently looking for any more participants. This research was first published on the 1st of December 2020 and its most recent update occured on August 2nd 2022. Though there are no open slots in this study, 483 others trials remain actively recruiting individuals at present."

Answered by AI

Who meets the criteria to join this experiment?

"To be eligible for this clinical trial, potential patients must experience pain postoperatively and fall between the ages of 18-75. At present, 99 individuals are being sought out to participate in the study."

Answered by AI

Does the study's parameters permit octogenarians to participate?

"The minimum and maximum ages for eligibility in this trial are 18 and 75 respectively, as specified by the inclusion criteria."

Answered by AI

Has the FDA given their seal of approval to CBD Oral Disintegrating Tablet (ODT)?

"Since limited information is available on the safety and efficacy of CBD Oral Disintegrating Tablet (ODT), it scored a 1 out of 3."

Answered by AI
Recent research and studies
~24 spots leftby Mar 2025