CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
CBD Oral Disintegrating Tablet (ODT) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04672252
NCT04672252Phase 3Completed

The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy; A Double-Blind, Randomized Control Study

NYU Langone Health·interventional·Posted Dec 17, 2020·Updated Mar 7, 2023

In Brief

A Phase 3 clinical trial evaluating CBD Oral Disintegrating Tablet (ODT) and Placebo ODT for Pain, Postoperative. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsOrcosa Inc.

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartDec 1, 2020
Primary CompletionDec 16, 2021
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.5 years ago

Interventions

CBD Oral Disintegrating Tablet (ODT)drug

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

Placebo ODTother

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.