A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones

Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi

The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.

Study Overview

• Status: Completed
• Conditions: Urinary Stone
• Intervention / Treatment: Drug: Cannabidiol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution.
• Age 18-75 years of age.
• Patients of either gender.
• Patients of all ethnic backgrounds.
• Capable of giving informed consent.
• Capable and willing to fulfill the requirements of the study.

Exclusion Criteria:

• History of chronic pain.
• Chronic use of opioid or other pain medication (> 12 weeks).
• Known allergy to CBD oil or other cannabinoids.
• Known or suspected pregnancy.
• Inability to give informed consent or unable to meet requirements of the study for any reason.
• Bilateral ureteroscopy.
• Current marijuana, cannabidiol (CBD), or dronabinol use.
• Liver disease/cirrhosis.
• Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Drug: Placebo; The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
Experimental: CBD Oil Group	Drug: Cannabidiol; The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.; Other Names: Epidiolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Pain Intensity Score	Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable.	postoperative Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Rescue Narcotic Use	The number of subjects who required rescue narcotic use post ureteroscopy	postoperative Day 3
Total Urinary Symptoms Score	Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.	postoperative day 1 and postoperative day 3
The Number of Subjects With Adverse Events	The count of subjects who experienced adverse events	3 days post-ureteroscopy

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Karen Stern, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 19-011832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No