Back to resultsA Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Primary Purpose
Urinary Stone
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Stone
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CBD Oil Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Postoperative Rescue Narcotic Use
The number of subjects who required rescue narcotic use post ureteroscopy
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.
The Number of Subjects With Adverse Events
The count of subjects who experienced adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04387617
Brief Title
A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
Official Title
Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBD Oil Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
Epidiolex
Intervention Description
The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
Primary Outcome Measure Information:
Title
Maximum Pain Intensity Score
Description
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.
Time Frame
postoperative Day 3
Secondary Outcome Measure Information:
Title
Postoperative Rescue Narcotic Use
Description
The number of subjects who required rescue narcotic use post ureteroscopy
Time Frame
postoperative Day 3
Title
Total Urinary Symptoms Score
Description
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.
Time Frame
postoperative day 1 and postoperative day 3
Title
The Number of Subjects With Adverse Events
Description
The count of subjects who experienced adverse events
Time Frame
3 days post-ureteroscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Stern, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
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