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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04387617
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
11.5
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
Actual Study Start Date :
Feb 15, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. Post operative Pain intensity [3 days post-ureteroscopy]

      Patient self-reported pain intensity score using a 100 mm visual analog scale

    Secondary Outcome Measures

    1. Postoperative opioid use [3 days post-ureteroscopy]

      Total dosage of opioids used by patients

    2. Ureteric stent symptoms [1 and 3 days post-ureteroscopy]

      Ureteric stent Symptoms Questionnaire

    3. Side effects and adverse events [3 days post-ureteroscopy]

      post operative adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Phoenix Arizona United States 85054

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Karen Stern, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Karen L. Stern, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04387617
    Other Study ID Numbers:
    • 19-011832
    First Posted:
    May 14, 2020
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Calculi
    Urolithiasis
    Cannabidiol

    Study Results

    No Results Posted as of May 19, 2022