NCT04387617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 18, 2023

Completed
Last Updated

January 18, 2023

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

May 11, 2020

Results QC Date

November 16, 2022

Last Update Submit

December 21, 2022

Conditions

Urinary Stone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative Rescue Narcotic Use

    postoperative Day 3

  • Total Urinary Symptoms Score

    postoperative day 1 and postoperative day 3

  • The Number of Subjects With Adverse Events

    3 days post-ureteroscopy

Study Arms (2)

CBD Oil Group

EXPERIMENTAL
Drug: Cannabidiol

Control Group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CannabidiolDRUG

The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.

Also known as: Epidiolex
CBD Oil Group
PlaceboDRUG

The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Calculi

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Karen L. Stern, M.D.
Organization
Mayo Clinic
Stern.Karen@mayo.edu
480-342-3868

Study Officials

  • Karen Stern, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

February 15, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

January 18, 2023

Results First Posted

January 18, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)