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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBD Oil Group

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

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

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Epidiolex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No