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

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Mayo Clinic

Status and phase

Completed
Phase 3
Phase 2

Conditions

Urinary Stone

Treatments

Drug: Cannabidiol
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04387617
19-011832

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups, including a placebo group

CBD Oil Group
Experimental group
Treatment:
Drug: Cannabidiol
Control Group
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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