A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney stones
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-011832
NCT ID: NCT04387617
Sponsor Protocol Number: 19-011832
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Karen Stern, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available