Trial Outcomes & Findings for A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones (NCT NCT04387617)

NCT ID: NCT04387617

Last Updated: 2023-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 90 participants
• Primary outcome timeframe: postoperative Day 3
• Results posted on: 2023-01-18

Participant Flow

Participant milestones

Measure	CBD Oil Group Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CBD Oil Group n=45 Participants Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 Participants Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days	Total n=90 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 12.3 • n=45 Participants	58.0 years STANDARD_DEVIATION 14.4 • n=45 Participants	59.7 years STANDARD_DEVIATION 13.37 • n=90 Participants
Sex: Female, Male Female	28 Participants n=45 Participants	27 Participants n=45 Participants	55 Participants n=90 Participants
Sex: Female, Male Male	17 Participants n=45 Participants	18 Participants n=45 Participants	35 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	45 participants n=45 Participants	45 participants n=45 Participants	90 participants n=90 Participants

PRIMARY outcome

Timeframe: postoperative Day 3

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.

Outcome measures

Measure	CBD Oil Group n=45 Participants Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 Participants Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
Maximum Pain Intensity Score	3.6 score on a scale Standard Deviation 2.4	3.2 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: postoperative Day 3

The number of subjects who required rescue narcotic use post ureteroscopy

Outcome measures

Measure	CBD Oil Group n=45 Participants Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 Participants Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
Postoperative Rescue Narcotic Use	8 Participants	9 Participants

SECONDARY outcome

Timeframe: postoperative day 1 and postoperative day 3

Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.

Outcome measures

Measure	CBD Oil Group n=45 Participants Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 Participants Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
Total Urinary Symptoms Score Postoperative day 1	31 score on a scale Standard Deviation 5.5	33 score on a scale Standard Deviation 6.6
Total Urinary Symptoms Score Postoperative day 3	27 score on a scale Standard Deviation 5.8	27 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: 3 days post-ureteroscopy

The count of subjects who experienced adverse events

Outcome measures

Measure	CBD Oil Group n=45 Participants Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 Participants Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
The Number of Subjects With Adverse Events Drowiness	11 Participants	8 Participants
The Number of Subjects With Adverse Events Nausea	3 Participants	2 Participants
The Number of Subjects With Adverse Events Constipation	10 Participants	9 Participants
The Number of Subjects With Adverse Events Diarrhea	3 Participants	1 Participants
The Number of Subjects With Adverse Events Poor appetite	8 Participants	4 Participants
The Number of Subjects With Adverse Events Poor sleep	11 Participants	5 Participants
The Number of Subjects With Adverse Events Dizziness	7 Participants	5 Participants
The Number of Subjects With Adverse Events Tiredness	17 Participants	13 Participants
The Number of Subjects With Adverse Events Itching	2 Participants	2 Participants
The Number of Subjects With Adverse Events Headache	4 Participants	4 Participants

Adverse Events

CBD Oil Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CBD Oil Group n=45 participants at risk Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days.	Control Group n=45 participants at risk Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days
General disorders Nausea	6.7% 3/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	4.4% 2/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Gastrointestinal disorders Constipation	22.2% 10/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	20.0% 9/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Gastrointestinal disorders Diarrhea	6.7% 3/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	2.2% 1/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Metabolism and nutrition disorders Poor Appetite	17.8% 8/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	8.9% 4/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Psychiatric disorders Poor sleep	24.4% 11/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	11.1% 5/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Nervous system disorders Drowsiness	24.4% 11/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	17.8% 8/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Nervous system disorders Dizziness	15.6% 7/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	11.1% 5/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
General disorders Tiredness	37.8% 17/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	28.9% 13/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Skin and subcutaneous tissue disorders Itching	4.4% 2/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	4.4% 2/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days
Nervous system disorders Headache	8.9% 4/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days	8.9% 4/45 • Adverse events were collected from each subject from baseline to end of study for a total of 3 days

Additional Information

Karen L. Stern, M.D.

Mayo Clinic

Phone: 480-342-3868

Email: Stern.Karen@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place