A Phase 2/3 interventional study of Cannabidiol and Placebo in Urinary Stone, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Supportive care
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.
159 studies on the registry are indexed under Urinary Calculi; 29 are open to participants now.
This study's enrollment of 90 is below the median of 112 across 108 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Cannabidiol
Drug: Placebo
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
The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
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.
Time frame: postoperative Day 3
Postoperative Rescue Narcotic Use
The number of subjects who required rescue narcotic use post ureteroscopy
Time frame: postoperative Day 3
Total Urinary Symptoms Score
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.
Time frame: postoperative day 1 and postoperative day 3
The Number of Subjects With Adverse Events
The count of subjects who experienced adverse events
Time frame: 3 days post-ureteroscopy
| Milestone | CBD Oil Group | Control Group |
|---|---|---|
| Started | 45 | 45 |
| Completed | 45 | 45 |
| Not completed | 0 | 0 |
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.
| score on a scale | CBD Oil Group | Control Group |
|---|---|---|
| Maximum Pain Intensity Score | 3.6 ± 2.4 | 3.2 ± 2.8 |
The number of subjects who required rescue narcotic use post ureteroscopy
| Participants | CBD Oil Group | Control Group |
|---|---|---|
| Postoperative Rescue Narcotic Use | 8 | 9 |
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.
| score on a scale | CBD Oil Group | Control Group |
|---|---|---|
| Postoperative day 1 | 31 ± 5.5 | 33 ± 6.6 |
| Postoperative day 3 | 27 ± 5.8 | 27 ± 6.9 |
The count of subjects who experienced adverse events
| Participants | CBD Oil Group | Control Group |
|---|---|---|
| Nausea | 3 | 2 |
| Constipation | 10 | 9 |
| Diarrhea | 3 | 1 |
| Poor appetite | 8 | 4 |
| Poor sleep | 11 | 5 |
| Drowiness | 11 | 8 |
| Dizziness | 7 | 5 |
| Tiredness | 17 | 13 |
| Itching | 2 | 2 |
| Headache | 4 | 4 |
Collected over Adverse events were collected from each subject from baseline to end of study for a total of 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBD Oil Group | 0/45 (0%) | 0/45 (0%) | 24/45 (53.3%) |
| Control Group | 0/45 (0%) | 0/45 (0%) | 21/45 (46.7%) |
| Event | CBD Oil Group | Control Group |
|---|---|---|
| TirednessGeneral disorders | 17/45 | 13/45 |
| Poor sleepPsychiatric disorders | 11/45 | 5/45 |
| DrowsinessNervous system disorders | 11/45 | 8/45 |
| ConstipationGastrointestinal disorders | 10/45 | 9/45 |
| Poor AppetiteMetabolism and nutrition disorders | 8/45 | 4/45 |
| DizzinessNervous system disorders | 7/45 | 5/45 |
| HeadacheNervous system disorders | 4/45 | 4/45 |
| NauseaGeneral disorders | 3/45 | 2/45 |
| DiarrheaGastrointestinal disorders | 3/45 | 1/45 |
| ItchingSkin and subcutaneous tissue disorders | 2/45 | 2/45 |
| Age, Continuous(years) | CBD Oil Group | Control Group | Total |
|---|---|---|---|
| Mean | 61.0 ± 12.3 | 58.0 ± 14.4 | 59.7 ± 13.37 |
| Sex: Female, Male(Participants) | CBD Oil Group | Control Group | Total |
|---|---|---|---|
| Female | 28 | 27 | 55 |
| Male | 17 | 18 | 35 |
| Race and Ethnicity Not Collected(Participants) | CBD Oil Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | CBD Oil Group | Control Group | Total |
|---|---|---|---|
| United States | 45 | 45 | 90 |
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