Status:
WITHDRAWN
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Lead Sponsor:
University of New Mexico
Conditions:
Interstitial Cystitis
Bladder Pain Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This study seeks to exploit bladder cannabidiol receptors as a therapeutic drug target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabi...
Detailed Description
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic inflammatory disease with an insidious course and is detrimental weight to women's quality of life, sexual function, and general healt...
Eligibility Criteria
Inclusion
- Female Subjects ≥ 18 years of age
- Interstitial cystitis (IC) diagnosis
- English speaking/reading
- Prior treatment with one known treatment for IC: behavioral modifications, pelvic floor physical therapy, medications (amitriptyline, cimetidine, pentosane polysulfate sodium, or hydroxyzine), bladder instillations, bladder hydrodistention, cystoscopic fulguration or injection of Hunner's lesions, intradetrusor injection of botulinum toxin, or sacral neuromodulation
- Females of childbearing potential must use contraception throughout the study period (hormonal contraception, diaphragm, cervical cap, vaginal sponge, condoms, vasectomy, long acting reversible contraception)
- Females of non-child bearing potential must be post-menopausal defined as: \> 51yo with no menses within the past 12mo or history of hysterectomy or history of bilateral oophorectomy or bilateral tubal ligation
Exclusion
- THC or cannabidiol use within 1 month prior to enrollment per patient report
- Positive urine marijuana drug test on day of study enrollment
- Plan to use concomitant THC or cannabidiol of any form during the 6 week study period
- Inability to speak/understand English
- Pregnant or planning on becoming pregnant
- Unable to be contacted for follow up by telephone
- Cocoa butter allergy
- AST or ALT greater than 3 times the upper limit of normal at time of enrollment
- Females of childbearing potential with a positive urine pregnancy test at screening/prior to administration of Day 1 of treatment
- Subjects taking prescription or non-prescription medication which are substrates of CYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP2C19, CYP1A2 and CYP2B6 within 14 days of the study procedure
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04349930
Start Date
January 1 2021
End Date
September 1 2022
Last Update
January 15 2021
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131