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The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)

WithdrawnPhase 1NCT04349930
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function.

Study details

Official title
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Interventions
  • Drug: Cannabidiol vaginal suppository
  • Drug: Placebo vaginal suppository
Sponsor
University of New Mexico
Start date
2021-01
Primary completion
2022-07
Sex
Female
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04349930