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

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ClinicalTrials.gov Identifier: NCT04349930
Recruitment Status : Withdrawn (Need to obtain IND approval.)
First Posted : April 16, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Gena Dunivan, University of New Mexico

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

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Bladder Pain Syndrome Drug: Cannabidiol vaginal suppository Drug: Placebo vaginal suppository Phase 1

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 health. IC/BPS affects nearly 1.2 million women in the United States and although there are currently six lines of treatment, they lack high level evidence and sufficient efficacy. New therapies are in high demand. As the cannabis industry gains popularity in medicine, research has revealed prevalent expression of cannabinoid receptors in bladder detrusor muscle and urothelium suggesting a novel drug target for IC/BPS. This study seeks to exploit this 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. Women with diagnosed IC/BPS will be randomized to treatment with a placebo vaginal suppository or a hemp CBD vaginal suppository. We will monitor changes in their LUTS, pain, and sexual function using validated questionnaires. Our goal is to evaluate whether CBD is an effective, low-risk and less invasive treatment option for IC/BPS. Attainment of this goal would demonstrate a potential novel use for CBD in our Urogynecology patient population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Double-masked, placebo-controlled randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-masked (patient and provider)
Primary Purpose: Treatment
Official Title: The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol
CBD vaginal suppository
Drug: Cannabidiol vaginal suppository
Cannabidiol vaginal suppository

Placebo Comparator: Placebo
Placebo vaginal suppository
Drug: Placebo vaginal suppository
Placebo vaginal suppository




Primary Outcome Measures :
  1. Urinary Pain Severity Scores [ Time Frame: 6 weeks ]
    Compare the efficacy of vaginal CBD suppositories versus vaginal placebo suppositories on pain severity symptoms in IC/BPS patients, as measured by composite pain severity sub-scores of the Genitourinary Pain Index (GUPI) & Interstitial Cystitis Symptom Index (ICSI). The score ranges from 0-27 composite score with higher scores being consistent with more symptomatic disease.


Secondary Outcome Measures :
  1. Urinary Symptom Severity Scores [ Time Frame: 6 weeks ]
    Compare the efficacy of vaginal CBD suppositories versus vaginal placebo suppositories on lower urinary tract symptoms as measured by the composite urinary severity sub-scores of the Genitourinary Pain Index (GUPI) & Interstitial Cystitis Symptom Index (ICSI). The score ranges from 0-25 composite score with higher scores being consistent with more symptomatic disease.

  2. Marijuana Urine Drug Test [ Time Frame: 6 weeks ]
    Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349930


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Gena Dunivan, M.D. University of New Mexico Department of Urogynecology
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Responsible Party: Gena Dunivan, M.D, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT04349930    
Other Study ID Numbers: 00-000
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gena Dunivan, University of New Mexico:
Interstitial cystitis
Bladder pain syndrome
IC
BPS
CBD
Cannabidiol
Hemp
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Epidiolex
Anticonvulsants