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

Sponsor

University of New Mexico (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04349930

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Double-masked, placebo-controlled randomized trialDouble-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)

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Urinary Pain Severity Scores [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

Urinary Symptom Severity Scores [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.
Marijuana Urine Drug Test [6 weeks]
Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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