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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)

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol vaginal suppository
Placebo vaginal suppository
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Bladder pain syndrome, IC, BPS, CBD, Cannabidiol, Hemp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

CBD vaginal suppository

Placebo vaginal suppository

Outcomes

Primary Outcome Measures

Urinary Pain Severity Scores
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
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
Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test

Full Information

First Posted
April 13, 2020
Last Updated
January 12, 2021
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04349930
Brief Title
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Acronym
CHRONIC
Official Title
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Need to obtain IND approval.
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
Interstitial cystitis, Bladder pain syndrome, IC, BPS, CBD, Cannabidiol, Hemp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Double-masked, placebo-controlled randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-masked (patient and provider)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
CBD vaginal suppository
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo vaginal suppository
Intervention Type
Drug
Intervention Name(s)
Cannabidiol vaginal suppository
Intervention Description
Cannabidiol vaginal suppository
Intervention Type
Drug
Intervention Name(s)
Placebo vaginal suppository
Intervention Description
Placebo vaginal suppository
Primary Outcome Measure Information:
Title
Urinary Pain Severity Scores
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Urinary Symptom Severity Scores
Description
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.
Time Frame
6 weeks
Title
Marijuana Urine Drug Test
Description
Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gena Dunivan, M.D.
Organizational Affiliation
University of New Mexico Department of Urogynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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