Interstitial CystitisPhase 1CHRONICNCT04349930
The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
A Phase 1 study testing Cannabidiol vaginal suppository in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Bladder Pain Syndrome
- What is being tested?
- Cannabidiol vaginal suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2021to Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
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.
Read the 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.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Being tested
- Cannabidiol vaginal suppository, Placebo vaginal suppository
- Keywords
- Interstitial cystitis, Bladder pain syndrome, IC, BPS, CBD, Cannabidiol, Hemp
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol vaginal suppositoryDrug
Cannabidiol vaginal suppository
Placebo vaginal suppositoryDrug
Placebo vaginal suppository
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | CBD vaginal suppository Receives: Drug: Cannabidiol vaginal suppository |
| Placebo | Placebo comparator | Placebo vaginal suppository Receives: Drug: Placebo vaginal suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 6 weeks
Marijuana Urine Drug Test
Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study startJan 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Need to obtain IND approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Double-masked, placebo-controlled randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gena Dunivan, University of New Mexico
- Investigators
- Gena Dunivan, M.D., Principal investigator, University of New Mexico Department of Urogynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349930
- Sponsor's protocol ID
- 00-000
- Acronym
- CHRONIC
- Status last verified
- Jan 2021
- First submitted
- 13 Apr 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
- ClinicalTrials.gov ID
- NCT04349930
- Acronym / sponsor ID
- CHRONIC / 00-000
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Keywords
- Interstitial cystitis, Bladder pain syndrome, IC, BPS, CBD, Cannabidiol, Hemp
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Need to obtain IND approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-masked, placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: Cannabidiol vaginal suppositoryCBD vaginal suppository |
| Placebo | Placebo comparator | Drug: Placebo vaginal suppositoryPlacebo vaginal suppository |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol vaginal suppositoryCannabidiol vaginal suppository | Drug | Cannabidiol |
| Placebo vaginal suppositoryPlacebo vaginal suppository | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Urinary Symptom Severity Scores
Time frame: 6 weeks
Marijuana Urine Drug Test
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gena Dunivan, M.D. principal investigator
University of New Mexico Department of Urogynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol vaginal suppository in people with Interstitial Cystitis and Bladder Pain Syndrome, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Pain Severity Scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.