The CBD-IC Randomized Controlled Trial: Evaluation of Hemp Cannabidiol SuppositoRies for Pain and Urinary SymptOms in INterstitial Cystitis (CHRONIC)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Urinary Pain Severity Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-masked (patient and provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cannabidiol
CBD vaginal suppository
干预措施: Cannabidiol vaginal suppository (Drug)
Placebo
Placebo vaginal suppository
干预措施: Placebo vaginal suppository (Drug)
结局指标
主要结局
Urinary Pain Severity Scores
时间窗: 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.
次要结局
- Marijuana Urine Drug Test(6 weeks)
- Urinary Symptom Severity Scores(6 weeks)
研究者
Gena Dunivan
M.D, Associate Professor
University of New Mexico