Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.
详细描述
Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.
This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent
- •Sex assigned female at birth
- •Subject is 21 or older
- •Subject is fluent in English
- •Subject endorses at least moderate levels of pain at the baseline visit
- •Subject endorses having endometriosis
排除标准
- •Non-fluent English speakers
- •Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
- •Currently uses cannabis or cannabinoid products regularly
- •Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- •Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
- •Neuropathic pain or cancer-related pain
- •Disclosure of a genetic polymorphism affecting CYP2C9 function
研究组 & 干预措施
Placebo
Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase.
干预措施: Placebo (Drug)
High-CBD Sublingual Product
A custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase.
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 12 weeks
The VAS is a commonly used pain scale where patients draw a line to indicate their pain level on a 100 millimeter long line anchored by two verbal descriptors for symptom extremes (e.g. "no pain" to "worst imaginable pain"). The VAS will be used to describe different types of endometriosis-related pain (dysmenorrhea (pain during menstruation), dyspareunia (pain during or after intercourse), and non-menstrual chronic pelvic pain). Lower scores indicate less pain.
次要结局
- Endometriosis Health Profile (EHP-30)(12 weeks)
- VAS-IBS(12 weeks)
- Beck Anxiety Inventory (BAI)(12 weeks)
- Beck Depression Inventory (BDI)(12 weeks)
- Conventional Medication Use(12 weeks)
- Inflammatory Biomarkers(12 weeks)
- Circulating Endocannabinoid Concentrations(12 weeks)
研究者
Staci Gruber, Ph.D.
Director, Marijuana Investigations for Neuroscientific Discovery (MIND); Director, Cognitive and Clinical Neuroimaging Core (CCNC)
Mclean Hospital