Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
NCT Number: NCT06477406
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Endometriosis
Interventions: DRUG: Cannabidiol|DRUG: Placebo
Sponsor: Mclean Hospital
Collaborators: Massachusetts Life Sciences Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-06

Summary:
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.

Primary Outcome Measures: Visual Analog Scale (VAS), 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., 12 weeks
Secondary Outcome Measures: Endometriosis Health Profile (EHP-30), The EHP-30 is a well-validated self-report scale with 30 core items and 23 additional questions related to specific modules and areas of life often impacted by endometriosis symptoms. Lower scores indicate fewer symptoms., 12 weeks|VAS-IBS, The VAS-IBS queries bowel-related concerns. While initially developed for IBS patients, it is commonly used to assess gastrointestinal symptoms in endometriosis patients. Lower scores indicate fewer bowel symptoms., 12 weeks|Beck Anxiety Inventory (BAI), The BAI is a 21 item-self-report measure that can be used to screen for anxiety. Each item on the BAI is rated on a scale of 0 to 3, and is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Lower scores indicate fewer symptoms of anxiety., 12 weeks|Beck Depression Inventory (BDI), The BDI is a 21 item-self-report measure that can be used to assess the severity of depression. Each item on the BDI relates to a symptom of depression and is rated by the subject using a 0-3 scale. Lower scores indicate fewer depressive symptoms., 12 weeks|Conventional Medication Use, Changes in conventional medication use will be assessed over the course of treatment with study product., 12 weeks|Inflammatory Biomarkers, Saliva samples will be used to quantify levels of common inflammatory markers (e.g. IL-1β, IL-6, IL-8, TNF-α). Lower levels of inflammatory markers indicate less systemic inflammation., 12 weeks|Circulating Endocannabinoid Concentrations, Plasma will be analyzed for circulating levels of endocannabinoids and related compounds (e.g., AEA, 2-AG, 2-OG, PEA, OEA)., 12 weeks