Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Mclean Hospital
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.
Description
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…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject has provided informed consent 2. Sex assigned female at birth 3. Subject is 21 or older 4. Subject is fluent in English 5. Subject endorses at least moderate levels of pain at the baseline visit 6. Subject endorses having endometriosis Exclusion Criteria: 1. Non-fluent English speakers 2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder 3. Currently uses cannabis or cannabinoid products regularly 4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently bre…
Interventions
- DrugCannabidiol
Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.
- DrugPlacebo
An active placebo containing supplemental terpenes matched to the high-CBD product.
Location
- McLean HospitalBelmont, Massachusetts