Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabidiol, Placebo.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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 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.
Interventions
- Drug Cannabidiol
Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes. - Drug Placebo
An active placebo containing supplemental terpenes matched to the high-CBD product.
Primary outcome measures
- Visual Analog Scale (VAS) [Time frame: 12 weeks]
Secondary outcome measures (7)
- Endometriosis Health Profile (EHP-30) [Time frame: 12 weeks]
- VAS-IBS [Time frame: 12 weeks]
- Beck Anxiety Inventory (BAI) [Time frame: 12 weeks]
- Beck Depression Inventory (BDI) [Time frame: 12 weeks]
- Conventional Medication Use [Time frame: 12 weeks]
- Inflammatory Biomarkers [Time frame: 12 weeks]
- Circulating Endocannabinoid Concentrations [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT06477406 · 2024P001549