Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Recruiting · NCT06477406 · Interventional (participants receive a specific treatment) · Lead sponsor: Mclean Hospital
View the official record on ClinicalTrials.gov →Interventions studied
CannabidiolPlacebo
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- McLean Hospital - Belmont, Massachusetts, United States