Actively Recruiting
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Led by Mclean Hospital · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
M
Massachusetts Life Sciences Center
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
S
Staci Gruber, PhD
CONTACT
R
Rosie Smith, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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