Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Description

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

Endometriosis

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Study Overview

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Study Details

Study 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.

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Condition
Endometriosis
Intervention / Treatment

-

Contacts and Locations

Belmont

McLean Hospital, Belmont, Massachusetts, United States, 02478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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 breastfeeding
  • 5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
  • 6. Neuropathic pain or cancer-related pain
  • 7. Disclosure of a genetic polymorphism affecting CYP2C9 function

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mclean Hospital,

Staci Gruber, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

2026-06