RECRUITING

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Quick Facts

Study Start:2024-12
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477406

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has provided informed consent
  2. 2. Sex assigned female at birth
  3. 3. Subject is 21 or older
  4. 4. Subject is fluent in English
  5. 5. Subject endorses at least moderate levels of pain at the baseline visit
  6. 6. Subject endorses having endometriosis
  1. 1. Non-fluent English speakers
  2. 2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
  3. 3. Currently uses cannabis or cannabinoid products regularly
  4. 4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
  5. 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. 6. Neuropathic pain or cancer-related pain
  7. 7. Disclosure of a genetic polymorphism affecting CYP2C9 function

Contacts and Locations

Study Contact

Staci Gruber, PhD
CONTACT
617-855-2762
gruber@mclean.harvard.edu
Rosie Smith, M.S.
CONTACT
617-855-2908
rsmith@mclean.harvard.edu

Principal Investigator

Staci Gruber, PhD
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

  • Staci Gruber, PhD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Endometriosis