Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
McLean Hospital
RECRUITING
Belmont
Contact Information
Primary
Staci Gruber, PhD
gruber@mclean.harvard.edu
617-855-2762
Backup
Rosie Smith, M.S.
rsmith@mclean.harvard.edu
617-855-2908
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Experimental: High-CBD Sublingual Product
A custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase.
Placebo_comparator: Placebo
Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase.
Related Therapeutic Areas
Sponsors
Collaborators: Massachusetts Life Sciences Center
Leads: Mclean Hospital

This content was sourced from clinicaltrials.gov