Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
ConditionEndometriosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21+
SponsorMclean Hospital
About this trial
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 criteria
Qualifiers
Subject has provided informed consent
Sex assigned female at birth
Subject is 21 or older
Subject is fluent in English
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cannabidiol
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mclean Hospital
Lead sponsor
Massachusetts Life Sciences Center
Collaborator
Source ClinicalTrials.gov