Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

NCT06477406 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024P001549
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The VAS is a commonly used pain scale where patients draw a line to indicate their pain level on a 100 millimeter long line anchored by two verbal descriptors for symptom extremes (e.g. "no pain" to "worst imaginable pain"). The VAS will be used to describe different types of endometriosis-related pain (dysmenorrhea (pain during menstruation), dyspareunia (pain during or after intercourse), and non-menstrual chronic pelvic pain). Lower scores indicate less pain.

  12 weeks

Secondary Outcomes (7)

• Endometriosis Health Profile (EHP-30)

  12 weeks

• VAS-IBS

  12 weeks

• Beck Anxiety Inventory (BAI)

  12 weeks

• Beck Depression Inventory (BDI)

  12 weeks

• Conventional Medication Use

  12 weeks

Study Arms (2)

High-CBD Sublingual Product

EXPERIMENTAL

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.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase.

Drug: Placebo

Interventions

Cannabidiol DRUG

Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.

High-CBD Sublingual Product

Placebo DRUG

An active placebo containing supplemental terpenes matched to the high-CBD product.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Massachusetts Life Sciences Center: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Staci Gruber, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Staci Gruber, PhD

CONTACT

617-855-2762; gruber@mclean.harvard.edu

Rosie Smith, M.S.

CONTACT

617-855-2908; rsmith@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Marijuana Investigations for Neuroscientific Discovery (MIND); Director, Cognitive and Clinical Neuroimaging Core (CCNC)

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)