Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

NCT ID: NCT06477406

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2026-06-30

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.

Detailed Description

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.

This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.

Conditions

Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Cannabidiol

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Life Sciences Center

UNKNOWN

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Staci Gruber, Ph.D.

Director, Marijuana Investigations for Neuroscientific Discovery (MIND); Director, Cognitive and Clinical Neuroimaging Core (CCNC)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Staci Gruber, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Staci Gruber, PhD

Role: CONTACT

gruber@mclean.harvard.edu

617-855-2762

Rosie Smith, M.S.

Role: CONTACT

rsmith@mclean.harvard.edu

617-855-2908

Facility Contacts

Rosie Smith, M.S.

Role: primary

rsmith@mclean.harvard.edu

617-855-2908

Other Identifiers

2024P001549

Identifier Type: -

Identifier Source: org_study_id