Recruiting
Phase 2

Cannabinoid Product

Sponsor:

Mclean Hospital

Code:

NCT06477406

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

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

Study ID

NCT06477406

Start date

Feb 27, 2024

Status verified date

Mar, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Cannabidiol

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

Placebo

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

Primary outcome measure

  • Visual Analog Scale (VAS) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Deniz, Grace, Alexa

(617) 855-3338cbdstudy@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

More Information

Sponsor

Mclean Hospital

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-03-18.