Evaluating a new cannabinoid product for endometriosis treatment
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
This study is testing a new hemp-based product to see if it can help women with endometriosis feel better compared to a placebo over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT06477406 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effects of a custom-formulated, hemp-derived, full-spectrum, high-CBD product compared to a placebo on the symptoms and biomarkers of endometriosis over a 12-week period. The study involves a double-blind crossover design, where participants will undergo 7 visits, including both in-person and remote assessments. The trial will evaluate clinical ratings, medication use, quality of life measures, and collect biological samples to gather comprehensive data on the product's efficacy. This research addresses a significant gap in understanding the potential benefits of cannabinoid products for women's health, particularly for those suffering from endometriosis.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 21 and older who have been diagnosed with endometriosis and experience moderate to severe pain.
Not a fit: Patients who are currently using cannabis or cannabinoid products regularly, or those with certain medical conditions or disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing endometriosis symptoms, potentially improving the quality of life for affected patients.
How similar studies have performed: While there is limited research specifically on cannabinoid products for endometriosis, previous studies have shown potential benefits of cannabinoids for managing chronic pain, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Staci Gruber, PhD — Mclean Hospital
- Study coordinator: Staci Gruber, PhD
- Email: gruber@mclean.harvard.edu
- Phone: 617-855-2762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.