Cannabidiol for Endometriosis

Overseen By Staci Gruber, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mclean Hospital

Must not be taking: Cannabis products

Disqualifiers: Substance use, Psychotic, Eating disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a high-CBD (cannabidiol) product might alleviate endometriosis symptoms. Researchers compare a custom-formulated CBD solution to a placebo to determine its effectiveness in reducing pain and other symptoms over 12 weeks. Women diagnosed with endometriosis who experience moderate pain and do not regularly use cannabis may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you regularly use cannabis or cannabinoid products, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cannabidiol (CBD) is under study for its potential to alleviate endometriosis symptoms. Earlier studies found that people generally tolerated CBD well. Although information on the safety of purified CBD is limited, some clinical trials and real-world studies suggest it is safe and carries a low risk of misuse. While more research is necessary, current findings indicate that CBD might be a safe option for managing endometriosis symptoms. However, always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometriosis?

Unlike standard treatments for endometriosis, which often involve hormonal therapies or pain management medications like NSAIDs, this new approach uses cannabidiol (CBD), a compound derived from hemp. Researchers are excited about CBD because it targets inflammation and pain differently, offering a potentially natural alternative with fewer side effects. This high-CBD sublingual solution is also unique in its delivery method, allowing for rapid absorption into the bloodstream. This could provide quicker and more consistent relief for individuals suffering from endometriosis symptoms.

What evidence suggests that this treatment might be an effective treatment for endometriosis?

This trial will compare a high-CBD sublingual product with a placebo to evaluate its effectiveness in managing endometriosis symptoms. Studies have shown that cannabidiol (CBD) might help manage these symptoms. Users of cannabis-derived extracts, such as CBD, often report significant pain relief and other symptom improvements. CBD appears to reduce inflammation and slow the growth of new blood vessels, which can alleviate pain and enhance quality of life. Survey data also show that most CBD users experience moderate to significant symptom improvements. These findings suggest that CBD could be a promising option for those dealing with endometriosis. ^{1 3 6 7 8}

Who Is on the Research Team?

Staci Gruber, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals assigned female at birth, aged 21 or older, who have been diagnosed with endometriosis and experience moderate levels of pain. Participants must be fluent in English and able to provide informed consent.

Inclusion Criteria

Subject is fluent in English

I have been diagnosed with endometriosis.

I was assigned female at birth.

Exclusion Criteria

Endorsement of current substance use disorder, psychotic disorder, or an eating disorder

I do not have any serious illnesses like heart, liver, kidney diseases, or seizures.

Currently uses cannabis or cannabinoid products regularly

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high-CBD product or placebo over a total of 12 weeks in a double-blind crossover design

12 weeks

4 visits (in-person), 3 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview

The study compares a high-CBD, hemp-derived cannabinoid product against a placebo over 12 weeks to see its effects on symptoms and biomarkers in patients with endometriosis.

How Is the Trial Designed?

Group I: High-CBD Sublingual Product Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Massachusetts Life Sciences Center

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

Cannabidiol (CBD) enhances the effectiveness of conventional breast cancer treatments, paclitaxel (PTX) and doxorubicin (DOX), showing a synergistic effect in breast cancer cell lines (MCF-7 and MDA-MB-231).

The development of CBD-loaded microparticles (CBD-Mps) not only extended the antiproliferative activity for at least 10 days but also improved the efficacy of PTX and DOX, suggesting that CBD can be effectively integrated into breast cancer chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBD loaded microparticles as a potential formulation to improve paclitaxel and doxorubicin-based chemotherapy in breast cancer. Fraguas-Sánchez, AI., Fernández-Carballido, A., Simancas-Herbada, R., et al.[2020]

In a study involving 36 female rats with surgically induced endometriosis, a 5 mg/kg dose of cannabidiol (CBD) significantly reduced the surface area of endometriotic implants and lowered levels of inflammatory markers like IL-6 and TNF-α compared to a saline solution.

CBD also improved total antioxidant status in the serum and peritoneal fluid, showing similar efficacy to the standard treatment leuprolide acetate, suggesting that CBD could be a promising therapeutic option for managing endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a potential novel treatment for endometriosis by its anti-inflammatory, antioxidative and antiangiogenic effects in an experimental rat model. Okten, SB., Cetin, C., Tok, OE., et al.[2023]

Current evidence on the effects of cannabis-based products on endometriosis is limited and primarily derived from laboratory studies, with conflicting results that cannot be reliably applied to human patients.

Due to the lack of robust clinical trials and potential long-term risks associated with cannabis use, such as mood disturbances and cannabis use disorder, national guidelines currently do not recommend cannabis-based products for treating endometriosis in the UK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for the Management of Endometriosis and Chronic Pelvic Pain. Mistry, M., Simpson, P., Morris, E., et al.[2022]

In an in vivo model of endometriosis, daily administration of cannabidiol (CBD) significantly reduced the size and volume of endometriosis lesions, indicating its potential as a therapeutic agent.

CBD demonstrated multiple beneficial effects, including anti-inflammatory, anti-oxidant, and analgesic properties, which contributed to its effectiveness in suppressing endometriosis symptoms and improving lesion morphology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular and Biochemical Mechanism of Cannabidiol in the Management of the Inflammatory and Oxidative Processes Associated with Endometriosis. Genovese, T., Cordaro, M., Siracusa, R., et al.[2022]

A survey of 100 cancer patients revealed that most learned about cannabidiol (CBD) from family or friends, but the majority had never tried it, indicating a gap in patient education.

Patients commonly reported interest in using CBD for managing symptoms like pain, anxiety, and nausea, but many had not tried it due to a lack of knowledge and insufficient recommendations from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol: Knowledge, Beliefs, and Experiences of Patients With Cancer. Butler, TW., Hande, K., Ryan, M., et al.[2021]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a survey of 213 women with endometriosis, 95.5% reported using cannabis primarily for pain relief and improved sleep, with 81% indicating significant improvement in their pain symptoms.

Over 81% of respondents reported that cannabis use led to a reduction in their regular medication usage, with 59% completely stopping medications, particularly analgesics like opioids, suggesting cannabis may serve as an effective alternative for managing endometriosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illicit Cannabis Usage as a Management Strategy in New Zealand Women with Endometriosis: An Online Survey. Armour, M., Sinclair, J., Noller, G., et al.[2021]

In a study involving 20 patients with cannabis use disorder, 30% of participants reduced their daily cannabis consumption by at least 50% after 12 weeks of using inhaled CBD, indicating potential efficacy in treating this condition.

The study suggests that inhalation of CBD allows users to adjust their dosage based on withdrawal symptoms and cravings, highlighting a flexible and user-friendly method of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of Inhaled Cannabidiol in Cannabis Use Disorder: The Pilot Study Cannavap. Cleirec, G., Desmier, E., Lacatus, C., et al.[2022]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

In two case reports, patients experienced significant pain relief from a lumbar compression fracture and thoracic discomfort after using a transdermal CBD cream, suggesting its potential effectiveness for managing pain.

The CBD cream used in the cases demonstrated antisnociceptive and anti-inflammatory properties, indicating that hemp-derived CBD could be a valuable option for treating both acute and chronic pain, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. Eskander, JP., Spall, J., Spall, A., et al.[2020]

Citations

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It seems that cannabidiol could be an effective treatment for endometriosis through inhibition of inflammation and angiogenesis.

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Cannabidiol and Management of Endometriosis Pain

It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to ...

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Evaluating the Current Evidence for the Efficacy of ...

Additional self-reported survey data shows cannabis was efficacious in reducing pelvic pain, improving sleep, and reducing anxiety and ...

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nature.com

nature.com/articles/s44294-024-00032-0

A survey-based, quasi-experimental study assessing ...

Most CBD participants reported at least moderate improvement of symptoms (follow-up 1 = 72.9%, follow-up 2 = 81.1%). Future studies (including ...

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pubmed.ncbi.nlm.nih.gov

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Should cannabis be used in the management of ...

Cross-sectional and retrospective data suggests that people with endometriosis are consuming cannabis to help manage their symptoms. Areas ...

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anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000328572

Medicinal cannabis for endometriosis: The EndoCann Trial

The safety analysis set will be used for all safety analyses. All estimates will be given as 95% confidence intervals, and so with a nominal two-sided type I ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9141153/

Molecular and Biochemical Mechanism of Cannabidiol in the ...

In conclusion, the collected data showed that CBD has an effective and coordinated effects in endometriosis suppression. Keywords: endometriosis, cannabidiol, ...