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

Trial Summary

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.

What evidence supports the effectiveness of the drug Cannabidiol (CBD) for treating endometriosis?

Research shows that CBD can help reduce inflammation, pain, and oxidative stress (damage caused by free radicals) in endometriosis, leading to smaller and less painful lesions. Additionally, a survey found that many women with endometriosis reported improved pain relief and reduced use of other pain medications when using cannabis, which includes CBD. ^{1 2 3 4 5}

Is cannabidiol (CBD) safe for human use?

CBD is generally well tolerated in humans, but it can cause some side effects like diarrhea, decreased appetite, and sedation. Serious adverse effects are rare but can include liver issues, especially when CBD interacts with other medications. More research is needed to fully understand its safety, especially outside of specific conditions like epilepsy. ^{1 3 6 7 8}

How does the drug cannabidiol (CBD) work for endometriosis?

Cannabidiol (CBD) is unique for endometriosis treatment because it reduces inflammation, oxidative stress (damage caused by free radicals), and pain, which are common issues in endometriosis. Unlike other treatments, CBD also helps reduce the size and severity of endometriosis lesions and has antifibrotic effects, meaning it can help prevent or reduce scar tissue formation. ^{1 3 9 10 11}

What is the purpose of this trial?

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.

Research Team

Staci Gruber, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

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

I was assigned female at birth.

Subject is fluent in English

I am 21 years old or older.

Exclusion Criteria

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

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

I experience nerve pain or pain related to my cancer.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Molecular and Biochemical Mechanism of Cannabidiol in the Management of the Inflammatory and Oxidative Processes Associated with Endometriosis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

CBD loaded microparticles as a potential formulation to improve paclitaxel and doxorubicin-based chemotherapy in breast cancer. [2020]

3. Netherlands 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol for the Management of Endometriosis and Chronic Pelvic Pain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Illicit Cannabis Usage as a Management Strategy in New Zealand Women with Endometriosis: An Online Survey. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol: Knowledge, Beliefs, and Experiences of Patients With Cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) as a treatment of acute and chronic back pain: A case series and literature review. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Efficiency of Inhaled Cannabidiol in Cannabis Use Disorder: The Pilot Study Cannavap. [2022]