Cannabidiol and Management of Endometriosis Pain

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. 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 daily pain assessments.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Cannabidiol; Epidiolex; Norethindrone; Norethindrone Acetate

Criteria

Inclusion Criteria:

1. Females ages 18-45 years at the time of enrollment

2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis with associated moderate to severe endometriosis related pain ( > 3 on a VAS)

3. Is not expected to undergo gynecological surgery or other surgical procedure for treatment of endometriosis during the study period

4. Agrees to use approved contraception during the entire study if not surgically sterile

5. Patients using oral contraceptives, vaginal ring, injectable progesterone and/or GnRH agonists/antagonist for contraception and/or management of endometriosis, can be included if both they and their primary provider agree to stopping their medication and transitioning to Norethindrone acetate (NETA) as the primary treatment of endometriosis throughout the study period.

6. Patients using Long-acting reversible contraceptives (LARCs) for contraception and/or management of endometriosis can be included if both they and their primary provider agree to initiate Norethindrone (NETA) as the primary treatment of endometriosis throughout the study period

Exclusion Criteria:

1. Women that are pregnant, breastfeeding or trying to conceive

2. Women with chronic daily opioid use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids for > 14 days per month.

3. Women that are currently using Cannabis based products or have used them within 30 days of enrollment

4. Non-English speaking or inability to read and understand English

5. Women with a BMI > 35 kg/m2

6. Women with known liver disease, such as hepatitis, or with screening LFTS (AST/ALT) > 3 times above the upper limits of normal (ULN) in the past year

7. Women with chronic alcohol use (defined as > 3 drinks per day, averaged over one week)

8. Women with chronic use of drugs (defined as > 10 days/month) that cause somnolence/sedation such as benzodiazepines or Central Nervous System (CNS) depressants that are unwilling or unable to discontinue the medications for the washout period and the duration of the study

9. Women who are currently taking Clobazam or Valproate and are unwilling/unable to discontinue the medication for the washout period and the duration of the study

10. Women with suicidal ideation or uncontrolled depression within the past year

11. Known history of or suspected breast cancer on screening physical exam

12. History of or active deep venous thrombosis or pulmonary embolism

13. History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction)

14. Multiple (> 3) risk factors for arterial vascular disease (e.g. uncontrolled hypertension, diabetes mellitus, hypercholesterolemia, obesity and smoking)

15. Current use of a progestin-containing contraceptive implant