CBD for Endometriosis Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how cannabidiol (CBD) can aid in pain relief and enhance the quality of life for individuals with endometriosis. Participants will test various doses of CBD combined with norethindrone acetate, a standard hormonal therapy, to determine the most effective combination. The study spans 12 weeks, with regular check-ins and daily pain tracking. Individuals diagnosed with endometriosis who experience moderate to severe pain may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
Yes, if you are using oral contraceptives, vaginal ring, injectable progesterone, or GnRH agonists/antagonists, you must stop them and switch to Norethindrone acetate (NETA) for the study. If you use long-acting reversible contraceptives (LARCs), you must also switch to NETA. Additionally, you must stop using cannabis products, opioids, benzodiazepines, CNS depressants, Clobazam, and Valproate for a washout period and the study duration.
Will I have to stop taking my current medications?
Participants may need to stop their current medications. If you are using oral contraceptives or certain other treatments for endometriosis, you might need to switch to Norethindrone acetate (NETA) during the study. Additionally, if you are taking medications that cause drowsiness or certain other drugs, you may need to stop them for a washout period (time without taking certain medications) and the duration of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CBD is generally safe for use. Many individuals using CBD for pain relief report positive outcomes. Studies indicate that only a small number of participants discontinue CBD due to side effects. Specifically, about 4.3% of those using low doses and up to 12.9% using high doses of CBD drop out of studies. In comparison, about 3.5% of those taking a placebo stop participating. This suggests that while some may experience side effects, most find them manageable. Overall, CBD is considered safe, with many users experiencing pain relief without major issues.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about using CBD for endometriosis pain because it offers a new approach compared to traditional hormone-based therapies like birth control pills or pain relievers. Unlike these common treatments, CBD utilizes a natural compound derived from the cannabis plant, which may interact with the body's endocannabinoid system to alleviate pain and inflammation differently. This trial explores both low and high doses of CBD combined with norethindrone acetate, providing insights into how varying levels of CBD might impact pain management. By potentially offering a more targeted and natural alternative, CBD could become a promising option for those seeking relief from endometriosis pain.
What evidence suggests that this trial's treatments could be effective for endometriosis pain?
Studies have shown that cannabidiol (CBD) may help relieve pain linked to endometriosis. Surveys from several countries suggest that many people with this condition find cannabis-based products helpful for managing pain. Participants in similar studies reported not only less pain but also better sleep and reduced anxiety and depression. Some research shows that cannabinoids, the active ingredients in cannabis, can provide modest relief from long-term pain. This trial will evaluate the effectiveness of CBD in managing endometriosis pain by administering either a low dose or high dose of CBD combined with Norethindrone acetate, or a placebo combined with Norethindrone acetate. Additionally, people with endometriosis often use cannabis products when traditional pain treatments don't work well enough.12346
Are You a Good Fit for This Trial?
This trial is for women aged 18-45 with a surgical diagnosis of endometriosis and moderate to severe pain. Participants must not be planning surgery, agree to use contraception, and can switch to Norethindrone acetate for the study duration. Exclusions include high BMI, liver disease, certain medication use, substance abuse issues, chronic opioid use for other pains, current cannabis product use or recent history thereof.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo, low dose CBD, or high dose CBD for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Pharmacokinetic Study (optional)
Participants may opt into pharmacokinetic testing with sublingual CBD
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol (CBD) Extract
- Norethindrone Acetate
- Placebo
Cannabidiol (CBD) Extract is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Symptomatic relief of spasticity in adult patients with multiple sclerosis
- Adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis
- Adjunctive analgesic treatment for moderate to severe pain in adult patients with advanced cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor