Dronabinol for Endometriosis

Not yet recruiting at 1 trial location

Overseen By Adetola Vaughan, MA Psychology

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Baylor College of Medicine

Must not be taking: Cannabinoids, Opioids, Benzodiazepines, others

Disqualifiers: Obesity, Psychiatric illness, Cardiac disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dronabinol, a synthetic form of THC, to determine its effectiveness in reducing chronic pelvic pain associated with endometriosis. Participants will take either dronabinol or a placebo for 8 weeks to evaluate its safety and potential benefits. Women diagnosed with endometriosis who have experienced pain for at least three months may be suitable for this study. The goal is to assess whether dronabinol is safe enough for consideration in future, more extensive trials. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires participants to stop using cannabis, marijuana, and any other cannabinoids, including over-the-counter CBD products. Participants using oral contraceptives or vaginal rings for endometriosis must agree to stop these medications and switch to dronabinol as the primary treatment during the study. Additionally, participants must not start new pain medications or increase their current doses during the study.

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

Research has shown that dronabinol is generally safe for people. It helps with conditions like weight loss in HIV patients and nausea from cancer treatments. Common side effects include dry mouth, dizziness, and headache, which are usually mild to moderate. Evidence also indicates that dronabinol is safe for long-term use in treating certain types of pain, such as nerve pain. However, dronabinol can harm an unborn baby, so it should not be used during pregnancy. Overall, while some side effects may occur, most patients tolerate dronabinol well. ^{1 2 3 4 5}

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

Unlike the standard of care for endometriosis, which typically involves hormonal therapies and pain medications, dronabinol is derived from cannabis and offers a novel approach by potentially interacting with the body's endocannabinoid system. This system plays a role in regulating pain and inflammation, which are central issues in endometriosis. Researchers are excited about dronabinol because it might provide pain relief without the side effects associated with hormone treatments, such as weight gain or mood swings. Additionally, it could offer an alternative for those who do not respond well to existing medications.

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

Research has shown that dronabinol, a synthetic version of THC, may help reduce chronic pain. In a study with 1,145 patients experiencing difficult-to-treat chronic pain, adding dronabinol significantly lowered average pain levels. Other research suggests that cannabis, which contains THC, can relieve pain and other symptoms related to endometriosis. Reports indicate that cannabis use improved sleep and reduced anxiety for those with pelvic pain. This trial will evaluate the effectiveness of dronabinol in managing chronic pelvic pain associated with endometriosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher Verrico, PhD in Pharmacology

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for up to 75 individuals with chronic pelvic pain due to endometriosis. Participants will be randomly assigned in a 2:1 ratio to receive either the study drug or a placebo, without knowing which one they are getting.

Inclusion Criteria

I am fluent in English.

Stated willingness to comply with all study procedures and availability for the duration of the study

I agree to follow specific lifestyle guidelines during the study.

Exclusion Criteria

Treatment with another investigational drug or other intervention within 3 months of the screening visit

I am allergic to cannabis, CBD, THC, or similar substances.

I currently use cannabis or CBD products and do not want to stop.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dronabinol or placebo capsules, twice per day for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview The DARP study tests if dronabinol (synthetic THC) can reduce endometriosis-associated chronic pelvic pain. Participants will take up to 30 mg/day of this oral medication or a placebo over an eight-week period at Texas Children's Hospital.

How Is the Trial Designed?

Group I: Dronabinol Experimental Treatment 1 Intervention

Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.

Group II: Placebo Placebo Group 1 Intervention

Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Among older adults, those with chronic obstructive pulmonary disease (COPD) were more likely to use synthetic oral cannabinoids (0.6%) compared to those without COPD (0.3%), indicating a higher prevalence of off-label use in this population.

Older adults with COPD not only used synthetic cannabinoids more frequently but also for longer durations and at higher doses, raising potential safety concerns that warrant further research on the respiratory effects of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Synthetic Oral Cannabinoid use Among Older Adults with Chronic Obstructive Pulmonary Disease: A Population-Based Cohort Study. Vozoris, NT., Yao, Z., Li, P., et al.[2020]

The endocannabinoid system (ECS) is identified as a promising target for managing severe pain associated with endometriosis, which is often inadequately addressed by current medical and hormonal therapies.

This review highlights the complex pain mechanisms in endometriosis and suggests that modulating the ECS could provide new strategies for effective pain relief in affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Significance of Endocannabinoids in Endometriosis Pain Management. Bouaziz, J., Bar On, A., Seidman, DS., et al.[2020]

Cannabis use is increasing due to decriminalization and legalization, but its adverse effects, including cardiovascular and pulmonary issues, as well as links to malignancy and neuropsychiatric disorders, are becoming more evident despite limited research.

The rise in cannabis use among minors has led to more cases of overdose and toxicity, highlighting concerns about its safety, particularly regarding impaired driving and motor vehicle accidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Impact of Cannabis on Human Health. Chandy, M., Nishiga, M., Wei, TT., et al.[2023]

In a study of 1,145 patients with refractory chronic pain, adding Δ9-tetrahydrocannabinol (dronabinol) to their treatment significantly reduced average pain intensity from 46.3 to 26.8 mm on a visual analog scale over 12 weeks.

Dronabinol was well tolerated, with 46.8% of patients reporting mild drug-related adverse events, and many patients were able to reduce or stop other pain medications during the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Tolerability of Dronabinol Use in Patients with Chronic Pain: A Retrospective Analysis of 12-Week Open-Label Real-World Data Provided by the German Pain e-Registry. Ueberall, MA., Horlemann, J., Schuermann, N., et al.[2022]

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]

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.

Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]

Citations

1. withpower.com withpower.com/trial/dronabinol-for-endometriosis-dbf50

Dronabinol for Endometriosis · Info for Participants In a study of 1,145 patients with refractory chronic pain, adding Δ9-tetrahydrocannabinol (dronabinol) to their treatment significantly reduced average pain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06834997?cond=%22Endometriosis%22&viewType=Table&rank=10

Dronabinol As an Adjunct for Reducing Pain (DARP)- ... Has chronic endometriosis pain that has persisted at least 3 months and has resulted in pain as determined by the Endometriosis Health Profile Questionnaire ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8547625/

Effects of cannabis ingestion on endometriosis-associated ... Previous research on the use of illicit cannabis in women with endometriosis has shown promise in the treatment of endometriosis pain and co-morbid symptoms ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0165614724002153

Endometriosis: cannabidiol therapy for symptom relief The studies have a range of outcome measures, including recruitment/retention, pelvic pain severity, fatigue, anxiety, depression, and overall health quality.

5. liebertpub.com liebertpub.com/doi/10.1089/imr.2024.0017

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06834997?cond=%22Endometriosis%22&viewType=Table&rank=10

Dronabinol As an Adjunct for Reducing Pain (DARP)- ... Endometriosis is a progressive, chronic inflammatory disorder that affects approximately 10% of women of reproductive age, with up to 70% to 90% of patients ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/018651s029lbl.pdf

MARINOL (dronabinol) capsules, for oral use MARINOL, a synthetic cannabinoid, may cause fetal harm. Avoid use of MARINOL in pregnant women. Although there is little published data on the ...

8. go.drugbank.com go.drugbank.com/drugs/DB00470

Dronabinol: Uses, Interactions, Mechanism of Action Dronabinol is a synthetic delta-9-THC used in the treatment of anorexia and weight loss in HIV patients as well as nausea and vomiting in cancer chemotherapy.

9. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/related_files/cannabis-2022-update-surv-rep-2.pdf

2022 Update—Surveillance Report 2 Dronabinol is a safe long-term treatment option for neuropathic pain patients. Eur. Neurol. 2017;78(5-6):320-9. doi: 10.1159/000481089. PMID ...