Clinical trial NCT06477406: Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Official title: Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Life Sciences Center
First posted: 2024-06-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. Endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (WHO, 2023). Existing treatment options are often limited in efficacy and may result in a variety of negative side effects. Previous research has indicated that cannabinoids including cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition.

This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. Participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at McLean Hospital in Belmont, MA, and 3 visits will be conducted remotely. Visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.

Eligibility criteria: Inclusion Criteria:

1. Subject has provided informed consent
2. Sex assigned female at birth
3. Subject is 21 or older
4. Subject is fluent in English
5. Subject endorses at least moderate levels of pain at the baseline visit
6. Subject endorses having endometriosis

Exclusion Criteria:

1. Non-fluent English speakers
2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder
3. Currently uses cannabis or cannabinoid products regularly
4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
6. Neuropathic pain or cancer-related pain
7. Disclosure of a genetic polymorphism affecting CYP2C9 function

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Endometriosis Health Profile (EHP-30)
timeFrame: 12 weeks
measure: VAS-IBS
timeFrame: 12 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: 12 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 12 weeks
measure: Conventional Medication Use
timeFrame: 12 weeks
measure: Inflammatory Biomarkers
timeFrame: 12 weeks
measure: Circulating Endocannabinoid Concentrations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Staci Gruber, PhD
role: PRINCIPAL_INVESTIGATOR
References: