Health TrialsbyHealthPanel

Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis

ConditionEndometriosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21+
SponsorMclean Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject has provided informed consent

Sex assigned female at birth

Subject is 21 or older

Subject is fluent in English

Disqualifiers

Non-fluent English speakers

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

Currently uses cannabis or cannabinoid products regularly

Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabidiol

    Drug

    Custom formulation of a hemp-derived sublingual solution that is high in CBD and includes other cannabinoids and terpenes.

  • Placebo

    Drug

    An active placebo containing supplemental terpenes matched to the high-CBD product.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-CBD Sublingual ProductExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS)

The VAS is a commonly used pain scale where patients draw a line to indicate their pain level on a 100 millimeter long line anchored by two verbal descriptors for symptom extremes (e.g. "no pain" to "worst imaginable pain"). The VAS will be used to describe different types of endometriosis-related pain (dysmenorrhea (pain during menstruation), dyspareunia (pain during or after intercourse), and non-menstrual chronic pelvic pain). Lower scores indicate less pain.

Time frame
12 weeks

Secondary outcomes

1

Endometriosis Health Profile (EHP-30)

The EHP-30 is a well-validated self-report scale with 30 core items and 23 additional questions related to specific modules and areas of life often impacted by endometriosis symptoms. Lower scores indicate fewer symptoms.

Time frame
12 weeks
2

VAS-IBS

The VAS-IBS queries bowel-related concerns. While initially developed for IBS patients, it is commonly used to assess gastrointestinal symptoms in endometriosis patients. Lower scores indicate fewer bowel symptoms.

Time frame
12 weeks
3

Beck Anxiety Inventory (BAI)

The BAI is a 21 item-self-report measure that can be used to screen for anxiety. Each item on the BAI is rated on a scale of 0 to 3, and is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Lower scores indicate fewer symptoms of anxiety.

Time frame
12 weeks
4

Beck Depression Inventory (BDI)

The BDI is a 21 item-self-report measure that can be used to assess the severity of depression. Each item on the BDI relates to a symptom of depression and is rated by the subject using a 0-3 scale. Lower scores indicate fewer depressive symptoms.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Massachusetts Life Sciences Center

Collaborator

Source ClinicalTrials.gov
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