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Cannabinoid

Cannabidiol for Endometriosis

Phase 2

Recruiting

Led By Staci Gruber, PhD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is sex assigned female at birth

Subject is 21 or older

Must not have

Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)

Non-fluent English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial aims to investigate the effects of a specific hemp-derived CBD product compared to a placebo on symptoms and biomarkers in women with endometriosis over 12 weeks. The goal is to determine

Who is the study for?

This trial is for individuals assigned female at birth, aged 21 or older, who have been diagnosed with endometriosis and experience moderate levels of pain. Participants must be fluent in English and able to provide informed consent.

What is being tested?

The study compares a high-CBD, hemp-derived cannabinoid product against a placebo over 12 weeks to see its effects on symptoms and biomarkers in patients with endometriosis.

What are the potential side effects?

Potential side effects may include typical CBD-related reactions such as fatigue, changes in appetite, gastrointestinal discomfort, and mood alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was assigned female at birth.

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I am 21 years old or older.

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I experience moderate to severe pain.

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I have been diagnosed with endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses like heart, liver, kidney diseases, or seizures.

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analog Scale (VAS)

Secondary study objectives

Beck Anxiety Inventory (BAI)

Beck Depression Inventory (BDI)

Circulating Endocannabinoid Concentrations

+4 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High-CBD Sublingual ProductExperimental Treatment1 Intervention

A custom-formulated, hemp-derived, full-spectrum high-CBD sublingual solution; 0.75mL of solution will be self-administered three times daily (TID) for the duration of the CBD phase.

Group II: PlaceboPlacebo Group1 Intervention

Placebo solution (0.75mL) will be self-administered TID for the duration of the placebo phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabidiol

2021

Completed Phase 3

~1010

0 / 6Eligibility criteria met