The Effects of CBD Isolate on Menstrual-Related Symptoms

• Sponsor: Canopy Growth Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05679830
• Collaborator: James Madison University (Other)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is:

(1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption.

Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).

Condition or Disease	Intervention/Treatment	Phase
Menstrual Discomfort	Drug: Cannabidiol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms
• Actual Study Start Date: Sep 23, 2020
• Actual Primary Completion Date: Sep 23, 2021
• Actual Study Completion Date: Sep 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 160mg Cannabidiol Isolate 320mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS).	Drug: Cannabidiol; Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.
Experimental: 320mg Cannabidiol Isolate 160mg of CBD Isolate BID for 5 days every month starting the day that participants believed they were having menstrual-related symptoms (MRS).	Drug: Cannabidiol; Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Outcome Measures

Primary Outcome Measures

1. Menstrual-Related Symptoms Questionnaire (MRSQ) [1 menstrual cycle/1 month]

   Change in menstrual-related symptoms from baseline scores as measured by the MRSQ every cycle for three cycles. Scores range from 26-104, with higher scores representing greater severity of symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Participant is at least 18 years old.

2. Participant is willing and able to provide informed consent and participate in the study for 4 months.

3. Participant experiences a regular period (occurring every 21-38 days and lasting between 4-8 days).

4. Participant is diagnosed with Pre-menstrual Dysphoric Disorder or scores at least '30' on the Menstrual-Related Symptom Questionnaire

5. Participant is willing to begin tracking their periods and menstrual symptoms for the duration of the study

6. Participant agrees to abide by all study restrictions and comply with all study procedures.

Exclusion Criteria:

1. Participant has a known history of significant allergic condition, significant hypersensitivity to CBD, or allergic reaction to cannabis, cannabinoid medications, or excipients of the drug product.

2. Participant has been exposed to any investigational drug or device < 30 days prior to screening or plans to take another investigational drug at any time during the study.

3. Participant has self-reported using cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD or Tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.

4. Participant has a current or past primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis that the Investigator(s) determines would interfere in treatment or interfere in evaluation of the study treatment (e.g., current psychotic disorder).

5. Participant is currently prescribed medications with known THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, Mammalian target of rapamycin (mTOR) inhibitors, oral tacrolimus).

6. Participant is trying to get pregnant.

7. Participant is pregnant.

8. Participant has a history of suicide attempt in the last year.

9. Participant endorses current suicidal plan and intent during screening.

10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study.

11. Participant has a BMI of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Madison University	Harrisonburg	Virginia	United States	22801

Sponsors and Collaborators

• Canopy Growth Corporation
• James Madison University

Investigators

• Principal Investigator: Jessica G Irons, PhD, James Madison University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Canopy Growth Corporation
• ClinicalTrials.gov Identifier: NCT05679830
• Other Study ID Numbers: MRS
• First Posted: Jan 11, 2023
• Last Update Posted: Jan 11, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Canopy Growth Corporation: cannabidiol; CBD; menstruation
• Additional relevant MeSH terms: Cannabidiol

Study Results

No Results Posted as of Jan 11, 2023