The Effects of CBD Isolate on Menstrual-Related Symptoms

Menstrual Discomfort Clinical Trial

Official title:

A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679830
• Other study ID #: MRS
• Status: Completed
• Phase: Phase 2
• Start date: September 23, 2020
• Est. completion date: September 23, 2021

Study information

• Verified date: December 2022
• Source: Canopy Growth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Menstrual Discomfort

Intervention

Drug:
• Cannabidiol
Cannabidiol is a non-psychoactive cannabinoid obtained from the cannabis plant.

Locations

Country	Name	City	State
United States	James Madison University	Harrisonburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Canopy Growth Corporation	James Madison University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual-Related Symptoms Questionnaire (MRSQ)	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.	1 menstrual cycle/1 month