Clinical trial NCT05679830: The Effects of CBD Isolate on Menstrual-Related Symptoms
Official title: A Randomized, Open-Label Trial on the Effects of Cannabidiol Isolate on Menstrual-Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menstrual Discomfort
Keywords: cannabidiol
CBD
menstruation
Lead sponsor: Canopy Growth Corporation
Sponsor class: INDUSTRY
Collaborators: name: James Madison University
First posted: 2023-01-11
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Menstrual-Related Symptoms Questionnaire (MRSQ)
timeFrame: 1 menstrual cycle/1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Harrisonburg
country: United States
facility: James Madison University
state: Virginia
Study officials:
affiliation: James Madison University
name: Jessica G Irons, PhD
role: PRINCIPAL_INVESTIGATOR
References: