Hemp-Derived Cannabinoids for Menopause Symptoms
This study is looking at how hemp-derived cannabinoids, a legal product with cannabinoids and terpenes, might affect symptoms of menopause and perimenopause. Researchers want to see if these cannabinoids can help with depression, anxiety, and other perimenopausal depression symptoms. You might be able to join if you are a woman between 40 and 60 years old, designated female at birth, and are experiencing menopause or perimenopause symptoms. To be eligible, you also need to have a stable medication routine and not have used cannabis regularly in the past year. The study is currently recruiting 104 participants, but its overall status is unclear. The main goal is to measure changes in depression and anxiety using specific surveys over about 13 weeks.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning you would either receive the hemp-derived cannabinoids or a placebo (an inactive substance), and neither you nor the researchers would know which one. It plans to enroll 104 participants.
- What's involved
- You would participate in a 3-month study, which includes an initial Zoom session for consent and cognitive tests. You would also complete monthly surveys after Zoom sessions at approximately weeks 1, 5, 9, and 13.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depression, anxiety, and perimenopausal depression symptoms will be assessed monthly for approximately 13 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Depression Monthly Assessment: Center for Epidemiologic Studies Depression Scale (CES-D)The survey will be completed shortly after the monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
At the end of each monthly Zoom session, participants will be sent a survey link including the Center for Epidemiologic Studies Depression Scale (CES-D). Participants will complete the CES-D after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
- Anxiety Monthly Assessment: Beck Anxiety InventoryThe survey will be completed shortly after the monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
At the end of each monthly Zoom session, participants will be sent a survey link including the Beck Anxiety Inventory (BAI). Participants will complete the BAI after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
- Perimenopausal Depression Monthly Assessment: Meno-DThe survey will be completed shortly after the monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
At the end of each monthly Zoom session, participants will be sent a survey link including the Meno-D. Participants will complete the Meno-D after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
- Emotional/Mental Symptoms Daily AssessmentEmotional/mental symptoms will be assessed during each session (morning and night) of the daily EMA assessments, for the 3 month duration of the study.
During each EMA session (twice daily), participants will be asked to indicate emotional/mental symptoms they have experienced since the last time they completed the survey. Possible symptoms include: new or worsening anxiety; new or worsening depression/crying; loss of interest in most things; fatigue or loss of energy; diminished self-esteem; mood swings; irritability; brain fog. They will also have the opportunity to write in other symptoms experienced. For each endorsed symptom, participants will be asked to rate the severity (on a 0 to 10 visual analog scale) and the degree to which that symptom interferes with their life (on a 0 to 10 visual analog scale)