Impact of Cannabinoids on Menopause Symptoms

What this trial studies

The purpose of the study is to examine the impact of the hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.

Conditions in scope

• Perimenopause
• Menopause

Interventions

• Active Cannabinoid Product (Dietary Supplement) — Participants will be administered a product with minor cannabinoids and terpenes.
• Placebo (Other) — Participants will be administered a placebo.

Who can join

Women only · Ages 40 Years to 60 Years

Inclusion criteria

• designated female at birth
• years of age
• able to give informed consent (no intellectual disability)
• stable pharmacotherapeutic regimen, no change in the past 3 months
• abstinent from regular cannabis use (\<1x/month) for past year, and willing to abstain from use for 3 months
• abstinent for supplements, don't add any supplements (no changes in past 3 months)
• own a smartphone
• have access to Zoom on a secure, stable internet connection

Exclusion criteria

• currently taking anti-depressant, anti-anxiety, and/or antipsychotic medication
• severe depression, neurovegetative symptoms, or current suicidality
• psychosis or family history of psychosis
• pregnant or breastfeeding
• chemotherapy
• hypotension
• drug testing for work or other reasons
• illicit drug use in past 3 months (cannabis not illicit)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-03-03
• Primary completion: 2027-01-12
• Last update posted: 2025-04-04
• First posted: 2025-02-18

Sponsor & contact

Lead sponsor: Washington State University (Other)

Collaborators: Terra Mater Botanicals Pty Ltd

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Depression Monthly Assessment: Beck Depression Inventory (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 Beck Depression Inventory (BDI). Participants will complete the BDI 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 Inventory (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 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-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 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 Assessment (Emotional/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…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.