Impact of Cannabinoids on Menopause Symptoms

NCT06831916 | Recruiting Phase 2 DMC

• 1 other identifier: 20779-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perimenopause; Menopause

Keywords

Menopause; Perimenopause; Cannabinoids; CBG; CBD; Cognition; Anxiety; Sleep; Pain; Mood; Stress; Brain Fog

Outcome Measures

Primary Outcomes (4)

• Depression Monthly Assessment: Beck Depression Inventory

  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.

  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.

• Anxiety Monthly Assessment: Beck Anxiety Inventory

  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.

  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.

• Perimenopausal Depression Monthly Assessment: Meno-D

  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.

  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.

• Emotional/Mental Symptoms Daily Assessment

  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).

  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.

Secondary Outcomes (22)

• Physical Symptoms Daily Assessment

  Physical symptoms will be assessed during each session (morning and night) of the daily EMA assessments, for the 3 month duration of the study.

• Side Effects Daily Assessment

  Side effects will be assessed during each session (morning and night) of the daily EMA assessments, for the 3 month duration of the study.

• Verbal Memory Monthly Assessment: RAVLT

  The RAVLT will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.

• Verbal Fluency Monthly Assessment: FAS

  The FAS verbal fluency test will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.

• ST/Working Memory Monthly Assessment: Digit Span Forward and Backwards

  The digit span tests will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Participants in this arm will receive a placebo.

Other: Placebo

Active Arm

EXPERIMENTAL

Participants in this arm will receive an active product.

Dietary Supplement: Active Cannabinoid Product

Interventions

Active Cannabinoid Product DIETARY_SUPPLEMENT

Participants will be administered a product with minor cannabinoids and terpenes.

Active Arm

Placebo OTHER

Participants will be administered a placebo.

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• perimenopausal or menopausal

You may not qualify if:

• 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)
• heavy alcohol use (4 drinks more than 4x/week)
• international/air travel planned for more than one week in the next 3 months

Sponsors & Collaborators

• Washington State University: lead
• Terra Mater Botanicals Pty Ltd: collaborator

Study Sites (1)

Washington State University - Pullman Campus

Pullman, Washington, 99163, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain; Mental Fatigue

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatigue; Behavioral Symptoms; Behavior

Central Study Contacts

Carrie Cuttler, Ph.D., Psychology

CONTACT

(509) 592-0151; carrie.cuttler@wsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research assistants who administer the protocol will be masked.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 18, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified data will be retained indefinitely.
• Access Criteria: Researchers wanting to conduct secondary data analysis following my own publication.

Locations

US (1)