Clinical trial NCT06831916: Impact of Cannabinoids on Menopause Symptoms
Official title: Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Perimenopause
Menopause
Keywords: Menopause
Perimenopause
Cannabinoids
CBG
CBD
Cognition
Anxiety
Sleep
Pain
Mood
Stress
Brain Fog
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: Terra Mater Botanicals Pty Ltd
First posted: 2025-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed description: This study implements a randomized, double-blind, placebo-controlled, observational field experiment design to examine the impact of hemp-derived minor cannabinoids on symptoms of menopause/perimenopause. The study will require 3 months to complete.

Healthy adult women (between the ages of 40-60) experiencing psychological and physical symptoms of menopause or perimenopause will be recruited via advertisements on social media, physicians' offices, in the community, at menopause conferences/conventions, and on internet forums. Prospective participants will complete a brief online screening survey to determine whether they meet eligibility requirements. Eligible participants will be asked to provide their first name and phone number if they want to be contacted via text message to participate.

Initial Zoom Session: Eligible participants who agree to participate will be asked to schedule an initial Zoom session, during which they will provide informed consent, review the study requirements, and complete cognitive tests including tests of memory and verbal fluency. Tests include the Rey Auditory Verbal Learning Test (RAVLT), FAS Verbal Fluency Test, Digit Span Forward and Backward (DSF, DSB), Deese-Roediger-McDermott Paradigm (DRM), Corsi Forward and Backward, and Prospective Memory (PM) Tasks. They will also be given the contact information for a company that manufactures and distributes hemp-derived cannabinoids. Participants will be asked to contact the company and request that they directly ship the product to them (the participant). The product will be provided at no cost to the participant (or to the PI or their lab). The PI will randomize each participant to the active or placebo condition and will subsequently contact the distributor to inform them of which product to ship (active or placebo). Participants will be given a link to an online Qualtrics survey that will be used to assess demographic characteristics, medications, and menopause/perimenopause symptoms, including depression, anxiety, perceived stress, physical and emotional health, insomnia, and everyday memory problems (Beck Depression Inventory \[BDI\], Beck Anxiety Inventory \[BAI\], Perceived Stress Scale \[PSS\], Short Form Health Survey \[SF-36\], Insomnia Severity Index \[ISI\], and Everyday Memory Questionnaire \[EMQ\], respectively).

Baseline: Participants will then complete four weeks of baseline assessments via ecological momentary assessment (EMA). Specifically, twice a day: shortly after they eat breakfast, and shortly after they eat dinner participants will complete a brief survey on their phone. For each EMA survey, they will be asked to indicate whether they experienced various emotional/psychological symptoms of menopause as well as whether they experienced various physical symptoms of menopause since their last EMA assessment. For each endorsed symptom, they will be asked to rate its severity as well as how much it interfered with their life using a 0 to 10 visual analog scale. In the morning survey, they will also be asked to indicate how well they slept the night before. Once a week, participants will also complete a series of EMA cognitive tests, including tests of verbal memory, spatial memory, working memory, inhibition, psychomotor speed, and attention (assessed using NeuroUX's Memory List, CopyKat, 2-Back, Digit Symbol Substitution, Color Names, Quick Tap Level 1and 2, and Trail Making A and B). Participants will be sent text messages with a link to the tests and will be instructed to complete them on their smartphone. At the end of the month, participants will meet a researcher over Zoom where they will complete additional cognitive tests (RAVLT, FAS, DSF/DSB, DRM, Corsi, PM). Cognitive tests involving word lists or letter sets (i.e., RAVLT, FAS, DRM) will be counterbalanced using a Latin Square design. At the end of the session, they will be sent a link to complete an online survey that will be used to assess menopause/perimenopause symptoms, including depression, anxiety, perceived stress, physical and emotional health, insomnia, and everyday memory problems (BDI, BAI, PSS, SF-36, ISI, EMQ, respectively). This period of time constitutes the baseline assessment period.

Phase 1: Phase 1 will begin after 4 weeks of baseline assessments and will continue for 4 weeks. During this phase, participants will be asked to take a single dose of the active or placebo version of the product (in a double-blind manner) twice a day (once after breakfast and again after dinner) and to complete EMA survey assessments twice a day (after orally ingesting each dose). Participants will be sent reminders and links via text message. For each EMA survey, they will be asked to indicate whether they took the study product, and if so what time they took the product. If they indicate they have not taken the product yet they will instructed to do so or provide a reason why they cannot do so. Next, they will be asked to indicate whether they experienced various emotional symptoms of menopause/perimenopause as well as whether they experienced various physical symptoms of menopause/perimenopause since their last EMA survey assessment. For each endorsed symptom, they will be asked to rate its severity as well as how much it interfered with their life using a 0 to 10 visual analog scale. In the morning survey, they will also be asked to indicate how well they slept the night before. Participants will also report on whether they experienced any side effects. Once a week, participants will also complete a series of EMA cognitive tests, including tests of verbal memory, spatial memory, inhibition, psychomotor speed, and attention (assessed using NeuroUX's Memory List, CopyKat, 2-Back, Digit Symbol Substitution, Color Names, Quick Tap Level 1and 2, and Trail Making A and B). Participants will be sent text messages with a link to the tests and will be instructed to complete them on their smartphone. At the end of the four weeks, participants will meet a researcher over Zoom where they will complete additional cognitive tests (RAVLT, FAS, DSF/DSB, DRM, Corsi, PM). They will also be asked if they would like to double the dose of the tincture for Phase 2 and additional product will be sent to participants who indicate they want to increase the dose. At the end of the session, they will be sent a link to complete an online survey that will be used to assess menopause/perimenopause symptoms, including depression, anxiety, perceived stress, physical and emotional health, insomnia, and everyday memory problems (BDI, BAI, PSS, SF-36, ISI, EMQ, respectively).

Phase 2: Phase 2 will begin after 4 weeks of phase 1 assessments and will continue for 4 weeks. During this phase, participants will be asked to take two doses of the active or placebo version of the product (in a double-blind manner) twice a day (once after breakfast and again after dinner) if they indicated they wanted to increase the dose of the product. Otherwise, they will continue taking a single dose twice a day. They will complete the same EMA survey assessments twice a day (after orally ingesting each dose). Participants will be sent reminders and links via text message. For each EMA survey they will be asked to indicate whether they took the study product, and if so what time they took the product. If they indicate they have not taken the product yet they will instructed to do so or provide a reason why they cannot do so. Next, they will be asked to indicate whether they experienced various emotional symptoms of menopause/perimenopause as well as whether they experienced various physical symptoms of menopause/perimenopause since their last EMA survey assessment. For each endorsed symptom, they will be asked to rate its severity as well as how much it interfered with their life using a 0 to 10 visual analog scale. In the morning survey, they will also be asked to indicate how well they slept the night before. Participants will also report on whether they experienced any side effects. Once a week, participants will also complete a series of cognitive tests using EMA, including tests of verbal memory, spatial memory, inhibition, psychomotor speed, and attention (assessed using NeuroUX's Memory List, CopyKat, 2-Back, Digit Symbol Substitution, Color Names, Quick Tap Level 1and 2, and Trail Making A and B). Participants will be sent text messages with a link to the tests and will be instructed to complete them on their smartphone. At the end of the four weeks, participants will meet a researcher over Zoom where they will complete additional cognitive tests (RAVLT, FAS, DSF/DSB, DRM, Corsi, PM). At the end of the session, they will be sent a link to complete the online survey (including the BDI, BAI, PSS, SF-36, ISI, and EMQ). The study ends after phase 2.

Eligibility criteria: Inclusion Criteria:

* designated female at birth
* 40-60 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

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

Primary outcomes:
measure: Depression Monthly Assessment: Beck Depression Inventory
timeFrame: 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.
measure: Anxiety Monthly Assessment: Beck Anxiety Inventory
timeFrame: 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.
measure: Perimenopausal Depression Monthly Assessment: Meno-D
timeFrame: 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.
measure: Emotional/Mental Symptoms Daily Assessment
timeFrame: 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:
measure: Physical Symptoms Daily Assessment
timeFrame: Physical symptoms will be assessed during each session (morning and night) of the daily EMA assessments, for the 3 month duration of the study.
measure: Side Effects Daily Assessment
timeFrame: Side effects will be assessed during each session (morning and night) of the daily EMA assessments, for the 3 month duration of the study.
measure: Verbal Memory Monthly Assessment: RAVLT
timeFrame: The RAVLT will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
measure: Verbal Fluency Monthly Assessment: FAS
timeFrame: 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.
measure: ST/Working Memory Monthly Assessment: Digit Span Forward and Backwards
timeFrame: 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.
measure: False Memory Monthly Assessment: Deese-Roediger-McDermott Paradigm
timeFrame: The false memory test will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
measure: ST/Working Spatial Memory Monthly Assessment: Corsi Forward and Backward
timeFrame: The Corsi tests will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
measure: Prospective Memory Monthly Assessment: Difficulty Ratings
timeFrame: The prospective memory tests will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
measure: Prospective Memory Monthly Assessment: Survey Completion
timeFrame: The prospective memory tests will be administered during monthly Zoom sessions, during four different sessions. They will occur at approximately week 1, 5, 9, and 13.
measure: Brain Fog Monthly Assessment: Everyday Memory Questionnaire
timeFrame: 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.
measure: Stress Monthly Assessment: Perceived Stress Scale
timeFrame: 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.
measure: Health Monthly Assessment: SF-36 Health Survey Questionnaire
timeFrame: 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.
measure: Sleep Monthly Assessment: Insomnia Severity Index
timeFrame: 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.
measure: Sleep Daily Assessment
timeFrame: Sleep quality will be assessed during each morning session of the daily EMA assessments, for the 3 month duration of the study.
measure: Verbal Memory Weekly Assessment: Memory List
timeFrame: Verbal memory will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Spatial Memory Weekly Assessment: CopyKat
timeFrame: Spatial memory will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Working Memory Weekly Assessment: 2-Back
timeFrame: Working memory will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Digit Symbol Substitution Weekly Assessment: Digit Symbol Task
timeFrame: Digit symbol substitution ability will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Simple Reaction Time Weekly Assessment: Quick Tap Level 1
timeFrame: Simple reaction time will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Working Memory/Attention Weekly Assessment: Color Names
timeFrame: "Color Names" performance will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Trail Making Test Weekly Assessment: A and B
timeFrame: Trail making ability will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
measure: Response Inhibition Weekly Assessment: Quick Tap Level 2
timeFrame: Response inhibition will be assessed during the weekly EMA cognitive assessments. Participants will be prompted to complete these games during their morning daily EMA session, for the 3 month duration of the study.
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Washington State University - Pullman Campus
state: Washington
Study officials:
References: