PerimenopausePhase 2NCT06831916
Impact of Cannabinoids on Menopause Symptoms
A Phase 2 study testing Active Cannabinoid Product in people with Perimenopause and Menopause, run by Washington State University at 1 site in United States.
Trial summary
The purpose of the study is to examine the impact of the hemp-derived minor cannabinoids on symptoms of menopause/perimenopause. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Perimenopause, Menopause
- What is being tested?
- Active Cannabinoid Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- own a smartphone
- have access to Zoom on a secure, stable internet connection
- perimenopausal or menopausal
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University - Pullman Campus
Pullman, Washington, 99163
About this study
Official title: Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
The purpose of the study is to examine the impact of the hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.
Read the 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.
- Conditions
- Perimenopause, Menopause
- Being tested
- Active Cannabinoid Product, Placebo
- Keywords
- Menopause, Perimenopause, Cannabinoids, CBG, CBD, Cognition, Anxiety, Sleep, Pain, Mood, Stress, Brain Fog
- Medical subject headings
- Anxiety Disorders, Pain, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cannabinoid ProductDietary supplement
Participants will be administered a product with minor cannabinoids and terpenes.
PlaceboOther
Participants will be administered a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Participants in this arm will receive a placebo. Receives: Other: Placebo |
| Active Arm | Experimental | Participants in this arm will receive an active product. Receives: Dietary Supplement: Active Cannabinoid Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
During each EMA session (twice daily), participants will be asked to indicate physical symptoms they have experienced since the last time they completed the survey. Possible symptoms include: hot flushes/flashes or night sweats; headaches/migraines; feeling dizzy or faint; muscle or joint pain or weakness; breast tenderness or pain; heart palpitations or a racing heart; vaginal dryness or pain; urinary frequency, urgency, leaking, and/or urinary tract infections. 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).
High-risk responses (i.e., severe symptoms) will alert the PI and relevant resources/information will be provided.
Measured: 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
During each EMA session (twice daily), participants will be asked to indicate any side effects they have experienced since the last time they completed the survey. Possible side effects include: dry eyes; dry mouth; dizziness, sleepiness or fatigue, increased appetite, racing heart or heart palpitations, anxiety, feeling intoxicated; feeling impaired; and difficulty urinating.
Measured: 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
Participants will complete the Rey Auditory Verbal Learning Test (RAVLT) at each monthly assessment. The RAVLT will be administered via Zoom by a research assistant at the beginning of the study, after four weeks of a baseline phase, and at the end of both phase 1 and phase 2. Four alternate versions will be administered in a counterbalanced manner.
Measured: 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
Participants will complete a verbal fluency assessment at each monthly assessment. The FAS verbal fluency test will be administered via Zoom by a research assistant at the beginning of the study, after four weeks of a baseline phase, and at the end of both phase 1 and phase 2. Four alternate letter sets will be administered in a counterbalanced manner.
Measured: 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
Participants will complete the digit span forward and backward tests at each monthly assessment. The test will be administered via Zoom by a research assistant at the beginning of the study, after four weeks of a baseline phase, and at the end of both phase 1 and phase 2.
Measured: 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.
False Memory Monthly Assessment: Deese-Roediger-McDermott Paradigm
Participants will complete the Deese-Roediger-McDermott Paradigm false memory test at each monthly assessment. The test will be administered via Zoom by a research assistant at the beginning of the study, after four weeks of a baseline phase, and at the end of both phase 1 and phase 2. Four alternate versions will be administered in a counterbalanced manner.
Measured: 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.
ST/Working Spatial Memory Monthly Assessment: Corsi Forward and Backward
Participants will complete the Corsi block-tapping tests (forward and backward) at each monthly assessment. The test will be administered via Zoom by a research assistant at the beginning of the study, after four weeks of a baseline phase, and at the end of both phase 1 and phase 2.
Measured: 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.
Prospective Memory Monthly Assessment: Difficulty Ratings
At each monthly Zoom session, participants will be asked to try to remember to rate the difficulty of each cognitive test completed during the session immediately after completing each test. Instructions and a 0 through 10 visual analog scale will be provided at the beginning of the session. Participants will not be reminded to provide ratings.
Measured: 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.
Prospective Memory Monthly Assessment: Survey Completion
At the end of each monthly Zoom session, participants will be sent a survey link and will be asked to email the RA once they have completed the survey. Instructions and the RA's email address will be provided immediately before sending the survey link and logging off of Zoom. Participants will not be reminded to email the RA.
Measured: 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.
Brain Fog Monthly Assessment: Everyday Memory Questionnaire
At the end of each monthly Zoom session, participants will be sent a survey link including the Everyday Memory Questionnaire (EMQ). Participants will complete the EMQ after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
Measured: 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.
Stress Monthly Assessment: Perceived Stress Scale
At the end of each monthly Zoom session, participants will be sent a survey link including the Perceived Stress Scale (PSS). Participants will complete the PSS after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
Measured: 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.
Health Monthly Assessment: SF-36 Health Survey Questionnaire
At the end of each monthly Zoom session, participants will be sent a survey link including the SF-36 Health Survey Questionnaire. Participants will complete the SF-36 after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
Measured: 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.
Sleep Monthly Assessment: Insomnia Severity Index
At the end of each monthly Zoom session, participants will be sent a survey link including the Insomnia Severity Index (ISI). Participants will complete the ISI after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
Measured: 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.
Sleep Daily Assessment
During each morning EMA session, participants will be asked to rate how well they slept the previous night on a 0 to 10 visual analog scale.
Measured: Sleep quality will be assessed during each morning session of the daily EMA assessments, for the 3 month duration of the study.
Verbal Memory Weekly Assessment: Memory List
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Memory List" game, assessing verbal memory. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Spatial Memory Weekly Assessment: CopyKat
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "CopyKat" game, assessing spatial memory. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Working Memory Weekly Assessment: 2-Back
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "2-Back" game, assessing working memory. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Digit Symbol Substitution Weekly Assessment: Digit Symbol Task
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Digit Symbol Task" game, assessing processing speed, and attention. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Simple Reaction Time Weekly Assessment: Quick Tap Level 1
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Quick Tap Level 1" game, assessing simple reaction time. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Working Memory/Attention Weekly Assessment: Color Names
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Color Names" game (i.e., Stroop test) assessing executive functioning (inhibitory control). The total cognitive assessment is designed to take around 15 minutes.
Measured: "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.
Trail Making Test Weekly Assessment: A and B
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Trail Making A" game (letter sequencing) and "Trail Making " game (letter-number alternating sequencing) assessing attention and cognitive flexibility (B). The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Response Inhibition Weekly Assessment: Quick Tap Level 2
During the weekly EMA cognitive assessments, participants will complete NeuroUX's "Quick Tap Level 2" game (i.e., Go-No-Go), inhibitory control. The total cognitive assessment is designed to take around 15 minutes.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start3 Mar 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Cuttler, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831916
- Sponsor's protocol ID
- 20779-001
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon request and after publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
- ClinicalTrials.gov ID
- NCT06831916
- Acronym / sponsor ID
- 20779-001
- Conditions
- Perimenopause, Menopause
- Keywords
- Menopause, Perimenopause, Cannabinoids, CBG, CBD, Cognition, Anxiety, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Other: PlaceboParticipants in this arm will receive a placebo. |
| Active Arm | Experimental | Dietary Supplement: Active Cannabinoid ProductParticipants in this arm will receive an active product. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Cannabinoid ProductParticipants will be administered a product with minor cannabinoids and terpenes. | Dietary supplement | Active Arm |
| PlaceboParticipants will be administered a placebo. | Other | Placebo Arm |
Primary outcome
Depression Monthly Assessment: Beck Depression Inventory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 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).
22 secondary outcomes
Physical Symptoms Daily Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
False Memory Monthly Assessment: Deese-Roediger-McDermott Paradigm
Time frame: 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.
ST/Working Spatial Memory Monthly Assessment: Corsi Forward and Backward
Time frame: 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.
Prospective Memory Monthly Assessment: Difficulty Ratings
Time frame: 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.
Prospective Memory Monthly Assessment: Survey Completion
Time frame: 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.
Brain Fog Monthly Assessment: Everyday Memory Questionnaire
Time frame: 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.
Stress Monthly Assessment: Perceived Stress Scale
Time frame: 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.
Health Monthly Assessment: SF-36 Health Survey Questionnaire
Time frame: 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.
Sleep Monthly Assessment: Insomnia Severity Index
Time frame: 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.
Sleep Daily Assessment
Time frame: Sleep quality will be assessed during each morning session of the daily EMA assessments, for the 3 month duration of the study.
Verbal Memory Weekly Assessment: Memory List
Time frame: 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.
Spatial Memory Weekly Assessment: CopyKat
Time frame: 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.
Working Memory Weekly Assessment: 2-Back
Time frame: 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.
Digit Symbol Substitution Weekly Assessment: Digit Symbol Task
Time frame: 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.
Simple Reaction Time Weekly Assessment: Quick Tap Level 1
Time frame: 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.
Working Memory/Attention Weekly Assessment: Color Names
Time frame: "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.
Trail Making Test Weekly Assessment: A and B
Time frame: 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.
Response Inhibition Weekly Assessment: Quick Tap Level 2
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request and after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Cannabinoid Product in people with Perimenopause and Menopause, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Monthly Assessment: Beck Depression Inventory (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.