Impact of Cannabinoids on Menopause Symptoms
NCT06831916, Phase 2, Completed, Washington State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Cannabinoids on Menopause Symptoms | ClinicalTrials.gov |
| NCT number | NCT06831916 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 104 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Washington State University | ClinicalTrials.gov |
| Conditions | Perimenopause, Menopause | ClinicalTrials.gov |
| Interventions | Active Cannabinoid Product, Placebo | ClinicalTrials.gov |
| First posted | 2025-02-18 | ClinicalTrials.gov |
| Last updated | 2026-06-02 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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 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). | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | 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. | 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. | ClinicalTrials.gov |
| Secondary | False Memory Monthly Assessment: Deese-Roediger-McDermott Paradigm | 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. | 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. | ClinicalTrials.gov |
| Secondary | ST/Working Spatial Memory Monthly Assessment: Corsi Forward and Backward | 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. | 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. | ClinicalTrials.gov |
| Secondary | Prospective Memory Monthly Assessment: Difficulty Ratings | 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. | 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. | ClinicalTrials.gov |
| Secondary | Prospective Memory Monthly Assessment: Survey Completion | 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. | 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. | ClinicalTrials.gov |
| Secondary | Brain Fog Monthly Assessment: Everyday Memory Questionnaire | 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 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. | ClinicalTrials.gov |
| Secondary | Stress Monthly Assessment: Perceived Stress Scale | 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 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. | ClinicalTrials.gov |
| Secondary | Health Monthly Assessment: SF-36 Health Survey Questionnaire | 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 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. | ClinicalTrials.gov |
| Secondary | Sleep Monthly Assessment: Insomnia Severity Index | 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 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. | ClinicalTrials.gov |
| Secondary | Sleep Daily Assessment | Sleep quality will be assessed during each morning session of the daily EMA assessments, for the 3 month duration of the study. | 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. | ClinicalTrials.gov |
| Secondary | Verbal Memory Weekly Assessment: Memory List | 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. | 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. | ClinicalTrials.gov |
| Secondary | Spatial Memory Weekly Assessment: CopyKat | 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. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 12
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 2-Back Task | Secondary outcome | ConductCognition |
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| DRM False Memory Task | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)