Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorWashington State University
About this trial
The purpose of the study is to examine the impact of hemp-derived minor cannabinoids on symptoms of menopause/perimenopause.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hemp-derived cannabinoids
DrugParticipants will be administered a legal product with hemp-derived cannabinoids and terpenes.
Placebo
DrugParticipants will be administered a placebo
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Placebo ArmPlacebo comparator 1 intervention
Group B: Active ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depression Monthly Assessment: Center for Epidemiologic Studies Depression Scale (CES-D)
At the end of each monthly Zoom session, participants will be sent a survey link including the Center for Epidemiologic Studies Depression Scale (CES-D). Participants will complete the CES-D after each zoom session, including the first session, the baseline session after four week, and after both phase 1 and phase 2.
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 13.2
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.
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 13.3
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.
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 13.4
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)
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.Secondary outcomes
1
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).
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 study2
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.
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.3
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.
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 13.4
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington State University
Lead sponsor
Terra Mater Botanicals Pty Ltd
Collaborator
Source ClinicalTrials.gov