None listed
Conditions
Brief summary
This study will determine if there are any changes in sleep difficulties in relation to menopause, and other symptoms of menopause as well as looking at the rate of adverse events after using medicinal cannabis. This study will provide data for future clinical trials if potential benefits are found. We hypothesise that medicinal cannabis can improve sleep quality in relation to menopause, alongside other symptoms.
Interventions
Participants will be prescribed a type of medicinal cannabis (MC) as part of their participation in this study by a medicinal cannabis doctor via a telehealth appointment at the Natura Clinic. The medical doctor will assess if the participant is suitable for medicinal cannabis and will use the same criteria as for members of the general public wishing to use medicinal cannabis to manage period pain. The research team has no involvement in the allocation or dispensing of medicinal cannabis produc
Participants will be prescribed a type of medicinal cannabis (MC) as part of their participation in this study by a medicinal cannabis doctor via a telehealth appointment at the Natura Clinic. The medical doctor will assess if the participant is suitable for medicinal cannabis and will use the same criteria as for members of the general public wishing to use medicinal cannabis to manage period pain. The research team has no involvement in the allocation or dispensing of medicinal cannabis products and the decision to prescribe medicinal cannabis for the potential participant rests solely with the medical doctor. A specific type of MC, dose range and mode of administration will be individualised to each patient. MC products will be chosen by the MC doctor using the project formulary which includes cannabidiol (CBD) only products, delta-9-tetrahydrocannabinol (THC) dominant products and mixed CBD/THC products. The MC doctor will prescribe MC products based on pain experienced by the participant. Modes of administration include: flower products, vape (cartridge) and oils. The dose range and mode of administration will be prescribed by the MC doctor at the participant's baseline visit at the medicinal cannabis clinic. Over the course of the observation period the doctor can change dosage or product if required due to adverse events or lack of efficacy. Participants will use MC products for 6 months. Blood tests: Participants are to attend a Laverty Pathology (or sister site) collection centre for: full blood exam, liver function tests and kidney function tests including urea and electrolytes and hsCRP. These will be done at baseline, 3 months and 6 months. Each month, participants will be required to complete a series of questionnaires. Monitoring: Side effects will be tracked during study via monthly reporting by participants through REDCap. Participants will be advised to contact their treating medicinal cannabis doctor at Natura Clinic if they experience any serious side effects/adverse events. The modified COMM survey will be used to assess the participant for cannabis use disorder.
Sponsors
Cannim Group Pty Ltd
Eligibility
Sex/Gender
All
Age
45 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged between 45 and 55 years who meet criteria for perimenopause or postmenopausal status using the Stages of Reproductive Aging Workshop (STRAW+10) criteria. Perimenopause will include both early menopause transition (variability of 7 or more days in the menstrual cycle within 10 cycles of the first variable length cycle) and late menopause transition (amenorrhea for at least 60 days and increased variability in cycle length). Post menopause will be defined as 12 consecutive months without menstruation. 2. Women who reach a score of 14 or more on the Menopause Rating Scale (MRS), indicating the need of treatment for climacteric symptoms, are eligible for this study. 3. Results within normal ranges on screening pathology test: full blood exam, liver function tests, urea and electrolytes. 4. Women who are experiencing difficulties with sleep including either falling asleep or staying asleep.
Exclusion criteria
Participants will be excluded if they: 1. Have used medical or illicit cannabis within the past 2 months; and are unwilling to complete a 6-wash-out period from cannabis 2. Are enrolled in another active research project using an intervention for menopause symptoms; 3. Have been diagnosed with psychiatric affective and non-affective disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder; 4. Have started, stopped, or made significant changes to dosage of any menopause-related medication (including hormonal, any herbs or supplements) in the past 3 months; 5. Have used any recreational drugs in the preceding 3 months or significant current alcohol use (defined as history of alcohol or substance abuse or dependence within the past 2 years (and across the lifespan for cannabis and cannabis products), as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, or pattern of alcohol use over the last 3 months averaging in excess of 21 standard drinks per week or 4 standard drinks in any given day) 6. Have abnormal results on the screening pathology tests (full blood exam (FBE), liver function test (LFT), urea and electrolytes (U&E)).
Outcome results
None listed