Information

Ethical Clearance Reference Number: HR/DP-23/24-40561
Invitation Paragraph
Hystelica, a research organisation dedicated to understanding safe and effective psychedelic use for women, is conducting this study to explore how microdosing psychedelics impacts menopause symptoms. This study is an important part of our research into female-specific psychedelic use. Before you decide whether you want to take part in this study, we ask you to read this Information Sheet so that you fully understand who can take part in the study, what your participation will involve, and why the research is being done. Please take time to read the following information carefully and discuss it with others if you wish. You may also contact one of the research team via the contact details provided if you require further explanation or have further questions.

PLEASE NOTE WE DO NOT PROVIDE ANY SUBSTANCES OR GUIDANCE AROUND DOSAGE/SUBSTANCES

What is a Microdose?
Microdosing psychedelics is a practise of taking a sub-perceptual (no perceivable transient of perceptual effects) by using very small doses of psychedelic compounds for a specific length of time, often in a specific regime. Some examples of psychedelic substances are psilocybin (magic mushrooms), LSD, ketamine, MDMA.

What is the purpose of the study?
The purpose of this study is to better understand how the mental and/or physical symptoms of the menopause are impacted by microdosing psychedelics in women who are going through the menopausal transition (peri-menopausal) or who have been through the menopausal transition (post-menopausal) who are planning to microdose psychedelics. As the use of psychedelics, including microdosing psychedelics, for their potentially medicinal properties gains increased attention, it is of paramount importance to explore their interactions with the menopause to ensure their safety and effectiveness for women going through this life transition.

Why have I been invited to take part?
You are being invited to participate in the study because you are a female who is currently going through the menopausal transition (peri-menopausal) or who has gone through the menopausal transition (post-menopausal) who is planning to use psychedelic substances in sub-perceptual doses to manage symptoms related to the menopause.

To take part in the study you must:
● Be at least 18 years old
● Have a good understanding of English
● Not have taken any psychedelics substances (including ketamine and MDMA, but excluding cannabis) for at least 2 weeks prior to starting the microdosing regime
● Provide us with a correct email address and consent to being contacted during the research period, via email, for the purpose of data collection.
What will happen if I take part?
If you choose to take part you will first complete an eligibility survey that will ask for some personal information, consent to take part in the study and consent to share your contact details for the purpose of data collection during the research period. The questions asked in this first survey will assess your eligibility for the study If you do not meet the eligibility criteria you will be notified of this at the end of the first survey and you will receive no further surveys. Any data you have provided will be deleted. If you do meet the eligibility criteria, you will be sent a second survey to complete prior to the start of your planned microdosing regimen (regimen start date will be based on disclosed information in eligibility survey) to measure your baseline menopause symptoms. Once you start your planned microdosing regimen, the study will start.

During the study, you will complete online surveys about your menopause symptoms and your mental and physical health, either on your computer or smartphone. These surveys will be sent to you automatically at established check-in points. The assessment period of the experiment lasts 12 weeks and you will receive surveys to complete at the following timepoints: baseline assessment soon after recruitment, a check-in survey 1 week after your reported regimen start, a check-in survey 6 weeks after your reported regimen start and a final check-in at 12 weeks after your reported regimen start. In all surveys you will be asked if you have have made any changes to or have stopped your personal regimen. We ask you to continue to participate in the check-ins regardless of changes to your personal regimen, unless you decide to withdraw from the study completely.

We expect that the eligibility survey will take around 15 minutes to complete, the second survey around 20-25 minutes and the following surveys around 25-30 minutes. The final follow-up survey (at 12 weeks) will include end of study questions and will take around 45 minutes to complete. Some examples of questions you will be asked throughout the study are: “During the past X weeks, how satisfied have you been with the ability of the study medication to control your hot flashes during the day?”, “How has your motivation/interest/enthusiasm been over the past month?”, “ 4. How SATISFIED/DISSATISFIED are you with your CURRENT sleep pattern?” etc. There will be an even wider range of questions asking about your mental and physical health and how microdosing psychedelics may have impacted many areas of your life throughout the study. Full participation in the research study will take about 12 weeks from your reported regimen start date to the final online follow-up survey.
Do I have to take part?
Participation is completely voluntary. You should only take part if you want to and choosing not to take part will not disadvantage you in any way. If you choose to take part you will be asked to provide your consent. To do this you will be asked to indicate that you have read and understand the information provided and that you consent to your anonymous data being used for the purposes explained.

You are free to withdraw at any point during the study. If you are completing sign-up you only need to close your browser tab to withdraw, and if you have given your contact details and consented to take part in the full study you will need to email the researchers in order to withdraw your participation. At no point will you need to provide an explanation for withdrawing. Withdrawing from the study will not affect you in any way. We are unable to withdraw your anonymous surveys from the study after completion. Please do not include any personal identifiable information in your responses except for when contact details are asked for.

Incentives
By participating in and completing this survey, you will be given an opportunity to enter into a prize draw in order to win one of three £50 Amazon gift vouchers awarded 14 days after the last participant has completed their last survey.

What are the possible risks of taking part?
Participating in this survey might involve being confronted with uncomfortable questions about your own body and menstrual cycle. The survey will also pertain to menopause, which can be a difficult topic for some as it can be a challenging time in a woman’s life. Furthermore, you will be asked to disclose previous diagnoses, which might bring up painful memories. You will be provided with mental health resources and helplines before starting the study, and we will include these resources in every survey you complete. Feel free to contact these resources at any point during the process of participating should it feel needed. You are also free to stop participating in the study at any point by closing the window in your browser (before recruitment) or contacting the researchers (after recruitment). There is also a risk of disclosing illegal activity, such as obtaining and using psychedelic substances. However, there will be no follow-up in the event of such a disclosure, as the research team will not be able to connect information disclosed in surveys to participant identifiable data. Helplines and charities to help with challenges regarding such a disclosure will be easily accessible in all surveys if it should be needed.
What are the possible benefits of taking part?
You will have the opportunity to contribute to the advancement of research on microdosing psychedelics for people experiencing menopausal symptoms by sharing your experiences and perspectives. We intend to make all our findings available publicly to inform the growing number of women experiencing menopause and considering the use of microdoses of psychedelics. However, there are no anticipated direct benefits to participants.

Data handling and confidentiality
Although the research and questionnaire completion is anonymous we will be asking for you to share your contact details to be contacted through out the study as explained above. These personal details will be completely separate from the research outputs and impossible to link to other information provided. These details will be held on a King’s College London server. They will be connected to a self-generated ID that only you will know but that will allow us to connect your survey responses across timepoints without connecting you to any identifying information. This means that nobody, including the researchers, will be aware of your identity, and that nobody will be able to connect you to the answers you provide, even indirectly. Your answers will nevertheless be treated confidentially and the information you provide will not allow you to be identified in any research outputs/publications. Your data will be held securely on a verified database within King’s College London systems in an electronic format (SharePoint) and will be retained until analyses have been conducted, after which the data will be deleted. The date for data deletion will be 07/01/2026.

Any personal data collected independently of the anonymous survey as described elsewhere in this Information Sheet will be processed under the terms of UK data protection law (including the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018). If you would like more information about how your data will be processed under the terms of UK data protection laws please visit the links below:

https://www.surveymonkey.co.uk/mp/privacy/
https://www.kcl.ac.uk/research/support/research-ethics/kings-college-london-statement-on-use-of-personal-data-in-research

King’s College London has a responsibility to keep information collected about you safe and secure, and to ensure the integrity of research data. Specialist teams within King’s College London continually assess and ensure that data is held in the most appropriate and secure way.
How is the project being funded?
This study is being funded by Hystelica and public donations made through the Multidisciplinary Association of Psychedelics (MAPS) fiscal sponsorship scheme.

What will happen to the results of the study?
The results of the project will be summarised in a published research article. You will be able to obtain a copy of the published research by opting into receiving further results at the end of the study in a separate survey which will not link you to information you provide in the present survey. The data itself will not be made publicly available, only the summary of the data analysis and the results found.

What if I have further questions, or if something goes wrong?
If this project has harmed you in any way or if you wish to make a complaint about the conduct of the project you can contact King's College London using the details below for further advice and information:

Name: Dr Grace Blest-Hopley
Email: grace.blest-hopley@kcl.ac.uk

Or, you can contact:
The Chair
Health Faculties RESC
rec@kcl.ac.uk

Thank you for reading this Information Sheet and for considering taking part in this research.
If you have found anything covered in this text distressing, please see the links to the following charities and helplines below:

Psychedelic harm reduction: https://www.psycareuk.org/

Narcotics Anonymous
0300 999 1212
ukna.org
Support for anyone who wants to stop using drugs.

Wellbeing of Women Charity: https://www.wellbeingofwomen.org.uk/

Women’s Health Charity: https://www.womens-health-concern.org/

Menopause Charity: https://www.themenopausecharity.org/

Alcoholics Anonymous (AA)
0800 9177 650
help@aamail.org (email helpline)
alcoholics-anonymous.org.uk
Help and support for anyone with alcohol problems.

Talk to Frank
0300 123 6600
talktofrank.com
Confidential advice and information about drugs, their effects and the law.

turning-point.co.uk

Marijuana Anonymous
0300 124 0373
helpline@marijuana-anonymous.org.uk
marijuana-anonymous.co.uk
Help for anyone worried about cannabis use.