Informed Consent #
Study Title: Double-blind randomized cross-over study of Psilocybe with and without 5-MeO-DMT enrichment: feels different?
This is how you agree to join the study. If you are curious, please read this consent agreement carefully before you decide to participate.
Introduction: In September 2021, attorney Ian Benouis tried growing a new type of psychoactive mushroom. He gave it to several spiritually inclined people who use psychedelics, and some of them judged it to be an important new psychoactive. Benouis and his collaborator, Greg Lake, called this fungi “psilomethoxin.” However, some who tried a sample didn’t feel it was any different from regular magic mushrooms (psilocybin/psilocin). While others discerned no noticeable subjective effect at all.
Purpose of the research study: This study will investigate whether people can tell the difference between psilomethoxin and regular magic mushrooms in a blinded condition.
What you will do in the study:
- You will complete a demographic questionnaire.
- You will attend a PSILO Temple soundbath and receive 1g of psilomethoxin instead of psilocybin.
- In a set of two subsequent soundbaths, you will receive either 1g of psilomethoxin or 1.5g of psilocybin in random order. After each soundbath, you will be asked to complete a survey that will take less than 10 minutes.
- This is not a micro-dose study.
- You can discontinue this study at any time.
Time required: The demographic questionnaire will take less than 10 minutes. You are required to attend three PSILO Temple soundbath ceremonies.
Risks:
- The Church of Sacred Synthesis has distributed at least 500,000 doses of psilomethoxin without any report of an adverse event. However, psilomethoxin is a new substance with only 2-3 years of anecdotal safety data. Research is ongoing, but little about the substance is known for certain. Until we learn more, it is prudent to regard contraindications for 5-MeO-DMT as contraindications for psilomethoxin. The contraindications include epilepsy, CYP2D6 inhibitors, MAO inhibitors, serotonin reuptake inhibitors, lithium, or pregnancy.
- There is a small risk of loss of confidentiality since we require your name, email address, and mobile phone number to communicate survey invitations. To minimize this risk, all information will be stored in password protected computers and transferred via encrypted channels. Within one month after the completion of data collection, identifying information will be destroyed.
Benefits:
- This study may help establish that psilomethoxin has different subjective effects compared to regular magic mushrooms. We expect this will spur research and lead to many further benefits.
- You may find the use of psilomethoxin personally rewarding and may enjoy continuing to access this substance.
- Anonymized data will be archived on a freely accessible website, available for other researchers to analyze, furthering scientific progress.
Costs: There is no cost for participating in this study other than your time investment.
Confidentiality: Potentially identifiable information about you consists of your name, email address, and mobile phone number (if provided). These data will be stored in a password protected computer and only transmitted over encrypted channels. Within one month after the completion of data collection, these data will be destroyed, rendering these data de-identified.
Voluntary participation and withdrawal: Your participation in this study is voluntary. You may decide to not participate in this study. Your decision not to take part will involve no penalty or loss of benefits to which you are otherwise entitled.
Questions: If you have any questions, complaints, or concerns about your participation in this research, contact:
Joshua Pritikin <[email protected]>
Mobile#: 458-272-3537
The researcher/study staff named above is the best person(s) to contact for questions about your participation in this study. If you have any general questions about your rights as a participant in this research, you may contact:
Interfaith Review Board <[email protected]>
Contact this email to express concerns or complaints about the research or research team. You may also use this email if you cannot reach the research team or if you wish to talk with someone else.
By clicking ‘agree’, I affirm that I have read this consent, am 18 years or older, and agree to participate in this study.