Psychedelics such as psilocybin have shown exceptional promise in treating a diverse array of mental illnesses ranging from anxiety (Grob et al., 2011) to depression (Ross et al., 2016) and substance use (Johnson, Garcia-Romeu, Cosimano, & Griffiths, 2014), but the effects of microdosing are still poorly understood. This project will generate important knowledge to contribute to our understanding of the effects of microdosing.
*The contents of this article were taken from the application of researchers Thomas Anderson & Rotem Petranker in their formal submission of their study to participate in the Catalyst launch. Texts have been simplified and shortened for the purposes of this post.
The University of Toronto Mississauga’s Psychedelic Science Research Program is looking to raise funding for it’s latest research project through Molecule Catalyst as a platform. This funding will go to a rigorous, high-impact clinical trial to study the effects of microdosing psilocybin, the primary psychedelic compound found in ‘magic’ mushrooms, to improve cognitive function and to alleviate negative mood symptoms. The trial will employ an advanced placebo-controlled design to identify whether microdosing psychedelics provide similar effects compared to the ones at higher doses.
“Microdosing is the practice of regularly consuming sub-hallucinogenic quantities of psychedelic substances.”
The primary research targets are:
Several other constructs identified in previous research will also be measured, such as:
- Social connection
and will result in a rich source of exploratory analyses that will provide a critical precedent for legal, responsible, and impactful psychedelics research.
The study is expected to kick off data collection in January 2020 and will continue for 1–1.5 years with 10 cohorts of 10 participants per cohort. Thomas Anderson & Rotem Petranker make up the power duo team leading the study with a diverse support network of expert scientific advisors covering psychology, clinical science, pharmacy, and psychiatry, including Prof. Dan Ariely and Dr. James Fadiman.
Background & Significance
Despite growing interest in both public and scientific communities, there is no evidence demonstrating a reliable causal relationship between microdosing and its purported benefits.
Concerningly, there is also no evidence describing the safety or efficacy of microdosing practices. To address this gap between positive public appeal and limited research evidence, the scientific team proposes the world’s first clinical trial on psilocybin microdoses using pharmaceutical grade psilocybin.
“This project will provide the first Open Science, hypothesis-driven, quantitative study of microdosing efficacy on a variety of commonly purported benefits and safety concerns.”
What sets this study apart:
- Open science
- Clinical grade psilocybin
- Controlled testing environment (not self-administered informal reporting)
- High-quality data collection
- Double-blind testing
One crucial aspect of their work that sets this study apart is the use of Open Science and pre-registration. In short, pre-registration is the most robust way to do science, the way the team believes it should be done. It holds scientists to the highest standard in the field as hypotheses and analyses need to be locked in beforehand, demonstrating a commitment to scientific integrity and intellectual honesty. We hope that the use of Open Science will stand as the gold standard for other psychedelic researchers to strive for (see this piece on The Conversation for more on this).
Why should you care?
Mental illness affects 20% of children and adolescents worldwide, and nearly 300 million people globally are suffering from Major Depressive disorder, with a recorded 800,000 suicides recorded each year.
Mounting evidence suggests psilocybin, a natural psychedelic compound, can introduce neuroplasticity in treatment-resistant depression (Carhart-Harris et al., 2017). Psychedelics may also promote openness, curiosity, and creative thinking (Anderson et al., 2019a, 2019b; Prochazkova et al., 2018).
Microdosing research is particularly important given the disparity between the prevalence of mental illnesses such as depression and anxiety and the resources to address acute phase mental illness, and this problem in itself is becoming a trillion-dollar issue.
Who will be participating in the study?
*Participants will be thoroughly screened to ensure that the sample includes healthy, low-risk participants who fit a profile of subclinical persistent depressive and/or anxiety disorders that may be addressed by the intervention. A detailed medical history will be reviewed by a physician and current medication use will be reviewed by a pharmacist. A psychiatrist will be on-call to ensure participant safety throughout the duration of the study.
How will they do it?
The study will be using a randomized, double-blind clinical “crossover washout design” (see explainer graphic below) that is run over an 8 week period.
- What this means is that on the first day, participants will be randomized into 4 weeks of either: i) weekly consumption of a placebo or ii) weekly microdoses of psilocybin (3mg).
- After 4 weeks, groups will “cross over”, i.e. the placebo-first group will begin receiving psilocybin and the psilocybin-first group will receive a placebo.
Having some participants receive psilocybin before the placebo allows us to assess whether beneficial effects “wash out” over the subsequent 4-week placebo period.
What will come from this study?
The community can expect that all data gathered and materials used will be made open source.
This includes the release of open access papers, presentations of the findings in conferences and knowledge mobilization pieces.
The team aims to develop a multi-study follow-up plan using data collected from this study, including studies on treatment for specific indications using novel investigations into neural mechanisms and possible drug development pathways for psilocybin-related derivatives. If all goes well, the team can begin running the next frontier of psychedelic research far ahead of anyone else in the world.
Next steps & Support
This is only the first project to be added to Molecule Catalyst, and other exciting announcements are to follow in the areas of Biogerontology (Aging & Longevity) as well as in Rare Diseases.
YOU can play an active role in helping this scientific study becoming a reality.
We would love to get support and feedback from the community and there are many different ways for you to get involved!
In just a few short weeks you’ll be able to actively donate to campaigns like the above project on our platform using Dai.
- If you’re interested in diving deeper into how our market-making mechanisms work you can watch our quick 20-minute explanation on the community Curation Markets call, or dive into the Architecture article on our blog.
- If you’d like to submit a research project you can complete this form on our website or drop us an email.
- If you would like to stay updated & follow the latest project updates, then sign up at the bottom of this form and we’ll let you know as soon as we’ve launched and you can start participating!
*Please note that the information included in this article is not exhaustive, the content has been shortened for the reader for the purpose of communicating the basis of the study. Should you be interested in finding out more about the research team, scientific approach, collection methods or study details — please reach out to us via email & we’d be happy to provide you with more detailed information.
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