Research Program Background
Psychedelic Studies Research Program
What is the Psychedelic Studies Research Program?
Mental illness is a growing global concern. Mounting evidence suggests that psychedelics are effective in cases of treatment-resistant mental health disorders, where innovation is needed most. The regulated use of psychedelic substances for disrupting entrenched patterns of dysfunctional thinking is a promising research avenue. Scientific study of these substances is reemerging after decades of dormancy and setting a modern, future-focused standard for studying these substances is critical.
The purpose of the Psychedelic Studies Research Program (PSRP) is to establish standards for the rigorous study of psychedelics while initiating fruitful collaborations with other research groups and industry partners, and sharing the findings with the wider community. The PSRP has already received fundraising approval from the University of Toronto, and attracted interest from other academics from various institutions in Canada and the US as well as entrepreneurs who would like to develop applications based on our work.
The research produced through the PSRP will create the gold-standard for the emerging field of psychedelic research, build relationships with forward-thinking industry partners, and educate a public that is largely unaware of the science behind psychedelic substances. We will set the benchmark with methodologically rigorous, pre-registered designs and create standards for transparency when working with industry partners to our mutual benefit and the benefit of society at large. Given the re-emergence of enthusiasm for this work and growing novel practices such as microdosing, now is the time to establish standards for research excellence in this growing field.
What is the Current Project About?
The aim of the current project is to conduct a double-blinded, randomized control trial to test the benefits and drawbacks of microdosing Psilocybin. Our priorities are to test the most commonly-espoused benefits and drawbacks of microdosing as described in our previously published work (Anderson et al., Psychopharmacology, 2019), including benefits to mood, focus, and creativity, while also carefully monitoring participant safety and sobriety (including competence to drive) over the trial period.
This study promises to be the first longitudinal clinical trial of microdosing in the world, and an absolutely critical contribution to public understanding and policy about the efficacy and safety of psychedelic microdosing practices.
What Types of Activities will the PSRP Pursue?
The PSRP will engage in four main categories of activity: 1) Psychedelic Research, 2) Academic Dissemination, 3) Community Outreach, and 4) Industry Collaborations.
1) Psychedelic Research
The primary aim of the PSRP is to perform rigorous, innovative, and impactful psychedelic research. The PSRP will uphold the rigorous methodological and transparency standards of Open Science. We will pre-register our analysis plans to demonstrate scientific rigour and share our materials, data, and analysis code to help promote transparency. We will prefer open access publishing when possible.
The PSRP aims to be the first Canadian research facility to investigate psychedelic microdosing, the phenomenon of taking sub-hallucinogenic doses of psychedelic substances. The short-term activities of the PSRP will revolve around this primary research project. In the medium-term, we will flexibly expand our focus to include novel areas of interest revealed by research findings. To this end we have contacted and been contacted by a number of interested academics that will serve on our Board of Advisers, who may provide additional research directions. These may or may not include targeted survey research, clinical trials with psychedelics at various doses, neuroimaging investigations of potential mechanisms, and relevant ethnographic fieldwork. In the long-term, the PSRP stands to become a world-leader known for rigorous psychedelic research and rich collaborative initiatives.
We see cross-sectional research as having been integral for fostering collaborations amidst researchers and clinicians, and guiding the design of our next phase of study: a double-blinded, randomized control trial of microdosing psychedelics, to rigorously test the benefits and drawbacks described in the survey studies.
2) Academic Dissemination
The PSRP has attracted interest from academics at multiple Canadian institutions and from top-tier American universities, creating a growing academic network. The PSRP will utilize this network to share its findings at different universities, as well as various local, national, and international conferences, bringing prestige to the PSRP and to the University of Toronto. We will publish in high-tier journals and seek research grants and funding opportunities based on a foundation of rigorous, transparent research and ongoing collaboration with high-quality personnel.
3) Community Outreach
Despite limited and preliminary findings, recent psychedelic research has precipitated a surge in popularity and an increase in popular press coverage. Online communities dedicated to psychedelic microdosing have grown, including one popular Reddit community growing by an order of magnitude in the past 3 years: from less than 5,000 subscribers in early 2016 to over 50,000 subscribers at present. The public is interested and the PSRP will answer this interest with science.
The PSRP will offer lectures on psychedelic-related topics at appropriate University of Toronto events and may bring in experts from the Board of Advisors, such as Dan Ariely, to offer talks at the University of Toronto. Prior research from the PSRP team was covered on international news outlets (e.g. Vice, Newsweek, CBC, Global News) and opportunities to give interviews and to write media pieces (e.g. op eds, commentaries, explainers) will be welcomed by the PSRP. We will promote PSRP core values and seek to enhance the prestige of the University of Toronto as a world-leader in psychedelic research. The PSRP is committed to clearly communicating our scientific findings with the proper caveats and reservations. We will make every attempt to ensure that press releases are true to our findings and do not exaggerate our results.
4) Industry Collaboration
The PSRP has been in conversation with potential industry partners including YCombinator, MaRS innovation, and Grassfed Ventures. These parties recognize substantial commercialization opportunities for psychedelics and psychedelic-related services with potential Intellectual Property (IP) emerging from the PSRP research programme. Collaborating with these interested parties will provide the university with funds and utilize the knowledge created by the PSRP. The PSRP will abide by the University of Toronto’s guidelines and regulations for IP while generating revenue and new technologies.
Deliverables: What will the PSRP Provide?
- Establishment of an internationally-recognized board of scientific advisors
- Drafting and obtaining cross-institutional recognition for best-practice guidelines for the study of psychedelics
2) Regulatory Approval for Psychedelic Research
- Health Canada approval for psychedelic research at the University of Toronto
- The first approved university protocol for researching psychedelics in Canada
3) Academic Dissemination
- Our team has already published the first pre-registered study of the benefits of microdosing psychedelics
- Regular attendance and presentation at Psychedelics research conferences, including Breaking Convention in London (England), Insight in Berlin (England), and Horizons in New York (USA).
- We will continue to publish pre-registered research, including one more paper this year, an epidemiological report of the population of microdosers.
- We will disseminate best-practice guidelines for the study of psychedelics in at least 4 post-secondary research institutions through our Board of Advisors.
- All of our protocols and data will be made freely accessible for other researchers interested in participating in this research as PSRP partners.
1) Regulatory Approval
The Health Canada application process is complex, but we are now nearing the completion of our initial application as we confirm details of the proposed clinical trial. We expect the process to take a further six months, including revisions, before approval is obtained. Health Canada officials have been forthcoming and helpful throughout the process, and we are confident we can obtain approval within six months.
2) Psilocybin Manufacturing
We expect to obtain psilocybin from a manufacturer as soon as we have Health Canada approval (six months). We have currently identified a reliable (Good Manufacturing Practice “GMP) manufacturer. We have budgeted for a relatively expensive manufacturing process and have been quoted timelines on the order of approximately six months, which fits our timeline for regulatory approval.
A growing list of interested philanthropist, private investors, and potential industry partners are interested in our work. We have already secured a substantial initial donation that will cover the costs of the clinical trial. Working with the Office of Advancement at the University of Toronto, we have also recently received approval from the Provost to expand fund-raising efforts, and are hoping that the PSRP will grow over time, attracting further interest.