Julia Joyes | Research Director at TheraPsil

Julia gained her Masters in Neuroscience from the University of Bristol, UK, where she first was introduced to the benefits of therapeutic psychedelics in treating psychological trauma and other medical indications. Julia has undertaken a variety of research including Alzheimer’s disease, concussion and end-of-life distress and believes that scientists have a responsibility to educate the public on recent advances and discoveries to raise attention towards brain and mental health.

Now based in Victoria, British Columbia, Julia hopes to help expand the current literature surrounding psychedelics and their therapeutic applications in order to make necessary changes to drug policies.

What is the goal or purpose of Project Solace?

The goal of Project Solace is to help patients in medical need across Canada gain access to a safe supply of GMP grade psilocybin products. Psilocybin only became available via the Special Access Program this year and many patients and healthcare professionals are still trying to navigate this legal pathway. TheraPsil has already set the precedent for helping patients gain legal psilocybin access whilst also creating a robust training program. Through Project Solace, TheraPsil will work with manufacturers who have psilocybin products available via the SAP. With Project Solace, TheraPsil aims to make navigating the SAP process easy for patients and their prescribers whilst still ensuring safe and effective treatment. Through working with different psilocybin manufacturers, we hope to build up a psilocybin registry that allows both patients and doctors to choose from a variety of unique medical psilocybin products. At the same time, we will document the patient's experience through real-world data collection. We hope the data collected from this research will be used to help inform much-needed policy changes around psilocybin.

How did the idea for Project Solace come about?

The UK charity - Drug Science have helped us to set up this real-world data registry. In 2018 medical cannabis was legalised in the UK, and by 2019, there were only a handful of medical cannabis prescriptions. Drug Science set up Project Twenty21 to expand patient access and gather data on the various cannabis-based medical products on the market in the UK. Three years later, thousands of patients are submitting Project Twenty21 data every month. We recognize that we are talking about two VERY different drugs and that psilocybin is not yet a legally recognised medicine in Canada. We have amended the Project Twenty21 protocol to apply to medical psilocybin prescriptions and will be working with the Drug Science team and other research groups to analyse the collected data.

How did Drug Science become involved as a collaborator and what will they contribute to this project?

TheraPsil and Drug Science have always supported each other from across the pond, especially as both companies are operating within the non-profit and charity sectors of the psychedelic industries. Having global support always helps to build momentum for what are common goals; public education surrounding the medical benefits of psilocybin, destigmatization, research, and policy change. James Bunn, Head of Operations at Drug Science supported the set up of this project and is continuing to do so with his knowledge and experience of the psychedelic sector.

What other partners will you be working with?

Asides for the different psilocybin manufacturers, we will also be working with a data handler to build out the research design for this project on both a desktop and app version for participants. We will be making changes to our current quantitative observational research and continuing to work with Dr. Robin Carhart-Harris’ team who were originally based out of the Centre for Psychedelic Research at Imperial College, London.
It is our also our aim to work alongside the US non-profit, Unlimited Sciences, to compare datasets to gain further insights into psilocybin use and explore health-related outcomes. Since 2020, in collaboration with Johns Hopkins University’s Center for Psychedelic & Consciousness Research, Unlimited Sciences has conducted observational research of psilocybin users to understand how psilocybin is being used in real-world settings Finally, we want to support MAPS Canada and their plans to conduct research around the SAP process as a way to support prescribing healthcare professionals and help as many patients as possible gain access to psilocybin via the SAP

What methods will you use to obtain the data for this project?

We plan to set up quantitative (questionnaire style) and qualitative (structured interviews) research questions. Participants will be asked to complete this research before their psilocybin experience and after for up to 2 years so that we may follow and document each patient's experience.

How will this data help facilitate SAP access to psilocybin for current and future patients?

Due to psilocybin being a restricted substance for so long, mainly due to the War on Drugs in the 1960s, it is now more important than ever to document patient experiences of gaining legal access to psilocybin in today’s climate. Our hope is that this data can then be used to inform necessary changes to drug policy and hopefully lead to psilocybin becoming fully medically available for anyone who is in medical need.

Why is it important to track the use of prescribed psychedelic medicine in clinical practice and build a database of trained healthcare professionals?

Safety and efficacy are at the forefront of our goals. By documenting the prescribed use of psilocybin via the SAP, we are able to start building up a registry of different psilocybin products and their impact on patients’ health. Psilocybin however is not like any prescription pharmacy drug. It is a drug therapy combination and requires prescribing healthcare professionals to be competent in understanding the safety and limitations before recommending it to their patients. It also requires a therapy team to be trained in guiding a patient through their psychedelic experience within a safe containing in order to promote lasting healing.

Given that much of the data will be anonymized, how will you validate the accuracy of the data that you provide to government regulatory agencies?

The research side of the project will have to be approved by ethics. Anonymizing data ensure that there is no bias of results and protects patient’s identity. With that said, we have been in close communication with Health Canda throughout the roll-out of the SAP and will continue to do so to ensure that the data we collect is an accurate depiction of the healing effects of medical psilocybin. We will be able to group data by psilocybin product, but essentially all data will go through a rigorous statistical analysis. The more participants we enrol into the research, the more robust the data will be and the higher the confidence.

Why can’t patients simply wait for clinical trial openings or other legal pathways to accessing psilocybin-assisted psychotherapy?

While clinical trials are helping much to push the regulatory envelope open, unfortunately for many patients, they are not a viable option due to specific inclusion and exclusion criteria, location and for many patients who are palliative, the time they have left. We believe that all patients in medical need who meet the safety requirements should have the right to psilocybin-assisted psychotherapy and in an environment that they choose and feel comfortable in.

Will Project Solace offer any potential long-term benefits in regards to federal approvals or regulations?

Will the data be used to help advance federal and international access to psilocybin for compassionate care? The Speical Access Program (SAP) has only opened up to allow psilocybin to be accessed via this pathway this year. The more data we can gather around the safety and efficacy of psilocybin, the greater the argument we can create to push government to make regulations for medical psilocybin. The longer this study runs and the more participants we are able to enroll creates an even stronger argument.

Who is doing important work in the world of psychedelics that you think more people should be aware of?

There are many individuals and companies around the world doing some truly great work both in terms of advancing research and also education surrounding psychedelics. In name a few institutions leading the way of psychedelic research:

• John Hopkins Center for Psychedelic and Conscious Research – Baltimore, Maryland
• Heffter Research Institute – Santa Fe, New Mexico
• Center for Psychedelic Therapies and Research – San Francisco, California
• Imperial College London Centre for Psychedelic Research – London, UK
• MAPS - Canada and USA
• Hakomi Institute - Boulder, Colorado
• Center for the Science of Psychedelics - Berkeley, California
• Pacific Brain Health Center - Santa Monica, California

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There are also a lot of incredible advocates, authors and spokespeople. I personally love the Drug Science Podcast as a platform - Prof. David Nutt is joined by world-renowned experts to discuss research, harm reduction, drug policy, and the science behind drugs

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