The federal prohibition of cannabis continues to make researching the plant difficult, especially when researchers want to work with THC-rich cannabis flower or any other industry-standard products. The issue has led to some new avenues for studying the plant, like in Colorado where the nonprofit Realm of Caring currently researches novel healthcare options including cannabis and hemp.
Ganjapreneur recently connected with Matthew X. Lowe, the Research Director for Realm of Caring and for Unlimited Sciences — which is a psychedelics research firm — to discuss cannabis and psychedelics medicinal research. This interview covers why this research is necessary, who benefits from it, the methods used to understand the healing possibilities of these compounds, and more!
Scroll down for the full interview.
Ganjapreneur: Why are you interested in cannabis and psychedelics research?
Matthew X. Lowe: While cannabis and psychedelics have been utilized by humans for millennia, we still have much to learn about them. In the U.S. alone, approximately half of American adults have tried cannabis at least once in their lives, and researchers in 2013 estimated that over 30 million people have tried psychedelics in their lifetime. Despite a growing body of research recognizing the therapeutic potential of these substances, the desire to use cannabis and psychedelics has often been treated as a pathology and deeply stigmatized. Restrictive drug scheduling of these substances under the Controlled Substances Act (CSA), which came into effect in 1971, significantly impeded scientific exploration and understanding, leaving us poorly equipped to manage the rapidly growing popularity of cannabis and psychedelics in our current climate. Further research is critically needed to understand the treatment effectiveness of these substances and how we can mitigate potential harm. Cannabis and psychedelics have had a profound impact in shaping the lives of millions of individuals, myself included—and through increased research, education and awareness, I believe these substances could positively impact countless more lives.
How does Realm of Caring assist medical patients?
Realm of Caring (RoC) is a 501(c)(3) nonprofit organization facilitating the mainstream acceptance of cannabinoid-based therapies and building an empowered community through research and education. RoC is committed to researching novel healthcare options to improve quality of life. We have served tens of thousands of families and healthcare professionals since 2013. In addition to our research directives, RoC operates a free call center that uses published research, including our own published data, to provide guidance to those who need it. Since 2015, we have logged almost 3 million minutes working one-on-one with individuals and medical professionals, sharing resources for finding quality products, administration best practices, potential interactions and how to measure success.
What is the Observational Research Registry (ORR)?
RoC’s Observational Research Registry (ORR), conducted in partnership with Johns Hopkins University School of Medicine, is one of the largest cannabinoid studies in the world in terms of enrolled individuals. The ORR is an Institutional Review Board (IRB) approved, online survey study examining the real-world applications of cannabinoid products and participation is open to anyone in the world with internet access whether you use cannabis or not.
Can a brand benefit by having its product in the ORR? Are there specifications for what products go into the ORR?
Yes, a cannabis or hemp company can absolutely benefit from having its products in the ORR. ORR data represents an alternative solution to profile the medicinal use of cannabinoid products on individuals’ health conditions in their natural environment. Repeated assessments provide a rich opportunity to examine the impact of cannabinoid therapy over time among individuals with a diverse list of health conditions. ORR data also provides the opportunity to examine product dosing over time and between products. For a company this means they will receive: 1) A snapshot of product use in the natural environment of the consumer; whether domestically or internationally; 2) Thoughtful and meaningful demographic data on who is using their products and individuals’ anonymous self-reported therapeutic responses; and 3) Research and data that informs how the company develops and markets its products. For more information on products used in the ORR, please contact Realm of Caring.
What methods do you employ to gather reliable research data from medical cannabis patients?
To ensure our observational research gathers reliable data, we employ a study design that includes a mix of standardized measures that can be easily quantified, therefore ensuring that our methodology can be replicated by other researchers, and open-ended questions that allow for qualitative, firsthand accounts of experiences, which otherwise couldn’t be captured by standardized measures alone. Our research is IRB-approved and conducted in collaboration with world-renowned experts at Johns Hopkins University School of Medicine, and our research is published in peer-reviewed journals that critically assess the validity and reliability of research data prior to publication.
What is the mission at Unlimited Sciences? How does your role at the brand support that mission?
We’re facing a paradigm shift with psychedelics, similar to what we’ve seen with medical cannabis in recent decades—and research is ramping up to reveal the full therapeutic value. Unlimited Sciences is a psychedelic research nonprofit started in 2018 as a fiscal sponsee of the Realm of Caring Foundation that combines the power of data and lived experiences to serve the community, educate the public and inform commonsense practices and policies surrounding psychedelics. As the Director of Research, my objective is to achieve a standard of research that will have a significant positive contribution to our understanding of psychedelics as an efficacious therapeutic tool. By conducting careful and thoughtful observational research, we can realize both the extraordinary benefits and the potential risks of psychedelics.
Why did Unlimited Sciences begin by studying Psilocybin? Will the scope of research eventually expand to other psychedelic medicines?
In recent years, psilocybin has seen an easing of restrictions and a marked increase in popularity. Active legislative efforts for the decriminalization of psilocybin exist in several states across the U.S. Additionally, an estimated 1 in 10 individuals in the U.S. have used psilocybin at some point in their lives, representing an enormous potential of untapped data that could have profound implications in our understanding of psychedelics. Since 2020, in collaboration with Johns Hopkins University’s Center for Psychedelic & Consciousness Research, the Unlimited Sciences observational psilocybin registry has enrolled over 7,000 individuals. Building and expanding on the success of our psilocybin registry, Unlimited Sciences is currently developing a general registry to learn more about the positive and/or negative outcomes of using psychoactive medicines in naturalistic settings and any potential factors that could affect those outcomes. By collecting data from individuals who are already utilizing or planning to use psychedelics, we aim to tap into an existing database of people who can share their experiences and help change the face of psychedelic medicine.
Why are survey studies valuable for psychedelics? How are mitigating factors taken into account in this study?
Clinical trials are crucial to understanding the acute effects of psychedelics. However, most individuals currently using psychedelics are not doing so within the controlled environment of a laboratory. Survey studies capture critical data from real-world psychedelic experiences where set and setting can vary substantially from one individual to the next (“set” is an individual’s mindset and “setting” refers to their physical and social environment). Well-conducted observational research studies can result in a breadth of information collected about a particular behavior and these studies are essential for understanding the full spectrum of the psychedelic experience. Furthermore, observational research can play a significant role in the reversal of stigmas caused by the prohibition of psychedelics. Although observational research is an invaluable tool to understand the human experience, such studies are limited by their susceptibility to bias due to a reliance on self-report data, which is something a placebo-controlled clinical trial mitigates. However, observational data can provide strong foundations and pave the way for clinical trials research.
What are the challenges with researching psychedelic medicines? Are they similar to the challenges cannabis researchers face?
There are several challenges faced by both cannabis and psychedelics researchers, largely due to decades of federal prohibition and the current restrictive drug schedules. Despite the recent proliferation of private investment in psychedelic and cannabinoid-based drug development, there are still many barriers to federally supported research. Compared to the recent rapid increase in popularity and usage of these substances, there is still a lack of research on the safety, legal, social and ethical implications of cannabis and psychedelic medicines. Although weighed down and restricted by political discourse, cannabis and psychedelic therapy should be treated as a health issue, not a political issue and it is essential that research is not only allowed but encouraged through federal support.
What areas of research are you most excited to explore in the coming year?
There is a need for innovation beyond our current approaches to mental and physical healthcare and the therapeutic value of these substances is boundless. I am most excited to see this movement continue to gain traction and enter mainstream acceptance, with a focus on individualized medicine and how we can alleviate suffering in innumerable conditions of the body and mind. In the coming year, Unlimited Sciences will focus our efforts on the development of our upcoming general registry and seek to forge a new path in our approach to healthcare.
Will you elaborate on what you mean by individualized medicine and why this is vital when prescribing cannabis and/or psychedelic treatments?
A ‘one size fits all’ approach to healthcare can often be detrimental to the needs of the individual. Individualized medicine—also known as personalized or precision medicine—tailors medical products and treatment approaches to the individual based on their unique medical, genetic, environmental, and personal history. For example, the needs of a 70-something mostly sedentary female patient with chronic pain differ from a 40-something active male with chronic pain. With an individualized approach to medical cannabis, treatment can be optimized to suit the goals of the individual, including dosage, dosing schedule and route of administration, and cannabinoid and non-cannabinoid content. Our observational research focuses on understanding the contributing factors that lead to treatment success or failure at the individual level by examining a broad array of environmental, medical, and personal metrics. By collecting data from individuals we can learn how best to optimize treatment strategies.
There are various testimonies of abuse in psychedelic therapy settings that span back decades. How can a patient be confident in their safety when engaging with an intentionally healing psychedelic experience? Can you share any ‘red flags’ to help others avoid harm?
The relationship between a therapist or facilitator and the patient is a key component of successful treatment. As the psychedelic community rapidly grows, many U.S. states are attempting to create regulated models for psychedelic services, including setting standards to which the training and in-the-field work of psychedelic facilitators must be held. Before engaging in psychedelic therapy, ensure sufficient mechanisms have been put in place for safety practices and ethical standards to protect individuals from harm and provide optimal support should an experience be negative. Look for strong and transparent standards around training, transparent and regular evaluation of facilitators, channels for accountability and compassionate care, and systems to recognize and investigate formal complaints. Psychedelic facilitators should be held to the same high standards as traditional therapists, and it’s just as critical to finding a facilitator whom you feel comfortable and secure with. Before engaging in psychedelic therapy, take the time to familiarize yourself with your facilitator, including the discussion of treatment approaches and setting boundaries, and to look for any red flags that could compromise the integrity of a psychedelic facilitator or guide, including lack of experience, inflated ego, violations of confidentiality, ineffective communication, defensiveness when given feedback, and lack of boundaries. Finally, since integration (the process of integrating the insights of a psychedelic experience into daily life) is a critical component of successful psychedelic therapy and harm reduction, discuss integration practices and approaches with your facilitator, including support should your experience lead to negative or difficult emotions.