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Realm of Caring is a 501c3 nonprofit organization that conducts their own research such as their endeavor of the Observational Research Registry (ORR) study. They are also involved in advocacy work to help battle the stigma surrounding cannabis. In this interview, Nicolas Schlienz, PhD, Research Director at Realm of Caring, discusses the organization’s efforts to educate the public and healthcare professionals on the research being done on medical cannabis.
Can you tell us a little bit about yourself? How did you become interested in the cannabis industry?
Nicolas Schlienz: I’m a clinical research scientist and earned my PhD in clinical psychology from the State University of New York at Buffalo. My early career interests focused on the study of nicotine and tobacco with an emphasis on pharmacological treatments for smoking cessation. As a degree requirement, I completed an internship at a Veterans Affairs facility in Bedford, Massachusetts. As an intern specializing in drug addiction, I would overhear veterans talking about the use of medical cannabis as an alternative treatment for symptoms of post-traumatic stress disorder (PTSD) and as a potential approach to reduce daily use of numerous prescription medications, and that piqued my curiosity.
I was lucky to have the privilege of completing a research postdoctoral fellowship at Johns Hopkins University School of Medicine (JHU) under the mentorship of Dr. Ryan Vandrey, an internationally-recognized scientist in the field of cannabinoid research. There, I worked on several cannabis studies, which cemented my career path choice.
What is the Realm of Caring (RoC)?
Schlienz: Realm of Caring is a 501c3 nonprofit organization with three central goals: research, education, and advocacy. Through research, we gain valuable insights on the real-world use of and health effects of medicinal cannabis and hemp through our Observational Research Registry (ORR). Realm of Caring seeks to educate consumers and healthcare professionals on existing research investigating medicinal cannabis and cannabinoid therapies. RoC’s Care Specialists assist clients worldwide in choosing quality products and provide compassionate one-on-one support to individuals utilizing cannabinoid therapies.
How did you become involved with RoC?
Schlienz: I became involved with Realm of Caring while completing a research postdoctoral fellowship at JHU under the mentorship of Dr. Vandrey. I helped develop, program, and launch the ORR survey study during my training at JHU.
What do you expect your role as the RoC’s first-ever Research Director to entail (what are your goals)?
Schlienz: My immediate goals are to increase enrollment in the ORR survey study to improve our understanding of the wide range of medicinal cannabinoids used by individuals with myriad health conditions and symptoms. I will also oversee our ORR survey data and work with our colleagues to publish our findings in peer-reviewed journals. Additionally, I will be regularly updating the Realm of Caring staff on the latest advances in cannabis science to inform interactions with patients, healthcare providers, and the community.
Does RoC offer educational/medical resources for patients and others seeking to learn more about medical cannabis?
Schlienz: Yes! We offer direct support to clients requesting more information about cannabinoid therapy. Resources include: 1) adult, pediatric, and pet dosing guidelines informed by client data and published research; 2) product recommendations; 3) monthly webinars covering a range of topics; and 4) informational blogs updated weekly. Our care team offers free one-on-one ongoing support to clients. Our goal is to provide clients with up-to-date information on cannabinoid therapies and to educate on how to navigate the rapidly growing list of cannabinoid products.
What is the Observational Research Registry (ORR)?
Schlienz: The Observational Research Registry (ORR) is an online survey study of cannabinoid therapy that examines the health outcomes over time among individuals enrolled in the registry. Following standard research practices, this study has been reviewed and approved by the JHU Institutional Review Board. We strive to make the ORR inclusive; individuals interested in participating are not required to be current medicinal cannabis users nor are they required to have a health condition or a formal medical diagnosis. Participants receive a unique link to the web survey that contains questions that ask about cannabis or hemp product use, prescription and over-the-counter medications, and general health questions that ask about anxiety, depression, chronic pain, sleep, quality of life, and use of health care services. Cannabis legislation reform and emergence of new products opens doors for pursuing future research with widespread implications.
Can you tell us about some of your findings from the epilepsy and cannabidiol (CBD) study you recently published in Epilepsy & Behavior (1)? How did the study come about?
Schlienz: We looked at the use of artisanal CBD, which are non-pharmaceutical products. Compared with Controls (non-users), Artisanal CBD users reported greater health satisfaction, and quality of life ratings that were qualitatively higher (but fell short of reaching statistical significance). Artisanal CBD users also reported lower anxiety and depression compared with Controls, and adult CBD users reported improved sleep whereas child users demonstrated a marginally significant improvement on sleep ratings. Artisanal CBD users also had lower odds of past-month emergency department visits and past-month sick days from school or work. Interestingly, a subset of Controls that denied use of artisanal CBD at baseline-initiated use of artisanal CBD during follow-up surveys; CBD initiators reported improvements in quality of life, physical health and psychological health, and reductions in anxiety and depression. We failed to observe differences between Artisanal CBD users and Controls for past-month generalized or other seizure types. However, our inability to find a difference between Artisanal CBD users and Controls may be attributed to multiple factors. Nearly half of participants (49%) reported no past-month generalized seizures and 40% reported no past-month non-generalized seizure types, which may have resulted in a “floor effect.” Participants also reported a median CBD dose of 1.4 mg/kg/day, which is below the recommended pharmaceutical CBD dose of 10 mg/kg/day.
That study brought together researchers from a variety of locations—RoC, Johns Hopkins University School of Medicine, University of Buffalo, Medical University of South Carolina, and Canopy Growth (1). What role did each of you play in the study?
Schlienz: Heather Jackson, the founder of Realm of Caring, played an instrumental role in conceptualizing this observational patient research study. After multiple conversations with Dr. Ryan Vandrey at Johns Hopkins University School of Medicine and Dr. Marcel Bonn-Miller at Canopy Growth Corporation, the details of the study were finalized, and the web survey was programmed. Following its launch in 2016, we actively monitored study progress and the staff at Realm of Caring assisted with recruitment efforts. After accruing data for several years, Dr. Justin C. Strickland took the lead on writing up the study and all co-authors reviewed drafts of the manuscript and provided critical feedback to publish a high-quality study.
What conclusions did your study unveil? Were you surprised by any of the results?
Schlienz: Users of artisanal CBD products reported greater health satisfaction, lower anxiety and depression, sleep improvements among adult users, lower odds of past-month emergency department visits, and past-month sick days from school or work. The majority of artisanal CBD users denied the presence of any adverse effects. Longitudinally, Controls that initiated use at follow-up assessments exhibited significant quality of life improvements and significant reductions in both anxiety and depression. No significant group differences emerged for past-month generalized and past-month non-generalized seizure types. This finding was particularly surprising, but review of the data suggests that the combination of a floor effect relative to the percentage of past-month generalized (49%) and non-generalized (41%) seizures may have contributed to this outcome. Looking at individual dosing for artisanal CBD products also revealed a median CBD dose of 1.4 mg/kg/day, which is well short of the recommended dosing for pharmaceutical CBD (10 mg/kg/day).
What are your plans moving forward from the research obtained in your study?
Schlienz: The process of developing and collecting data for our Observational Research Registry (ORR) study highlighted a number of areas for future research. Compared to clinical trial settings, observational studies face a number of challenges due to the absence of a controlled environment. Precise measurement of dosing amount, dosing frequency, and accurate chemotype classification can be influenced by a variety of factors that are beyond the control of the investigators. Identifying, developing, and evaluating novel methodological approaches to help ensure proper reporting is one topic of particular interest to us. Integrating artisanal CBD into a treatment regimen may also be a challenging process; provider knowledge and patient-provider interactions may be most productive when both provider, and patients have open dialogues when considering use of medicinal cannabinoids.
Is there anything further you would like to add?
Schlienz: Visit https://realmofcaring.org/observational-research-registry/ to participate in our Observational Research Study and to stay up-to-date with our latest research publications, including a study that examined the health effects of medicinal cannabis on anxiety and depression. Register as a client at https://realmofcaring.org/resources/client-portal/ to access our education series and view additional cannabinoid therapy resources.