Part II of an interview with Dr. Ryan Vandrey and Dr. Johannes Thrul from Johns Hopkins University
The study’s co-directors share insights into this landmark study, explain its significance, and how DRUID is participating. With over 10,000 study participants, the project is the largest of its kind and seeks to provide a foundation to address the extensive gap in knowledge about the variety of cannabis products and their effect on medical and non-medical cannabis users.
PART II
Q. Can you summarize how the longitudinal study you are starting came about and the study’s goals?
Vandrey: Cannabis has been legalized and is being recommended as an alternative treatment for a number of health conditions. However, we don’t have the usual evidence from proper drug development to support this use in many situations. The other reality is that we don't know what the term “cannabis” means anymore. There's a multitude of different types of cannabis products, and they vary in chemical composition, formulation, and intended route of administration. All of those variations alter the abuse potential, alter the therapeutic efficacy, and alter the safety of the product. In addition, research continues to show that there are important differences in response to cannabis products across subgroups of people, such as men versus women and older versus younger adults.
We're trying to catch up with the market and understand the health effects of medicinal cannabis use to help better interpret the public health impact of legalization and to help steer medical decision making amongst people who are interested in using cannabis for therapeutic purposes.
Right now, neither clinicians or patients have a lot of concrete data to work from to determine which type of cannabis product would be most beneficial for any particular health condition, and for any of the hundreds of health conditions that people are considering cannabis use for, they don't know the dose or the frequency of dosing that's optimal. Whereas for most other prescription medications, there's been a decade or longer clinical research program that answers and fixes all of that, and you have a very guided and fixed approach to how you conceptualize and implement therapeutic use of those drugs.
Q. For example, what specific questions are you trying to answer?
Vandrey: We're using this longitudinal observational study to understand a number of questions: What proportion of people trying medicinal cannabis gain any benefit from it for particular health conditions? What are the most common adverse effects and are there product types, doses or routes of administration that are better/worse? What types of products do the patients find most beneficial? What dose regimen do they use? And then we can try to take that big, broad approach to understanding the health effects and health consequences here, and identify the most promising areas and design clinical trials to properly evaluate the medicinal effects of specific and targeted cannabis products?
Our hope is that this research can identify particular health conditions for which there seems to be a lot of promise, and then where there is promise, we try to reverse engineer the data that we collected here to conduct more targeted clinical trials with a more focused and targeted therapeutic product in terms of chemical composition, formulation, and route of administration and dose. Then we can do the more traditional drug development approach.
Q. With this broad swath of data, will this study spawn a lot of other studies?
Thrul: Yes, precisely. We see it as a platform that other studies could be built onto. Initially, we're starting with one big cohort, a longitudinal data collection with 10,000 patients. We're getting them in the door when they just get their medical cannabis recommendation. We're looking for folks who, for the first time, are using medicinal cannabis and want to treat a specific health condition. We're agnostic to what condition that is. We're following them for a year with an online survey platform: at baseline, one month, three month and 12 month follow up. Then we have several sub-studies, which includes a sub-study with smartphone-based assessments, so people will conduct self-reports on a survey app day to day, how they're feeling, whether or not they've used cannabis, but also detailed assessments pre and post cannabis administration. We're asking them to fill out a survey before they use a product, and then, depending on the route of administration, we'll send them a follow up to get at the acute effects of what that product did for them.
That's where the DRUID app comes in. Self-reported questionnaires only get you so far. What the DRUID does is to give us objective data on the level of performance from pre to post cannabis administration.
Then we have a large sub-project that will work with electronic medical records to identify medicinal cannabis patients so we can identify and use the large data sets that the electronic medical records produce to compare patients to matched non-patients. For example, look at the health outcomes over time. And there's really a wealth of data out there in electronic medical records, but cannabis is not well tracked at all.
Q. How many people are working on this expansive project and when will you have preliminary findings?
Vandrey: We have about 25 people right now, including, the boots on the ground folks here who are helping us conceptualize the data collection, computer scientists, the Realm of Caring Foundation, and our advisory board of global experts with diverse areas of expertise.
Q. Is this the largest project you've ever undertaken in terms of the number of patients or cohorts and people working on it?
Vandrey: Absolutely, Yes. I've been part of some big research projects, but this is the biggest thing that I've been the lead on, for sure. But, we're not trying to do this alone. We're pulling in all kinds of folks that have amazing expertise in all of the complementary facets of this project. I think of Johannes and I as architects of a mission more so than as the ones actually executing the project. There are many stakeholders and many people who are and will be involved.
With respect to the DRUID, in our laboratory studies, we take healthy adults and we give them a sledgehammer dose of THC, and we say, look, they're impaired. That doesn't always translate to the medical use scenario. There's a lot of nuance there that's really important for the patients, the clinicians, the legislators, and law enforcement to understand. For example, in some cases, patients are substituting cannabis for other medications that may be more impairing to daily functioning. In other cases, cannabis may cause some acute impairment, but may also improve sleep or pain to the extent that the net result is improved performance. In a third scenario, otherwise healthy and well-functioning patients may use cannabis and end up significantly impaired and unable to perform basic daily activities safely, such as driving a vehicle. It is very important that we capture data from large cohorts of medicinal cannabis patients to understand the impact that medicinal cannabis use has on daily functioning so that both patients and providers can make informed decisions about whether or not to try cannabis as a therapeutic, and, if so, what type of product is most appropriate and maximizes clinical benefit, while minimizing potential harms.
Q. Will there be any results that can be shared within the five year span of the study?
Thrul: Yes. Once we have reasonable sample sizes to report, we will certainly do that. The data that we're collecting will go into a repository for external investigators to apply to use our data and evaluate and analyze them. We will produce way more data than any of us or any of our team could ever investigate all outcomes of interest. And there are plenty of smart people out there with amazing ideas of how to utilize the data we will collect. We will also take data from other collaborators, other international investigators that want to donate some of their data, and integrate their data with ours into a single, large, and integrated data repository. Again, the intent here is that this project will serve as a platform for a larger community effort helping to drive scientific advancement.
Q. How are you going to recruit so many participants and how are you publicizing the study?
Vandrey: We're going to use a multi-pronged approach for enrolling patients, because we want a very representative patient population. We're going to be advertising through social media, through foundations, and traditional media as well. After we go full gusto on our project, we'll be working on press releases to make the science community and general public more aware. 10,000 patients is our starting point. That’s what we have current funding for. Our hope is that we can continue this program in perpetuity and for other people to apply for grants and utilize our platform to increase that sample size.
About the Directors and the Study
Ryan Vandrey, PhD
Professor of Psychiatry and Behavioral Sciences
Johns Hopkins University Behavioral Pharmacology Research Unit (BPRU)
Director of the Cannabis Science Lab (CSL)
Johannes Thrul, PhD
Associate Professor of Mental Health
Johns Hopkins Bloomberg School of Public Health
NIH RePORTER: Project Number: 1UM1DA059000-01
Due to changes in cannabis policy, most Americans now have access to an array of retail cannabis products. An estimated 5.5 million Americans are registered with state-regulated medical cannabis programs and the therapeutic use of federally legal hemp (e.g. CBD) products is widespread. Despite most states having legalized medicinal cannabis use, little is known about the characteristics of these patients, the cannabis products they use, or the patient-level health impact of their medicinal cannabis use. Filling these gaps in knowledge remains an urgent public health need.
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