Session I
Session I:
Advancing the Science of Medical Cannabis: Research from Real‑World Data to Clinical Trials
Panelists:
Dr. Catalina Lopez‑Quintero, MD (IMG), Ph.D., Assistant Professor, Department of Epidemiology, College of Public Health & Health Professions, and College of Medicine, University of Florida
Dr. Juan Pérez‑Carreno, MD (IMG), MS, MBE, Ph.D. – PhD candidate, Department of Epidemiology, College of Public Health & Health Professions, and College of Medicine, University of Florida
Dr. Md Mahmudul Hasan, Ph.D., Assistant Professor, Department of Pharmaceutical Outcomes and Policy, University of Florida
Dr. Karina Villalba, Ph.D., Assistant Professor, Department of Population Health Sciences, College of Medicine, University of Central Florida
Abstract:
This session will outline the main activities of the Consortium for Medical Marijuana Clinical Outcomes Research. We will first present the aims and methodology of the Medical Marijuana and Me (M3) study, which was launched to fill gaps in knowledge about the safety, efficacy, dosage, delivery routes, indications, and drug interactions of medical marijuana (MMJ). The study enrolled roughly 1,200 Florida medical‑cannabis patients; 600 completed baseline, 3‑month, and 9‑month follow‑ups, and a separate cross‑sectional arm included 632 current MMJ users. The design provides a large, state‑level dataset that permits examination of real‑world outcomes for the most common therapeutic indications. The first talk will quantify real‑world THC exposure across diverse cannabis products. Detailed self‑reported data on frequency of use, route of administration, and product potency will be used to estimate daily THC intake (mg THC/day), adjusted for route‑specific bioavailability. We will identify distinct profiles of cannabis use based on multidimensional behavioral patterns, evaluate demographic and health correlates of these profiles, and assess whether commonly used frequency categories adequately capture variation in cumulative THC exposure. The second talk will describe results for the three main conditions of use: chronic pain, anxiety, and sleep. For pain, we will summarize product preferences, dosage ranges, and symptom‑reduction trajectories observed over nine months. We will then pivot to sleep, detailing changes in self‑reported sleep quality and their correlation with specific cannabinoids and THC dosage. Finally, the presentation will cover longitudinal anxiety data, including changes in GAD‑7 scores and the influence of individual characteristics such as age, sex, cannabinoid type, and THC dosage. The third talk will introduce attendees to the consortium’s MEMORY database, a rich repository developed in partnership with the Florida Department of Health. Drawing on the Medical Marijuana Use Registry (MMUR), which captures certifications, product types, routes of administration, adverse events, and patient demographics, MEMORY is uniquely positioned for comprehensive studies. We will outline how linking MMUR data with Medicaid, Medicare, and state vital records enhances longitudinal outcome assessment. Illustrative findings from recent safety and effectiveness studies will be briefly presented. The final talk will describe the grants program and discuss the protocol for a recently funded study, as well as the resources available to investigators at the consortium for conducting clinical trials, including regulatory support. The WAVE Study is a pilot, randomized, double‑blind, placebo‑controlled trial testing water‑soluble cannabidiol (CBD) as an early pharmacologic intervention for risky drinkers who do not yet meet criteria for Alcohol Use Disorder (AUD). Forty‑five adults meeting NIAAA criteria for hazardous alcohol use will be enrolled and randomized to full‑spectrum CBD, broad‑spectrum CBD, or placebo for eight weeks (75 mg/day escalating to 150 mg/day), with a one‑month follow‑up. Primary outcomes are feasibility (recruitment, retention, adherence, acceptability) and safety of daily water‑soluble CBD. Secondary outcomes include preliminary effects on drinking days, heavy drinking days, and alcohol craving. Findings will inform larger trials and scalable early‑intervention strategies for risky drinking. By offering a comprehensive view of the research activities conducted at the consortium, we will provide a brief overview of how conference participants can obtain access to the data via a data‑use agreement, collaborate in strengthening the Medical Marijuana (MMJ) Contact Registry, or connect through the Connect and Advance Research for Medical Marijuana Analysis (CARMMA) database, thereby advancing cannabis science in Florida and nationally through alliances with other cannabis‑research partners.
Dr. Catalina Lopez‑Quintero, MD (IMG), Ph.D.
Dr. Catalina Lopez‑Quintero, MD (IMG), Ph.D., Assistant Professor, Department of Epidemiology, College of Public Health & Health Professions, and College of Medicine, University of Florida
Bio:
Dr. Catalina Lopez‑Quintero, Assistant Professor in the Department of Epidemiology at the University of Florida, leads a research program that bridges epidemiologic investigations and randomized clinical trials to advance evidence on cannabis and medical cannabis. Her scholarly focus lies at the intersection of drug use, neuropsychology, and socio‑cultural determinants, with particular attention to populations that are often under‑represented in cannabis research, including racial‑ethnic minorities, older adults, pregnant women, and individuals with psychiatric disorders. Her clinical research evaluates the safety and efficacy of cannabidiol for moderate‑to‑severe anxiety and sleep disturbances. In epidemiologic studies, Dr. Lopez‑Quintero has mapped patterns of use, motives, and correlates across these groups, elucidating how medical versus recreational use informs health outcomes such as pain, mood, and driving‑under‑the‑influence risks. These dual‑track investigations inform clinical guidance and policy, clarifying both the benefits and risks of cannabis therapies. Her work also informs regulatory frameworks and underscores the need for personalized dosing guidelines, ensuring safer and more effective therapeutic use of cannabis. Through rigorous data collection, robust analytic methods, and stakeholder engagement, including interviews with prescribers, Dr. Lopez‑Quintero builds a reliable evidence base that supports optimization clinical medical cannabis interventions and public health strategies.
Dr. Juan Pérez‑Carreno, MD (IMG), MS, MBE, Ph.D.
Dr. Juan Pérez‑Carreno, MD (IMG), MS, MBE, Ph.D. – PhD candidate, Department of Epidemiology, College of Public Health & Health Professions, and College of Medicine, University of Florida
Bio:
Juan Guillermo Pérez, is a physician and PhD candidate in Epidemiology at the University of Florida. His research integrates epidemiologic methods and real-world data to better understand how cannabis use patterns influence cardiovascular outcomes. Dr. Pérez has over a decade of experience in clinical research and evidence synthesis, including work in clinical practice guidelines development and multicenter clinical trials.
Dr. Md Mahmudul Hasan, Ph.D.
Dr. Md Mahmudul Hasan, PhD., Assistant Professor, Department of Pharmaceutical Outcomes and Policy, University of Florida
Bio:
Dr. Hasan is an assistant professor in the Department of Pharmaceutical Outcomes and Policy with a joint appointment in the department of Information Systems and Operations Management at the University of Florida. He is also the Assistant Director and Faculty Lead of the Medical Marijuana Research Repository for the Florida state-funded Consortium for Medical Marijuana Clinical Outcomes Research. Dr. Hasan’s research lies in the intersection of pharmaceutical outcomes and health service utilization with a focus on substance use and mental health disorder, opioid related adverse health outcomes, and chronic diseases. From a methodological standpoint, Dr. Hasan utilizes data science, in particular, cutting-edge AI/machine learning, statistical modeling, and management science techniques. His substance use research using AI has received significant media attention including National Public Radio’s (NPR) AI Minute, The Main Street Daily News Gainesville, FL, Medical Press, Mirage, Futurity, and several news portals within the University of Florida.
Dr. Karina Villalba, Ph.D.
Dr. Karina Villalba, Ph.D., Assistant Professor, Department of Population Health Sciences, College of Medicine, University of Central Florida
Bio:
Dr. Karina Villalba is a tenure-track Assistant Professor in the Department of Population Health Sciences at the University of Central Florida College of Medicine, with a joint appointment in the Violence Against Women Faculty Cluster. She holds a Ph.D. in Public Health, and her research integrates clinical intervention and epidemiology to examine the therapeutic potential of cannabinoids in the treatment of mental health and substance use disorders. Dr. Villalba currently leads several investigations, including the WAVE study a randomized controlled trial evaluating water-soluble CBD for alcohol reduction, and the BEYOND study, an 18‑month longitudinal study focusing on simultaneous alcohol and cannabis use among Bolivian young adults. She is also leading a national study on perceptions of CBD- and THC-infused beverages among Millennials and Gen Z in the context of recent federal regulatory changes. Her work further addresses the intersections of HIV, violence, and adverse childhood experiences supported by a collaborative research network across Latin America and Spain.