Ruba Sajdeya
University of Florida
Co-authors: Yan Wang1, Hannah Fechtel1, Gabe Spandau1, Sebastian Jugl1, Nicole E Smolinski1, Amie Goodin1, Joshua Brown 1 Almut G. Winterstein1, Robert L. Cook1
1University of Florida
Background: Significant knowledge gaps regarding the effectiveness and safety profile of medical marijuana (MMJ) impose challenges for MMJcertifying clinicians who make treatment recommendations. The Medical Marijuana & Me (M3) study is proposed to collect patient-centered data from Florida MMJ users.
Objectives:
- Quantify MMJ use persistence and identify reasons for discontinuation.
- Describe outcome trajectories for primary reasons for MMJ use and determine factors associated with different trajectories among MMJ initiators.
- Describe MMJ use patterns, including consumption modes, dosing, and use frequency that patients report as “most effective,” and identify characteristics associated with such use patterns.
- Describe changes in products, consumption modes, and dosing over time. 42 – CCORC 2022
- Characterize adverse effects, including cannabis use disorder, and identify associated products and patient characteristics.
- Track alcohol, tobacco, and other substance use among MMJ initiators.
- Describe concurrent prescription medications use, and factors associated with changes in medications after initiating MMJ.
- Identify concomitant medication use with potential drug-MMJ interactions risk
Protocol Summary: The M3 databank will house: 1) data from a prospective cohort of MMJ initiators who complete surveys at enrollment, three months, and nine months after MMJ initiation, and 2) data from a cross-sectional sample of current MMJ users. A multidisciplinary committee including researchers, physicians, pharmacists, patients, and dispensary personnel planned study protocols. We plan to recruit 1000 participants aged ≥18 years with ~50% new and ~50% current MMJ patients from clinics and dispensaries. Consented participants will be compensated with a gift card for each survey completion. Survey domains include sociodemographic characteristics, physical and mental health, marijuana use history, reasons for MMJ use and discontinuation, MMJ products and use patterns, concurrent use of prescription medications and other substances, and side effects. We pilot-tested the questionnaires on 20 randomly selected participants from the Marijuana Center Contact Registry. We established a concept system to facilitate sharing and analysis of deidentified M3 data. Linkages with other databases are planned as well. Enrollment begins in May 2022.
Conclusion: The M3 databank will provide data to investigators affiliated with the consortium to enhance research to inform policy, clinical practice, and improvements in patient outcomes.