Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study
Significant knowledge gaps regarding the effectiveness and safety of medical cannabis (MC) create clinical challenges for MC physicians, making treatment recommendations and patients choosing treatment among the growing number of options offered in dispensaries. Additionally, data describing the cha...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Karger Publishers
2023-05-01
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| Series: | Medical Cannabis and Cannabinoids |
| Subjects: | |
| Online Access: | https://beta.karger.com/Article/FullText/530052 |
| _version_ | 1797808824177917952 |
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| author | Ruba Sajdeya Hannah J. Fechtel Gabriel Spandau Amie J. Goodin Joshua D. Brown Sebastian Jugl Nicole E. Smolinski Almut G. Winterstein Robert L. Cook Yan Wang |
| author_facet | Ruba Sajdeya Hannah J. Fechtel Gabriel Spandau Amie J. Goodin Joshua D. Brown Sebastian Jugl Nicole E. Smolinski Almut G. Winterstein Robert L. Cook Yan Wang |
| author_sort | Ruba Sajdeya |
| collection | DOAJ |
| description | Significant knowledge gaps regarding the effectiveness and safety of medical cannabis (MC) create clinical challenges for MC physicians, making treatment recommendations and patients choosing treatment among the growing number of options offered in dispensaries. Additionally, data describing the characteristics of people who use MC and the products and doses they receive are lacking. The Medical Marijuana and Me (M3) Study was designed to collect patient-centered data from MC users. We aim to describe preferred MC use patterns that patients report as “most effective” for specific health conditions and symptoms, identify user characteristics associated with such use patterns, characterize adverse effects, including cannabis use disorder, identify products and patient characteristics associated with adverse effects, describe concurrent prescription medication use, and identify concomitant medication use with potential drug-MC interaction risk. Among MC initiators, we also aim to quantify MC use persistence and identify reasons for discontinuation, assess MC utilization pattern trajectories over time, describe outcome trajectories of primary reasons for MC use and determine factors associated with different trajectories, track changes in concomitant substance and medication use after MC initiation, and identify factors associated with such changes. M3 is a combined study comprised of: (1) a prospective cohort of MC initiators completing surveys at enrollment, 3 months, and 9 months after MC initiation and (2) a cross-sectional study of current MC users. A multidisciplinary committee including researchers, physicians, pharmacists, patients, and dispensary personnel designed and planned study protocols, established study measures, and created survey questionnaires. M3 will recruit 1,000–1,200 participants aged ≥18 years, with ∼50% new and ∼50% current MC patients from MC clinics across Florida, USA. Study enrollment started in May 2022 and will continue until the target number of patients is achieved. Survey domains include sociodemographic characteristics, physical and mental health, cannabis use history, reasons for MC use and discontinuation, MC products and use patterns, concurrent use of prescription medications and other substances, and side effects. Data collected in the M3 Study will be available for interested researchers affiliated with the Consortium for Medical Marijuana Clinical Outcomes Research. The M3 Study and Databank will be the largest cohort of current and new MC users in Florida, USA, which will provide data to support MC-related health research necessary to inform policy and clinical practice and ultimately improve patient outcomes. |
| first_indexed | 2024-03-13T06:43:26Z |
| format | Article |
| id | doaj.art-8776939cf09d4dbbb96fe8bb13871734 |
| institution | Directory Open Access Journal |
| issn | 2504-3889 |
| language | English |
| last_indexed | 2024-03-13T06:43:26Z |
| publishDate | 2023-05-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Medical Cannabis and Cannabinoids |
| spelling | doaj.art-8776939cf09d4dbbb96fe8bb138717342023-06-08T12:42:07ZengKarger PublishersMedical Cannabis and Cannabinoids2504-38892023-05-0161465710.1159/000530052530052Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) StudyRuba Sajdeya0https://orcid.org/0000-0002-1101-3603Hannah J. Fechtel1https://orcid.org/0000-0001-9428-4443Gabriel Spandau2Amie J. Goodin3https://orcid.org/0000-0002-0020-8720Joshua D. Brown4Sebastian Jugl5https://orcid.org/0000-0002-1244-1423Nicole E. Smolinski6https://orcid.org/0000-0002-0866-4579Almut G. Winterstein7https://orcid.org/0000-0002-6518-5961Robert L. Cook8Yan Wang9Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USADepartment of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USAConsortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL, USADepartment of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USADepartment of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USASignificant knowledge gaps regarding the effectiveness and safety of medical cannabis (MC) create clinical challenges for MC physicians, making treatment recommendations and patients choosing treatment among the growing number of options offered in dispensaries. Additionally, data describing the characteristics of people who use MC and the products and doses they receive are lacking. The Medical Marijuana and Me (M3) Study was designed to collect patient-centered data from MC users. We aim to describe preferred MC use patterns that patients report as “most effective” for specific health conditions and symptoms, identify user characteristics associated with such use patterns, characterize adverse effects, including cannabis use disorder, identify products and patient characteristics associated with adverse effects, describe concurrent prescription medication use, and identify concomitant medication use with potential drug-MC interaction risk. Among MC initiators, we also aim to quantify MC use persistence and identify reasons for discontinuation, assess MC utilization pattern trajectories over time, describe outcome trajectories of primary reasons for MC use and determine factors associated with different trajectories, track changes in concomitant substance and medication use after MC initiation, and identify factors associated with such changes. M3 is a combined study comprised of: (1) a prospective cohort of MC initiators completing surveys at enrollment, 3 months, and 9 months after MC initiation and (2) a cross-sectional study of current MC users. A multidisciplinary committee including researchers, physicians, pharmacists, patients, and dispensary personnel designed and planned study protocols, established study measures, and created survey questionnaires. M3 will recruit 1,000–1,200 participants aged ≥18 years, with ∼50% new and ∼50% current MC patients from MC clinics across Florida, USA. Study enrollment started in May 2022 and will continue until the target number of patients is achieved. Survey domains include sociodemographic characteristics, physical and mental health, cannabis use history, reasons for MC use and discontinuation, MC products and use patterns, concurrent use of prescription medications and other substances, and side effects. Data collected in the M3 Study will be available for interested researchers affiliated with the Consortium for Medical Marijuana Clinical Outcomes Research. The M3 Study and Databank will be the largest cohort of current and new MC users in Florida, USA, which will provide data to support MC-related health research necessary to inform policy and clinical practice and ultimately improve patient outcomes.https://beta.karger.com/Article/FullText/530052medical marijuanammjclinical outcomeseffectivenessmedical cannabis |
| spellingShingle | Ruba Sajdeya Hannah J. Fechtel Gabriel Spandau Amie J. Goodin Joshua D. Brown Sebastian Jugl Nicole E. Smolinski Almut G. Winterstein Robert L. Cook Yan Wang Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study Medical Cannabis and Cannabinoids medical marijuana mmj clinical outcomes effectiveness medical cannabis |
| title | Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study |
| title_full | Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study |
| title_fullStr | Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study |
| title_full_unstemmed | Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study |
| title_short | Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M3) Study |
| title_sort | protocol of a combined cohort and cross sectional study of persons receiving medical cannabis in florida usa the medical marijuana and me m3 study |
| topic | medical marijuana mmj clinical outcomes effectiveness medical cannabis |
| url | https://beta.karger.com/Article/FullText/530052 |
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