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To evaluate the prevalence of cannabis use for MS symptom management and factors associated with its use among current users in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry. An online, supplemental survey regarding use of tetrahydrocannabinol (THC)-containing cannabis for MS symptoms. A voluntary, self-report registry for PwMS. Active, US NARCOMS participants (N=6934), of whom 3249 (47%;) responded to the survey. Not applicable. The prevalence of, and reasons for, using or not using cannabis, as well as behaviors and attitudes of current users. Findings were summarized using descriptive statistics. The proportion of respondents who reported using cannabis for MS symptoms was 31%. Among the 69% of respondents who did not use cannabis for MS symptoms, the most common reasons were insufficient efficacy (40%) or safety (27%) data. Overall, 636 respondents (20%) reported current use (within last 30 days). Smoking (33%) and eating (20%) were the two most common primary modes of administration. A portion of current users started cannabis before using a prescribed MS symptom management drug (23%) or rehabilitation therapy (45%). The most common target symptoms were spasticity (80%), pain (69%), and sleep problems (61%). Of the 511 current users treating spasticity, 321 (63%) were using additional symptom management therapies (59% using drugs; 11% using physical/occupational therapy) and 190 (37%) were using only cannabis. Although concerns about efficacy, safety, and other factors prevent some PwMS from trying cannabis, 31% have tried and 20% are currently using non-FDA-approved cannabis products for MS symptom relief. Of those currently using cannabis to treat spasticity, over a third were using only cannabis. Funding: Greenwich Biosciences, Inc. Joanne Wagner, Kathryn Nichol, and Joshua Steinerman have a financial relationship with Greenwich Biosciences. Amber Salter has nothing to disclose. Robert Fox has a financial relationship with AB Science, Actelion, Biogen, Celgene, EMD Serono, Genentech, Immunic, Novartis, Sanofi, and TG Therapeutics. Gary Cutter has a financial relationship with Antisense Therapeutics, Astra-Zeneca, Avexis Pharmaceuticals, Biodelivery Sciences International, Biogen, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, Click Therapeutics, CSL Behring, Galmed Pharmaceuticals, Genentech, Genzyme, GreenValley Pharma Ltd, GW Pharmaceuticals, Klein-Buendel Incorporated, Mapi Pharmaceuticals LTD, Medday, Medimmune/Viela Bio, Merck, Merck/Pfizer, Merck/Serono, Immunic, Neurim, Neurogenesis LTD, Novartis, Novartis, OncoImmune, Ophazyme, Opko Biologics, Osmotica Pharmaceuticals, Perception Neurosciences, Reata Pharmaceuticals, Reckover Pharmaceuticals, Recursion/Cerexis Pharmaceuticals, Regeneron, Roche, SAB BIotherapeutics, Sanofi-Aventis, Teva pharmaceuticals, TG Therapeutics, VielaBio Inc, and Vivus. Karry Smith has a financial relationship with Abbott/St Jude, Boston Scientific, Greenwich Biosciences, and Medtronic. [ABSTRACT FROM AUTHOR]

To develop a conceptual model of spasticity in MS that integrates the experience of persons with MS (pwMS) and clinicians, in accordance with Food and Drug Administration guidance on patient-focused drug development. Targeted literature review of published articles (2014–2019) and input from three spasticity clinical experts (MC, FB, EFF) followed by one-time interviews with a separate group of three clinicians experienced in spasticity treatment/research and semi-structured interviews with pwMS. Patient interview data were collected until concept saturation (no new information provided on successive interviews). Iterative feedback from the three clinical experts and GW spasticity research team guided further refinements. Phone interviews. Three clinical experts; 3 clinicians experienced in spasticity treatment/research; 20 patients with MS ≥12 months and spasticity ≥6 months. Not applicable. Key concepts of MS spasticity included objective manifestations; subjective patient experiences; triggers; moderators; physical, functional, emotional, and social impacts; and long-term consequences. Of 282 abstracts reviewed, 23 full-text articles were used to develop the draft model. The interviewed pwMS were on average 47.3 years old and had self-reported spasticity for an average 12.3 years. Spasms, pain, and stiffness were spasticity descriptors most frequently endorsed by both pwMS and the literature. Some pwMS had difficulty distinguishing spasticity from other MS symptoms (e.g., muscle weakness, tremor, numbness). Some triggers (e.g., skin lesions, constipation, stress), emotional impacts (e.g., embarrassment, frustration), and long-term consequences of spasticity (e.g., loss of employment or driving ability) were reported by pwMS but not in the recent literature. MS Spasticity is complex, multidimensional, and heterogeneous. Clinicians and pwMS may use different descriptors. This integrated conceptual model may enhance future research and management of spasticity in pwMS. Francois Bethoux has a financial relationship with Adamas Pharmaceuticals, Biogen, Genentech, Greenwich Biosciences, Helius Medical, MedRhythms, Osmotica Pharmaceuticals, Qr8, and Springer Publishing. Michelle Cameron has a financial relationship with Adamas Pharmaceuticals, Greenwich Biosciences, and Helius Medical. William R. Lenderking has a financial relationship with Evidera. Erica Zaiser and Katelyn N. Cutts have a financial relationship with Evidera. Joshua R. Steinerman, Joanne Wagner, and Edelle Field-Fote have a financial relationship with Greeenwich Biosciences. [ABSTRACT FROM AUTHOR]