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Abstract

Background and Objectives

As cannabis products become increasingly accessible across the United States, understanding how patients obtain medical information on cannabis and view the role of their health care provider in providing information is important.

Methods

Participants with multiple sclerosis (MS) from the North American Research Committee on Multiple Sclerosis registry completed a supplemental survey on Δ9-tetrahydrocannabinol-containing cannabis use between March and April 2020. Participants reported dialogue with health care providers regarding cannabis use, information sources used to make product decisions, and expenditure on cannabis. Findings are reported using descriptive statistics.

Results

Overall, 3,249 participants responded (47% response rate), of whom 31% ever used cannabis and 20% currently used cannabis for MS. To determine presumed cannabis contents, respondents who had ever used cannabis (ever users) most often used dispensary-provided information (39%), word of mouth/dealer/friend (29%), and unregulated product labels (24%). For general information on cannabis for MS, ever users most often used dispensary staff (38%) and friends (32%). The primary source of medical guidance among ever users was most often “nobody or myself” (48%), followed by a dispensary professional (21%); only 12% relied on their MS physician, although 70% had discussed cannabis with their MS physician. Most current users (62%) typically sourced their cannabis from a dispensary. The most common factor in selecting a cannabis product was perceived quality and safety (70%).

Discussion

Participants most often received information on cannabis for MS from dispensaries, unregulated product labels, and friends; only a small proportion used health care providers. Evidence-based patient and physician education is needed.
Interest in cannabis use for symptom management in neurologic conditions, such as multiple sclerosis (MS) and epilepsy,1,2 is increasing as more data become available and access eases from a legal perspective.3,4
Among people with MS (PwMS), the high prevalence of pain, sleep disturbance, and comorbid symptoms, coupled with the lack of sufficiently effective treatment options for those symptoms, there has been increased interest in cannabis products.5 In our 2020 survey of participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) self-report registry, 31% of PwMS had ever used cannabis to treat MS symptoms, and 20% had used cannabis within 30 days of survey administration.6 The survey definition of cannabis/marijuana did not include products marketed as only cannabidiol (CBD) or hemp CBD.
The source of patient information about cannabis products is relatively unknown. We report how PwMS communicate about cannabis use with their health care providers, which information sources they use to make product decisions, the types of product they are choosing, and how much they spend on cannabis products. We hypothesized that participants in our NARCOMS survey obtained cannabis product information and medical guidance from sources other than their health care provider.

Methods

Study Design

The NARCOMS registry is a voluntary self-report registry for PwMS.7 Participants are asked to update their information semiannually. Participants may also be invited to participate in supplemental surveys.
Active, US-based participants as of February 28, 2020 (N = 6,934) were invited to participate in this online supplemental survey; no other eligibility criteria were applied. The survey was conducted using REDCap hosted at Washington University.8

Standard Protocol Approvals, Registrations, and Patient Consents

The survey was approved by the Washington University Institutional Review Board. By responding to the survey, participants gave informed consent to participate in the research. As cannabis use is not legal throughout the United States, NARCOMS obtained a certificate of confidentiality9 to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research, except when the subject consented, or in limited other specific situations.

Demographic and Clinical Data

For participants who agreed to link their existing information with the cannabis survey, their semiannual update responses from 2019 were used to ascertain annual household income, employment status, alcohol use, smoking status, region of residence, disability status, clinical course, and disease-modifying therapy (DMT) use (yes/no).
Annual household income was reported as <$15,000, $15,000–$30,000, $30,001–$50,000, $50,001–$100,000, >$100,000, or “I do not wish to answer.” Current employment status was categorized as full time, part time, or not employed. Alcohol use was categorized as never, monthly or less, 2–4 times per month, 2–3 times per week, or >4 times per week. Smoking status was categorized as not at all, some days, or every day. Region of residence was categorized as to whether the use of cannabis for medical purposes was currently legal.10 Disability status was categorized using the Patient Determined Disease Steps: normal, mild disability, moderate disability, gait disability, early cane, late cane, bilateral support, wheelchair/scooter, and bedridden. Clinical course was categorized as clinically isolated syndrome, relapsing-remitting, secondary progressive, primary progressive, do not know or unsure, MS diagnosis not confirmed by a physician, or other. Methodology relating to demographics information collected has been previously reported.6

Cannabis Use

Participants were instructed that in this survey, “cannabis/marijuana” referred to products derived from the cannabis/marijuana plant and did not include products marketed as only CBD or hemp CBD. This will be henceforth referred to as simply “cannabis.” Where possible, questions regarding cannabis were sourced from national US surveys11-14 to ensure that the questions were validated6 and enhance comparability.

Information Sources

Participants who reported ever using cannabis indicated what information they used to determine the cannabis product contents used to treat MS symptoms: the product label, product website, certificate of analysis, dispensary-provided information, word of mouth/dealer/friend, health care provider, or other. They also reported where they obtained general information about how to use cannabis as follows: health care provider, dispensary staff, product packaging or website, internet, friends, scientific publications, advocacy group, online communities, or other.

Medical Guidance on Cannabis Use

Participants reported the primary person who provided them with medical guidance regarding cannabis use as follows: physician (MS provider or other physician), other licensed health care professional, pharmacist, dispensary professional, other patients with MS, or nobody/myself.
Participants reported whether they had discussed their cannabis use to treat MS symptoms with their MS physician, and whether they would feel comfortable discussing their cannabis use with this physician as follows: “yes, very comfortable,” “yes, comfortable,” “no, uncomfortable,” and “no, very uncomfortable.” Participants reported potential reasons for not feeling comfortable discussing cannabis with their MS physician including the belief that the physician would not approve of the cannabis use, concerns around stigma of raising this topic, discomfort initiating the conversation around cannabis use, not being interested in discussing it/lack of relevance, or the physician having never raised the topic. All participants reported whether they thought that their MS provider would feel comfortable with their cannabis use as follows: believing that the physician would be/is comfortable with it, would not be/is not comfortable with it, or that they would/would not be comfortable with it if the participant used cannabis.

Participant Preferences

Participants reported their typical source of cannabis as follows: I grow my own, someone grows it for me, from a dispensary, online, from an acquaintance, from a family member or friend, from a dealer, or other. They also reported the most important factors when selecting a source from which to purchase cannabis (such as low price, quality and safety, sales support, location, accessibility, ability to purchase online, anonymity/discretion, access to preferred potency/formulation, access to preferred strain, and access to products not available in licensed stores or online).

Spending on Cannabis

Participants reported how much they spend on cannabis in an average month. Options included nothing, $1–$10, $11–$25, $26–$50, $51–$100, $101–$150, $151–$250, $251–$500, $501–$750, $751–$1,000, or >$1,000.

Statistical Analysis

Descriptive statistics were used to summarize responses with mean (SD) or median (25th, 75th percentiles) for continuous variables and frequency (percentage) for categorical variables. Differences between groups were determined by the t test or Wilcoxon test for continuous variables and χ2 or Fisher exact test, as appropriate, for categorical variables. The association between legal medical use of cannabis and physician comfort and dialogue among never vs ever and past vs current users was examined using a Cochran-Mantel-Haenszel test.

Data Availability

Patient-level data cannot be provided in keeping with the certificate of confidentiality, but aggregated data that support these findings will be made available to qualified researchers on request to the corresponding author.

Results

Participants

Of the 6,934 invited participants, 3,249 (46.9%) responded, of whom 3,240 (99.7%) responded to the item regarding cannabis use for MS (Figure 1). Small differences between respondents and nonrespondents to the survey in the NARCOMS population were identified for age, race, and education level.6
Figure 1 Survey Respondents Flow Diagram
As reported previously,6 most respondents were female and White (Table 1). Approximately two-thirds had a bachelor's degree or higher and were unemployed. The mean (SD) age was 61.3 (10.0) years; the mean (SD) age at MS symptom onset was 31.2 (10.3) years; and the median (25th, 75th percentile) disability level was 3-Gait Disability (1-Mild Disability, 6-Bilateral Support). Almost two-thirds of the respondents were taking a DMT. Most respondents (76.1%) lived in a state where the medical use of cannabis was currently legal, and 55.3% of respondents used cannabis before their MS diagnosis.
Table 1 Demographics and Clinical Characteristics

Cannabis Use

Of the 3,240 respondents, 1,012 (31%) reported ever using cannabis to treat MS symptoms (ever users), 636 (20%) reported current use (current users [within 30 days of the survey]), 376 (12%) reported past use (past users), and 2,228 (69%) reported having never used it (never users). A higher proportion of ever users resided in a state where cannabis use was currently legal compared with never users (81.2% vs 73.7%, p < 0.0001) and between current and past users (84.0% vs 76.6%, p = 0.009).

Information Sources

To determine cannabis contents, ever users were most likely to use dispensary-provided information (39%), word of mouth/dealer/friend (29%), and unregulated product label (24%) (Table 2). Among ever users, current users were more likely than past users to determine contents from dispensary-provided information (45% vs 29%; p < 0.001) and the unregulated product label (27% vs 18%; p = 0.002).
Table 2 Product Information Sources and Primary Medical Guidance on Cannabis Use Among Ever, Past, and Current Users
To obtain general information about cannabis use for MS, <15% of ever users relied on health care providers; instead, dispensary staff (38%) and friends (32%) were the most frequently reported sources (Table 2). Current users vs past users more often cited dispensary staff (43% vs 30%; p < 0.001) and the internet (20% vs 13%; p = 0.007) as sources of information on using cannabis for MS.
The primary source of medical guidance among the 1,012 ever users was most often cited as “nobody or myself” (48%), followed by a dispensary professional (21%) (Table 2). Only 112 (12%) relied on their MS physician (Figure 2), with no difference between past and current users. Current users were more likely than past users to rely on a physician different from their MS provider (11% vs 4.6%; Table 2).
Figure 2 Proportion of Participants Who Have Discussed Cannabis Use With/Sought Medical Guidance From Their MS Physician
Proportion of participants who have discussed their cannabis use with the physicians who treat their MS compared with the proportion of participants who have sought medical guidance around cannabis use from their MS physician (ever, past, and current users). MS = multiple sclerosis.
Of the ever users, most (70%) had discussed cannabis with the physician who treats their MS (Figure 2). The proportion of participants who discussed cannabis with their physician was higher among current users vs past users (75% vs 60%; p < 0.001).

Comfort and Dialogue With Physician

Of the 3,240 total respondents, 1,755 (56%) reported being very comfortable discussing cannabis use for symptom management with their MS physician (Table 3). More ever users (72%) reported feeling very comfortable than never users (50%) (p < 0.001). More current users were likely to feel very comfortable (74%) than past users (67%) (p = 0.042).
Table 3 Physician Communication Regarding Cannabis Use Among Never, Ever, Past, and Current Users
Among ever users, a small minority provided reasons for not feeling comfortable discussing cannabis with their MS provider, including a belief that their MS physician does not approve of cannabis use (3.4%), concern about the stigma of raising this topic with their MS physician (3.2%), or that their MS physician had never raised the topic of cannabis (2.9%).
More ever users than never users responded positively to questions regarding their care providers beliefs, except for the question “I am not interested in discussing it/it is not relevant to me,” where more never users answered “yes” compared with ever users (9.6% vs 1.2%; p < 0.001). For the option “My MS physician has never raised the topic of cannabis,” never and ever users did not differ significantly (“yes” answers: 4.2% vs 2.9%; p = 0.070). Responses did not differ significantly between past and current users, except for “I am not interested in discussing it/it is not relevant to me,” where a higher percentage of past users answered “yes” than current users (2.7% vs 0.3%; p < 0.001).
Most never and ever users believed that their MS physician would be comfortable with their cannabis use (66% and 78%). Among ever users, more past users vs current users believed that their MS physician would not be comfortable with their cannabis use (29% vs 19%; p < 0.001). Residence in a state where cannabis use was currently legal was associated with more frequent belief that their MS physician would be comfortable with cannabis use (eTable 1, links.lww.com/CPJ/A326).

Product Preferences, Sources, and Cost

Of the 636 current users, 393 (62%) typically source cannabis from a dispensary, 112 (18%) from a family member or friend, and 82 (13%) from an acquaintance (eFigure 1, links.lww.com/CPJ/A326).
The most common factor in selecting a source to purchase cannabis was perceived quality and safety (n = 448 [70%]), followed by access to preferred Δ9-tetrahydrocannabinol (THC) and/or CBD potencies/formulations (n = 252 [40%]), location (n = 246 [39%]), and sales support (n = 194 [31%]) (eFigure 2, links.lww.com/CPJ/A326).
Spending per month on cannabis was reported as nothing (get it for free or trade) for 11% of participants, $1–$25 for 17%, $26–$50 for 18%, $51–$100 for 24%, $101–$250 for 23%, $251–$500 for 6%, and $501–$1,000 for 1%.

Discussion

The prevalence of cannabis use by PwMS is rising.5,15 Although one-third of respondents reported ever using cannabis to treat MS symptoms, 20% reported current use. Ever use and current use of cannabis were higher in this survey compared with previous NARCOMS reports,13 possibly reflecting increasing acceptance of cannabis use and/or the increasing number of states with legalized cannabis possession and use.
Sources of information used by PwMS broadly reflected where participants acquired cannabis products, which was most often a dispensary. Family, friends, acquaintances, dealers, and word of mouth were also reported as product information sources, but <10% of participants reported obtaining product information from health care providers. In another recent survey of cannabis use in PwMS in the United States, <1% of participants received assistance from their provider regarding selection of cannabinoid formulations.5
Participants reported low reliance on their physicians for medical guidance regarding cannabis use. In another recent survey of cannabis use in PwMS in the United States, 18% of participants reported discussing cannabinoids for MS symptom management with a health care provider.5 The low reliance on clinicians for guidance on therapeutic cannabis use may reflect the lack of a prescription product in the United States. Also, clinicians generally lack knowledge of the THC, CBD, and other contents of specific cannabis products and data regarding efficacy, safety, dosing, and patient selection and therefore may not provide guidance, even while remaining open to more general discussion of cannabis. Moreover, despite PwMS being comfortable discussing cannabis use, a substantial minority believe that their MS physician would not be comfortable with their cannabis use, particularly in states where use was not currently legal, and are therefore unlikely to seek medical guidance on the topic. These findings have important implications for clinical care of PwMS taking cannabinoids, highlighting the gap between the rapid dissemination of informal sources of information on cannabis products compared with less accessible (though more trustworthy) health care provider–based information.16
Ongoing physician education is recognized as important to the “shared decision-making” paradigm, to provide patients with the most current information.17 This model has been implemented in MS care, in which the clinician and patient decide on DMT regimens together, considering the patient's individual needs, preferences, and values.18 Despite the prevalence of cannabis use among PwMS, lack of health care provider knowledge or awareness may hamper decision making in MS care. A recent cross-sectional analysis of health care provider's knowledge regarding cannabis use for medical purposes indicated considerable gaps in knowledge regarding clinical effects, risks and harms, pharmacology, and effects on pain, MS spasticity, and seizures.19 A recent survey supports this idea, with most Australian general practitioners feeling that their knowledge of medical cannabis was inadequate, and only 29% feeling comfortable discussing cannabis use with patients.20 Consistent with those studies, our findings highlight the need for further education of health care providers regarding the risks and benefits of cannabis and cannabinoid use.
PwMS often have symptom management regimens and may also take herbal and other supplements.21,22 Thus, the possibility of pharmacologic interactions is high.23 CBD and THC affect common targets for drug metabolism (such as cytochrome P450 [CYP]3A4/2C19 enzymes), which may affect the pharmacokinetics/pharmacodynamics of other drugs that interact with these pathways.24,25 CBD or marijuana use decreases clearance of drugs and their metabolites that use CYP2C19 (e.g., warfarin), increases clearance of CYP1A2-metabolized drugs, and may result in adverse additive effects in combination with sympathomimetics (e.g., hypertension), alcohol and opioids (e.g., ataxia), and anticholinergics (e.g., tachycardia).25 Thus, it is important that health care providers are aware of all concomitant therapies and that patients are comfortable discussing their cannabis use with their MS physician.
Although informal sources of information were reported, participants cited quality and safety as the most important factor in selecting products, followed by preferred THC and/or CBD potencies/formulations, location, and sales support. This suggests that PwMS are eager to have more information, but the lack of adequate controlled studies makes it difficult for PwMS to obtain medical guidance regarding a specific THC:CBD ratio or dose. Furthermore, content in unregulated products frequently does not match the label.26-28
This survey has several limitations. NARCOMS is a voluntary registry, so may not represent the general MS population. However, the participant population has an age distribution close to the peak age in MS prevalence previously reported.29 Women were overrepresented in this study with a female to male ratio of 3.6:1, even after accounting for the greater prevalence of MS in women than in men (2.6:1).29 Despite stringent efforts to ensure confidentiality, response bias may have affected some responses. As this was a single survey, it represents a snapshot in time; patterns of cannabis use and the trends discussed in this article are likely to be dynamic. Our comparisons of information sources across groups (e.g., current and past users) cannot account for obtaining that information at different points in time nor for changes in the type or accessibility of information provided by dispensaries. Additionally, we do not know if cannabis use was legal in a participant's state at the time of use as laws have rapidly changed recently. Only data for use of cannabis products (containing THC in addition to CBD and excluding products reported to contain CBD alone) were collected. We were unable to evaluate whether PwMS would use cannabis less often if studies were to show a harmful impact in MS, but this warrants future study once randomized trials are performed and published. The analyses were limited by incomplete responses for some elements. Health care providers' perspectives regarding their comfort in discussing cannabis use for MS were not captured. A recent systematic review suggested that practitioners, although generally supportive of the use of medicinal cannabis, self-perceived a lack of knowledge and limited accessible information as barriers.30 A survey of Canadian physicians showed that over two-thirds would feel more comfortable discussing medical cannabis with their patients if they had access to more formal education on the topic.31
Our findings indicate that PwMS use “informal” sources for information on cannabis products. Involvement of health care providers in decision making surrounding cannabis use by PwMS is limited, despite patient willingness to discuss cannabis with providers. Evidence-based education is needed to increase clinician knowledge, and further information is needed to determine what is most needed to take a more active role in providing medical guidance to their patients.

Acknowledgment

The authors acknowledge and thank Dr. Lesley Taylor of Alchemy Medical Writing Ltd. for medical writing and editorial support, which was funded by Greenwich Biosciences, Inc. NARCOMS is a project of the Consortium of Multiple Sclerosis Centers (CMSC) and the Foundation of the CMSC.

Appendix Authors

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Information & Authors

Information

Published In

Neurology® Clinical Practice
Volume 12Number 2April 2022
Pages: 102-112

Publication History

Received: October 18, 2021
Accepted: January 5, 2022
Published online: January 20, 2022
Published in print: April 2022

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Disclosure

K.M.J. Smith, J.R. Steinerman, and K.E. Nichol are, or were, employees of Greenwich Biosciences. R.A. Marrie receives research funding from the CIHR, Research Manitoba, Multiple Sclerosis Society of Canada, Multiple Sclerosis Scientific Research Foundation, Crohn's and Colitis Canada, National Multiple Sclerosis Society, CMSC, the US Department of Defense, Biogen Idec, and Roche. She is supported by the Waugh Family Chair in Multiple Sclerosis. A. Salter receives research funding from the CMSC and National Multiple Sclerosis Society. R.J. Fox receives personal consulting fees from AB Science, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Immunic, Janssen, Novartis, Sanofi, and TG Therapeutics; serves on advisory committees for Actelion, Biogen, Immunic, Novartis, and Sanofi; and receives clinical trial contract and research grant funding from Biogen, Novartis, and Sanofi. G. Cutter: Data and Safety Monitoring Boards—AstraZeneca, Avexis Pharmaceuticals, BioLineRx, Brainstorm Cell Therapeutics, Bristol-Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Mapi Pharmaceuticals LTD, Merck, Merck/Pfizer, Mitsubishi Tanabe Pharma Holdings, Opko Biologics, Neurim, Novartis, Ophazyme, Sanofi Aventis, Reata Pharmaceuticals, Teva Pharmaceuticals, VielaBio Inc, NHLBI (Protocol Review Committee), and NICHD (OPRU oversight committee); consulting or advisory boards: Alexion, Antisense Therapeutics, Biodelivery Sciences International, Biogen, Clinical Trial Solutions LLC, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein Buendel Incorporated, MedImmune/Viela Bio, MedDay, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Protalix Biotherapeutics, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, SAB Biotherapeutics, and TG Therapeutics. Dr. Cutter is employed by the University of Alabama at Birmingham and President of Pythagoras, Inc., a private consulting company located in Birmingham AL. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp.

Study Funding

Greenwich Biosciences, Inc., provided funding for the supplemental survey.

Authors

Affiliations & Disclosures

UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
(1) DSMB for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 (2) OSMB for Central Vein Sign: A Diagnostic Biomarker in Multiple Sclerosis
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Circulation: Cardiovascular Imaging, Statistical Editor, 2018- 2021 Neurology, Editorial board member, 2021
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
(1) Department of Defense, Principal Investigator, 2021-2024
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Consortium of Multiple Sclerosis Centers (2) National Multiple Sclerosis Society
Stock/stock Options/board of Directors Compensation:
1.
NONE
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Gary Cutter, PhD
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
Data and Safety Monitoring Boards: AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Immunic, Mapi Pharmaceuticals LTD, Merck, Merck/Pfizer, Mitsubishi Tanabe Pharma Holdings, Opko Biologics, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, Teva pharmaceuticals, VielaBio Inc, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee).
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Multiple Sclerosis Journal: editorial board, (11 yrs); Multiple Sclerosis and Related Disorders: Editorial board; (1 yr);Am journal of the Society of Nephrology. Statistical editor; contributing statistical help (6 yrs); Alzheimer's and Dementia (5) yrs; Neurology Clinical Practice (7yrs);
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Alexion, Antisense Therapeutics, Biogen, Clinical Trial Solutions LLC, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio/Horizon Pharmaceuticals, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Protalix Biotherapeutics, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche.Therapeutics.
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
President of Pythagoras Inc. a consulting company
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
U01 AR071133 (Bammam) 12/6/2016 – 11/30/2022 6 calendar NIH/NIAMS $ 6,942,009 (total funds) The Exercise and Physical Activity Collaborative Team (ExPact): A Proposed MoTrPAC Clinical Center The goals are to help lead the NIH Common Fund initiative – Molecular Transducers of Physical Activity Consortium (MoTrPAC) – by serving as one of six adult clinical centers conducting a large-scale, randomized, controlled trial (RCT) of resistance vs. aerobic exercise training vs. no-exercise control. The RCT will be complemented by molecular acute response studies in RCT participants as well as highly trained athletes; all with the goal of generating molecular maps that reveal key underpinnings of exercise-induced health benefits. No Number (Motl) 01/01/2020 – 06/30/2021 .87 calendar Consortium of Multiple Sclerosis Centers $39,996 total costs Examining Patterns and Correlates of Wellness in Persons with Multiple Sclerosis who use Wheelchairs 5U54NS115054 (PI: Kaminski, sub-PI: Cutter) 09/01/2019 – 05/31/2024 0.6 calendar NIH/NINDS $321,265 total costs Rare Disease Network for Myasthenia Gravis We propose development of the Myasthenia Gravis Clinical Research Consortium (MGNet) to coordinate investigators in collection of detailed clinical information and biological specimen along with performance of pilot investigations of a therapeutic and biomarker discovery. We link our efforts to a program to develop new investigators in myasthenia gravis. This is all done with the purpose of enhancing performance clinical trials and care of patients to one day find a cure for myasthenia gravis. 5R01AG057684 (Kennedy) 09/15/2017 – 03/31/2022 0.12 calendar NIH/NIA $3,242,015 total costs In Silico Screening of Medications for Slowing Alzheimer’s Disease Progression In this proposal, we will explore drug repurposing, in which medications approved to treat other illnesses are evaluated for potential benefits in Alzheimer's disease (AD), to improve the efficiency of the drug development process, which currently ends in failure for most candidate medications despite considerable investment of both time and resources. We will apply data mining, or pattern recognition, algorithms to the concomitant medications taken by subjects in previous AD clinical trials that are part of our meta-database of more than 6,500 individuals and by participants in Medicare Part D with more than 787,000 individuals. This approach will allow us to screen hundreds of drugs for effects in slowing the progression of AD, which will guide future clinical trials of novel therapeutic agents. 1U01HL119242 (PI: Szychowski) 09/01/2014 – 11/30/2021 .96 calendar NIH/NHLBI $2,744,642 total costs Chronic Hypertension and Pregnancy (CHAP): Data Coordinating Center CHAP is a pragmatic multi-center randomized trial of pregnant women with mild chronic hypertension to evaluate the benefits and harms of antihypertensive therapy to a goal <140/90 mmHg (as recommended for the general population in the US) compared with ACOG’s current policy of expectant management of mild chronic hypertension in pregnancy. The trial will enroll 2,404 women across more than 60 clinical sites. R01HD098132-01A1 (PI: Subramaniam) 01/20/2020 – 12/31/2024 .24 calendar NIH/NICHD $3,242,752 total costs Childhood Pulmonary and Related Outcomes after Perinatal Exposure to Adjunctive Azithromycin Prophylaxis for Cesarean Delivery (C/SOAP Follow-Up Study) We propose a US multi-center long-term follow-up study of children from the parent C/SOAP trial at age 6-8 years to evaluate childhood respiratory and gastrointestinal health effects after perinatal exposure to adjunctive azithromycin; findings from this study will be used to inform and strengthen national and global health care policy regarding the use of adjunctive azithromycin to reduce maternal infection after cesarean delivery. R01AI148359 (PI: Geisler) 05/11/2020 – 04/30/2025 0.6 calendar NIH/NIAID $3,201,254 total costs Host Immune Responses to Chlamydia trachomatis Candidate Vaccine Antigens and their Association with Clinical Correlates of Protective Immunity in Women Current chlamydia prevention and control efforts have been unable to reduce chlamydia infection rates, which provides strong rationale for development of a chlamydia vaccine to prevent chlamydia and its reproductive sequelae. This project will evaluate systemic and mucosal cellular and humoral immune responses induced by promising chlamydia vaccine candidate antigens and will assess association of the immune responses with clinical correlates of protection against chlamydia in women (spontaneous clearance of chlamydia and absence of reinfection after treatment). Findings may advance chlamydia vaccine development efforts and lead to formulation of these candidate antigens into a chlamydia vaccine for a phase I study. 5U01NS092595 (PI: Bebin) 06/01/2016 – 05/31/2022 0.24 calendar NIH/NINDS $7,084,395 total costs Preventing Epilepsy Using Vigabatrin in Infants with Tuberous Sclerosis Complex This study focuses on the developmental impact of early vigabatrin treatment in infants with Tuberous Sclerosis Complex who are at risk of developing epilepsy. Also, the study aims to determine the effectiveness of early vigabatrin treatment in clinical seizure prevention and its impact on the development of drug resistant epilepsy at 24months of age. This is the first seizure prevention trial in patients with TSC in the United States. 1R01HD088646 (PI: Katheria, sub PI: Szychowski) 04/01/2017- 03/31/2022 0.6 CM NIH/NCHHD $547,854 (total funds) Premature Infants Receiving Cord Milking Or Delayed Cord Clamping Delayed cord clamping reduces overall bleeding in the brain of premature infants, but not the most severe types. “Milking” the umbilical cord, a method used to transfer blood from the placenta into the baby before the umbilical cord is clamped, may provide additional blood volume to the brain and other vital organs thereby reducing bleeding in the brain and improving long-term outcomes in premature babies. This study will determine whether umbilical cord milking reduces bleeding in the brain or death in premature newborns delivered by Cesarean section compared to delaying clamping of the umbilical cord. P30DK079337 (PI: Agarwal) 08/01/2018 – 07/31/2023 1.77 CM NIH/NIDDK $1,136,699 (total funds) O’Brien Center for Acute Kidney Injury Research Acute kidney injury (AKI) is a major cause for morbidity and mortality in hospitalized patients and is being increasingly recognized as a cause for chronic kidney disease. AKI doubles the length of stay in the hospital, increasing health care resources. The UAB-UCSD O'Brien Center has brought together a team of investigators to serve unmet needs of our investigator base and to fill the gaps in knowledge in the field of AKI and AKI-related research. K23HD091849 (Gerstenecker) 09/12/2018 – 08/31/2023 0 calendar, Co-Mentor NIH/NICHHD $630,875 total costs Investigating the Impact of Cognition on Capacity in Multiple Sclerosis At a time in which increased cognitive ability is needed to make complex financial and medical decisions, people with MS are often experiencing cognitive decline; surprisingly though, research into the ability of people with MS to make complex financial and medical decisions is rare. This study proposes to investigate financial and medical decisional capacity and its clinical and neuroanatomical correlates in people with relapsing- remitting MS and progressive MS. The ultimate value of this research will be to act as a necessary first-step in the development of a targeted capacity rehabilitation program for people diagnosed with MS. K23HL127100 (Lebensburger) 04/01/2015 – 03/31/2021 0 calendar, Mentor NIH/NHLBI $916,445 total costs Chronobiology and Chronopharmacology to Prevent Sickle Cell Nephropathy Hypertension is a known risk factor for stroke in sickle cell disease and in other diseases associated with adverse cardiovascular outcomes. Within the context of a feasibility trial, this proposal will develop vital background data to understand the acceptability of, adherence to, and dosing strategy for losartan prior to conducting a definitive trial for adolescent sickle cell disease patients with abnormal circadian blood pressure. A prospective cohort study will also be conducted to define the relationship of urine and blood biomarkers on the development of abnormal nocturnal blood pressure dipping and kidney injury. PENDING OSP 532909 (Lal) 04/01/2022 – 03/31/2027 0.6 CM NIH $935,194 Optimization of Saturation Targets and Resuscitation Trial (OptiSTART) R34HL157412 (Leesar) 04/01/2021 – 03/31/2024 0.6 CM NIH/NHLBI $668,250 total costs Effects of Crushed Ticagrelor and no Fentanyl Versus Eptifibatide Bolus+Ticagrelor and Fentanyl in Patients with NSTE-ACS Undergoing Early PCI: A randomized Trial (CTEP trial) R21HD104996 (Rogers) 09/01/2021 – 08/31/2023 0.6 CM NIH $408,375 total costs Microbiome as a Novel Mechanism of Exercise Training Effects in Multiple Sclerosis R01HL154109 (Sanders) 04/01/2021 – 03/31/2026 0.6 CM NIH/NHLBI $2,929,087 total costs Dietary Sodium & Potassium and Aortic Stiffness R01TR003741 (Danila) 04/01/2021 – 03/31/2024 0.6 CM NIH/NCATS $2,937,048 total costs Digital Health for Rheumatology Care in COVID19 Era OSP 532630 (Motl) 06/01/2021 – 05/31/2024 0.6 CM Bristol-Myers Squibb Foundation, Inc. $770,799 total costs Exercise Promotion and Outcomes Among African-Americans with Multiple Sclerosis Living in Rural Communities OSP 533051 (Leesar) 04/01/2022 – 03/31/2025 0.6 CM NIH/NHLBI $668,250 total costs Platelet Inhibition with Crushed Ticagrelor versus Eptifibatide Bolus in Patients with Non-ST-Segment Elevation Myocardial Infarction undergoing Ad Hoc PCI with no Opiods R01HD108618 (Taub) 04/01/2022 – 03/31/2024 0.6 CM NIH/NCHHD $1,183,924 total costs A Therapy for Long COVID Brain Fog and Cognitive Impairment U24HL155807 (Aban) 07/01/2021 – 06/30/2027 0.6 CM NIH/NHLBI $1,844,073 total costs 2/2 Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD) R01AG070049 (Taub) 08/01/2021 – 07/31/2025 0.6 CM NIH/NCHHD $2,312,394 total costs Transferring Speed of Processing Gains to Everyday Cognitive Tasks after Stroke R01DK131079 (Novak) 12/01/2021 – 11/30/2026 1.2 CM NIH/NIDDK $3,764,635 total costs Unraveling Clinical and Pathophysiologic Disparities in African Americans with IgA Nephropathy) To address the historic lack of research into this chronic disease in African American patients, we will identify the first large, well-characterized, cohort of African American patients with IgA nephropathy and will assess factors associated with their disease pathogenesis, severity, and progression. Role: Co-Investigator K23DK131291 (Farrington) 09/01/2021 – 08/31/2026 no effort, consultant NIH/NIDDK $943,378 The Role of the Immune System in Arteriovenous Fistula Failure OSP 531819 (Agarwal) 06/01/2021 – 05/31/2025 0.6 CM NIH $2,830,956 Biological and Clinical Characterization of Kidney Patients Post-Acute Covid19 (BACKPAC) OTA-21-015B OSP 532702 (Aban) 02/01/2022 – 01/31/2028 0.6 CM NIH $281,882 Early Epilepsy Surgery in Tuberous Sclerosis Complex
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
The MG Registry receives funding from the Myasthenia Gravis Foundation of America
Stock/stock Options/board of Directors Compensation:
1.
Consortium of MS Centers - Past President - only expenses covered
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Ruth Ann Marrie, MD, PhD
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Multiple Sclerosis Journal, Editorial Board Multiple Sclerosis Journal-ETC, Co-Editor (ended Dec 2020)
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Roche (no direct funding to me), Biogen (no direct funding to me)
Research Support, Government Entities:
1.
Received support as principal investigator from the Canadian Institutes of Health Research (2010-2022), and Research Manitoba (2014-2022) and as co-investigator from US Department of Defense (2020-2023).
Research Support, Academic Entities:
1.
Waugh Family Chair in Multiple Sclerosis
Research Support, Foundations and Societies:
1.
Received support as principal investigator from Multiple Sclerosis Society of Canada (2009-2022) and the National Multiple Sclerosis Society (2013-2021), and as co-principal investigator from Multiple Sclerosis Scientific Foundation (2009-2021). Received support from Consortium of Multiple Sclerosis Centers (2004-2009, 2011-2014, 2016-2022), Crohn's and Colitis Canada (2014- 2022), The Arthritis Society (2021-2022)
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Kathryn Nichol, PhD
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
1) Currently employed at LivaNova since Oct 2021 2) Previously employed at Greenwich Biosciences (Jazz/GW) from June 2015 to Oct 2021 Stock/Stock Options, Medical Equipment & Materials: 1) Greenwich Biosciences, June 2015 to Oct 2021
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Joshua R. Steinerman, MD
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Greenwich Biosciences, Vice President, Neuropsychiatry, 2020- 2021
Consultancies:
1.
Click Therapeutics Stock/Stock Options, Medical Equipment & Materials: (1) Jazz Pharmaceuticals 2021, (2) GW Pharmaceuticals 2020- 2021, (3) Click Therapeutics 2020-2021
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Karry M.J. Smith, PhD, MPH
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Spouse has received reimbursement for travel related to consulting for Medtronic, Boston Scientific, Abbott (formerly St Jude), and Regenexx. Funds from each company amount to approximately less than $10K USD each.
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
Self, currently employed by Merck (US), managing medical writer, Sep 2021-present Self, formerly employed by GW Pharma/Jazz, senior manager medical writing, July 2019-Aug 2021 (directly related to this manuscript).
Consultancies:
1.
See consultancies for spouse listed above in Q3. Stock/Stock Options, Medical Equipment & Materials: The following were not sponsors of this research, but we do hold stock in these companies. Self - GW Pharma 2019-2021, Jazz Pharmaceuticals 2021-present, Merck (US) 2021-present
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
UT Southwestern Medical Center (AS), Dallas, TX; The University of Alabama at Birmingham (GC); Max Rady College of Medicine (RAM), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Greenwich Biosciences, Inc. (KN, JRS, KMJS), Carlsbad, CA; and Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH.
Disclosure
Scientific Advisory Boards:
1.
AB Science, Biogen, Genzyme, Immunic, Janssen, Novartis, and Sanofi
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Editorial Board, Neurology Editorial Board, Multiple Sclerosis Journal
Patents:
1.
NONE
Publishing Royalties:
1.
Multiple Sclerosis and Related Disorders, Demos Medical, 2019
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
AB Science, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Greenwich Biosciences, Immunic, Janssen, Novartis, Sanofi, and TG Therapeutics
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Research contracts from Biogen, Novartis, and Sanofi.
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE

Notes

Correspondence Dr. Salter [email protected]
Funding information and disclosures are provided at the end of the article. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp.
The Article Processing Charge was funded by Greenwich Biosciences, Inc.

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