national drug abuse treatment clinical trials network

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For ongoing studies, these reports are updated regularly (daily to monthly, depending on the report). Screening and assessment offer the promise of early detection of patients unhealthy substance use, prompting measures to prevent progression to a fully developed addiction. Subst Abuse Rehabil. Top, Copyright 2022 Dove Press Ltd In such a model, clinical study results generated in the health care system can lead directly to changes in clinical practice and improved patient care. Ghitza UE, Wu LT, Tai B. Thank you for your interest in working with Emmes. 2013;108:38. 2012;4:458470. (ASPE Issue Brief). Accessed January 21, 2014. US Department of Health and Human Services. Integrating substance abuse care with community diabetes care: implications for research and clinical practice. Tai B, Wu LT, Clark HW. There are several key research gaps that need to be addressed; existing clinical research programs, such as the National Drug Abuse Treatment Clinical Trials Network (CTN) at the National Institute on Drug Abuse (NIDA), can serve an important role in this endeavor. UK VAT Group: GB 365 4626 36. This framework allows the CTN to rapidly test and disseminate science-based treatments to communities nationwide. Improving drug abuse treatment delivery through adoption of harmonized electronic health record systems. EMMES supports NIDA as the Clinical Coordinating Center (CCC) providing resources to support the CTN in its general operations and the conduct of the multi-site clinical trials. J Health Care Poor Underserved. The Networks opioid portfolio currently includes five main categories of studies: (1) large multi-site studies; (2) studies aimed at closing the treatment gap; (3) expansion of ongoing studies to improve service delivery and implementation; (4) studies to explore the use of substance use data in electronic health record systems; (5) training and dissemination projects to expand the research/health care provider workforce. Thrombus aspiration during ST-segment elevation myocardial infarction. Javascript is currently disabled in your browser. With funding from the Helping to End Addiction Long-Term InitiativeSM(HEAL), the CTN established five new Nodes, which, along with the pre-existing Nodes, are distributed in every region of the nation and engage researchers and clinicians in areas that have been among the hardest hit by the opioid epidemic. On a monthly basis, the TPR is archived to allow review by study leadership. Washington, DC, USA: US Department of Health and Human Services; 2010. The evidence generated is then a natural outgrowth of the health care delivery process and leads to continual improvement in care.23, With the wide adoption of EHRs by health care providers, EHRs have the potential to become the primary vehicle for capturing clinical research data and are therefore a central element in the implementation of a learning health care system. Associations & Partners Review and recommendations from a NIDA Consensus Group. James L. Sorensen, PhD, Principal Investigator Director of the California-Arizona CTN Node Available from: http://www.pcori.org/funding-opportunities/pcornet-national-patient-centered-clinical-research-network/. High-priority research gaps are highlighted in this commentary. To address this problem, the National Institute on Drug Abuse (NIDA) has established the National Drug Abuse Treatment (NDAT) Clinical Trials Network (CTN). 2011;2:227233. Recommend this site Registered in England and Wales. Nat Neurosci. Together with the formation and expansion of practice-based research networks, the wide adoption of health information technologies in clinical practice offers an opportunity to integrate clinical trials into clinical care delivery systems.21 The CTN, and the field of SUD clinical research in general, should continue to explore every means of taking up this opportunity to develop resources and infrastructures to support cost-efficient, pragmatic SUD trials, with the aim of accelerating the translation of effective practices from research into clinical care.

The objective of the CTN is twofold: Participants with substance abuse enroll in behavioral, pharmacological, and integrated treatment intervention studies conducted at some of the 240 Community-based Treatment Programs (CTPs) associated with 16 regional nodes across the United States. Clin Trials. In some circumstances, SUD clinical researchers must take into account the special privacy provisions afforded to SUD patient records by Title 42, Part 2, of the US Code of Federal Regulations.15. Treatment for substance use disorder: opportunities and challenges under the affordable care act. This work is published and licensed by Dove Medical Press Limited. Bulk reprints for the pharmaceutical industry. Committee on Substance Abuse, Levy SJ, Kokotailo PK. Register your specific details and specific drugs of interest and we will match the information you provide to articles from our extensive database and email PDF copies to you promptly. In light of the accelerating integration of SUD care into the medical mainstream, and the consequent demand for research evidence to guide the delivery of SUD care in these contexts, the CTN must address the critical knowledge gaps outlined in the preceding sections of this commentary. Buck JA.

Digital Infrastructure for the Learning Health System The Foundation for Continuous Improvement in Health and Health Care Workshop Series Summary. The Data and Statistics Center (DSC) for the CTN has developed a website to support management and monitoring of trial progress and general CTN activities. Buntin MB, Jain SH, Blumenthal D. Health information technology: laying the infrastructure for national health reform. Institute of Medicine. By accessing the work you hereby accept the Terms. JAMA. Contact Us open access to scientific and medical research. We also retain data in relation to our visitors and registered users for internal purposes and for sharing information with our business partners. Tai, B., Dobbins, R., Blackeney, Q. et al. Washington, DC, USA: National Academies Press; 2013. The PCORnet, recently established by the US Patient-Centered Outcomes Research Institute, is a large, national network that supports clinical outcomes research efforts. 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Through PCORnet, the US Patient-Centered Outcomes Research Institute aims to foster a range of observational and experimental comparative effectiveness research endeavors by establishing a resource of clinical data gathered in real-time and in real-world settings.26 Collaborations between the CTN and established networks like PCORnet will allow for a synergy of resources and create opportunities for novel, pragmatic, and cost-effective SUD clinical research projects. 2005;8:14291430. Bhattacharya S, Dunham AA, Cornish MA, et al. 2012;43:1219. Select the most appropriate reason you are requesting follow-up from Emmes. To date, the efficacy of new treatments for drug addiction has been demonstrated primarily in specialized research settings, with somewhat restricted patient populations. mcleman bethany team Accessed April 14, 2014. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. 2003;290:16241632. Green LW. Ghitza UE, Sparenborg S, Tai B. In response to the opioid epidemic, a CTN task force generated a comprehensive list of research priorities in the areas of prevention, treatment, knowledge dissemination, and workforce training, to form the basis of the Networks opioid portfolio. Clinical quality measures to substantiate the research evidence and to facilitate policy development to promote the adoption of screening and assessment tools and treatment interventions in general medical settings. Web Design by Adhesion. 2013;369:15871597. There is a critical need to understand better how co-occurring conditions, such as major depression, diabetes, asthma, cancers, and cardiovascular disease, are related to the severity of SUD conditions and SUD treatment outcomes. Keywords: Patient Protection and Affordable Care Act, National Drug Abuse Treatment Clinical Trials Network, substance use disorders, practice-based research network, electronic health records, The Patient Protection and Affordable Care Act (2010) and other recent federal health care legislation are bringing about substantial changes in how the US health care system provides treatment for substance use disorders (SUD) to those who need it.1 Mental health and/or SUD services benefits are expanding to include approximately 32 million formerly uninsured people.2 The Patient Protection and Affordable Care Act promotes the integration of a wide array of medical services, including behavioral health care, into patient-centered medical homes, health maintenance organizations, or accountable care organizations, which are typically affiliated with local health departments and/or community health centers.3 The Mental Health Parity and Addiction Equity Act (2008) mandates group health plans and insurers to offer health care benefits for SUD treatment services that are comparable with coverage for general medical and surgical care.1,2 Consequently, many health plans are expected to offer SUD prevention, early intervention, and treatment services in integrated treatment systems.46 Taken together, these changes in the health care landscape are bringing SUD care into general medical settings and into better alignment with the management of other chronic illnesses.46, Another recently enacted piece of legislation, the Health Information Technology for Economic and Clinical Health Act (2009), is stimulating the adoption of electronic health record (EHR) systems and the meaningful use of fully certified health information technology.7 This legislative mandate has accelerated the development and implementation of interoperable EHR systems, which enable the free flow of patients health-related information among various medical practices and facilities and the provision of coordinated, patient-centered comprehensive care.810, In summary, recently enacted legislation is effecting profound changes in how, where, and to whom SUD care is delivered.17 The number of patients with unhealthy substance use behaviors or a SUD that can benefit from health care could increase more than ten-fold.2 The services available to them will expand from specialty SUD or mental health care facilities for treatment seekers to general medical settings. The unprecedented expansion of health care engagement and utilization by SUD patients calls for new research to guide evidence-based practices for SUD care in general medical settings. San Francisco, CA 94110 Addict Sci Clin Pract 16, 28 (2021). The National Drug Abuse Treatment Clinical Trials Network (CTN) is a means by which medical and specialty treatment providers, treatment researchers, participating patients, and the National Institute on Drug Abuse cooperatively develop, validate, refine, and deliver new treatment options to patients. Tunis SR, Stryer DB, Clancy CM. 2006;96:406409. These reports track the progress of each protocol within the CTN from the date of first randomization to final closeout and publication of main results. The goal of the CA-AZ Research Node is to stimulate research to improve the effectiveness of treatment of addiction to opiates, cocaine and methamphetamine, nicotine, and other abused drugs. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. saves opioid overdose Screening and assessment leading to appropriate and timely care may be of particular benefit to high-risk patient populations,10 including young adults and adolescents.12 For patients with co-occurring chronic conditions, identifying and addressing substance use problems may improve health care outcomes and quality of life.6,11,13 Research in this area can inform the reviews and practice recommendations of the US Preventive Services Task Force and, more generally, support health care providers adoption of effective screening, assessment, and treatment methods. 2012;7:16. The CTN infrastructure consists of the National Institute on Drug Abuse (NIDA), multiple Nodes each linked with several treatment sites representing the continuum of SUD care, a Clinical Coordinating Center, and Data and Statistical Center. 2013;4:310. While the CTN has undertaken research projects on SUD care in general medical settings in the USA,24 to this point the networks efforts have primarily been focused on treatment provided in specialty care settings. The opinions in this paper are those of the authors and do not represent the official position of the US government. The promise of producing readily generalizable research results is one key advantage; EHR data from general medical settings identify a comprehensive demographic spectrum of patients, including patients with complex real-world arrays of co-occurring conditions. US Department of Health and Human Services. You can learn about what data of yours we retain, how it is processed, who it is shared with and your right to have your data deleted by reading our Privacy Policy. Accessed April 14, 2014. Patient registry infrastructures may also be used as a platform for conducting clinical trials in SUDs, facilitating the accelerated recruitment of community residents into trials, streamlining of data collection and follow-up procedures, and evaluation of health status and health care utilization outcome measures.5,14 Trials that utilize registries in this way can achieve savings in both time and costs.18,19, Care for patients with multiple chronic co-occurring conditions. The mission of the CTN is to forge partnerships to improve the quality of drug abuse treatment nationwide. This unique partnership enables the following: Studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, multisite clinical trials to determine effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations; and. Soc Work Public Health. 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Share the Knowledge:ISSUP members can post in the Knowledge Share Sign in or become a member. Several features of One example of a practice-based research network is the PCORnet, the National Patient-Centered Clinical Research Network. Vaccine Trials And Infectious Diseases Research. SUD detection and patient engagement in general medical settings, Engaging primary care providers to undertake routine or targeted SUD screening and assessment of their patients is the first critical step in integrating SUD care into general medical settings. Washington, DC, USA: Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, 2013. Integrating information on substance use disorders into electronic health record systems. Recent US federal health care legislation, including the Patient Protection and Affordable Care Act, Mental Health Parity and Addiction Equity Act, and Health Information Technology for Economic and Clinical Health Act, is spurring transformative changes in the provision of SUD care.17 The expansion of health care insurance coverage and the augmentation of coverage mandates for SUD care are making treatment for SUDs and co-occurring conditions newly accessible to millions of patients and prompting the expansion of SUD screening, assessment, and treatment services into general medical settings.2,5 When the legislative vision is fully realized, patients presenting for primary care with multiple chronic co-occurring conditions, including SUDs, should expect to receive more integrated care, ideally coordinated within a chronic care or patient-centered medical home model.1,5,6 However, there is an urgent need for research evidence to guide the implementation of this new paradigm for SUD care. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Over the past two decades, the National Drug Abuse Treatment Clinical Trials Network (CTN), a program of the National Institute on Drug Abuse (NIDA), has expanded from the initial six Nodes to 16 Nodes, as a nationwide consortium of research scientists and treatment providers working together to improve care for substance use in the nations communities. 2010;29:12141219. Sci Transl Med. The TPR and DSR summarizes data over multiple protocols and provides detailed trial-specific information. Should be a properly formatted email address where you would like to be contacted. Pediatrics. With autism numbers rising, how best to provide support. The opinions expressed in all articles published here are those of the specific author(s), and do not necessarily reflect the views of Dove Medical Press Ltd or any of its employees. Thank you for visiting our site and taking an interest in our products & services. Tai B, McLellan AT. Available from: http://www.hhs.gov/ash/initiatives/mcc/mcc_framework.pdf. The measurement to understand reclassification of disease of Cabarrus/Kannapolis (MURDOCK) study community registry and repository. The NIDA clinical trials network: evolving, expanding, and addressing the opioid epidemic.

The very large number of patients that can be aggregated through EHRs will enable researchers to correlate genotypic data with clinical phenotypic data and accelerate big data analysis to inform personalized medical care. Am J Transl Res. Open access peer-reviewed scientific and medical journals.

Through this expanded network and its commitment to developing personalized, evidence-based treatments, the CTN is poised to address and provide solutions for the ongoing epidemic of opioid use and addiction. Testimonials 2014;46:541545. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms. 2014;25(Suppl 1):3645. PCORnet: The National Patient-Centered Clinical Research Network. Tenenbaum JD, Christian V, Cornish MA, et al. Please provide any additional information that may help us assist with your comments/request. https://doi.org/10.1186/s13722-021-00238-6, Copyright 2022 International Society of Substance Use Prevention and Treatment Professionals, The NIDA Clinical Trials Network: Evolving, Expanding, and Addressing the Opioid Epidemic, Basic Counselling Skills Mentoring Course, European Prevention Standards Partnership, Basic Counseling Skills Mentorship Course. Available from: http://aspe.hhs.gov/health/reports/2013/mental/rb_mental.cfm. To meet the challenge of filling the critical research gaps, the SUD clinical research community and, in particular, the NIDA CTN, should: expand clinical research infrastructures to include practice-based research networks in general medical settings; develop the learning health care system model for conducting practical trials30 and comparative effectiveness research;31 identify and evaluate feasible chronic care models for the treatment of SUDs and co-occurring conditions;11 and leverage modern health information technology, including EHRs, as new resources for data collection and data sharing.5,810,29 These foundational steps should help to ensure that new models for mainstreamed, integrated SUD care can be built upon a sturdy base of research evidence. Washington, DC, USA: National Academies Press; 2012. The looming expansion and transformation of public substance abuse treatment under the Affordable Care Act.

It has been well recognized that the randomized controlled trial is the gold standard for establishing evidence-based medical practices, but randomized controlled trials are often very costly, complex in design and execution, and slow to produce research results. Subst Abuse Rehabil. McLellan AT, Starrels JL, Tai B, et al. 2012;4:291301. This expansion should facilitate the adoption of chronic care models for the management of substance use problems and the integration of these services into the mainstream of the health care system.35,11, Research to guide expanded SUD care in general medical settings. First, there is a need to integrate SUD measurements into EHRs and to encourage the routine collection of key SUD data as part of usual care in general medical settings.9 With this objective in mind, NIDA, through the CTN, is striving to develop common data elements of SUD domains for both EHRs and SUD research.29 This initiative aims to establish a basis (eg, screening and assessment items for substance use) for SUD care to be integrated into primary care practice and to facilitate the use of new EHR-based data resources in clinical research.29, Patient privacy protections are also of critical importance for any research endeavor that seeks to use data drawn from clinical sources. Public health asks of systems science: to advance our evidence-based practice, can you help us get more practice-based evidence? The content includes areas from all aspects of the clinical trials including enrollment, retention, QA and regulatory. Select the most appropriate location of Emmes. Can substance use disorders be managed using the chronic care model? 2011;8:183195. NIDAs CTN is built upon collaboration between clinical researchers and treatment providers, and since its inception, the network has sought to design and conduct research that can directly inform SUD treatment practice. Fiore LD, Brophy M, Ferguson RE, et al. This information is essential to the task of devising effective chronic care algorithms to prevent drug use relapse, promote recovery, and maintain good health behaviors. 2013;28:165174. This expansion of SUD services presents a great need for evidence-based practices useful in general medical settings, and reveals several research gaps to be addressed. It is estimated that one in four Americans, and more than half of those who are 65 years of age and older, suffer from more than one chronic medical condition.20,21 For many, one of these conditions is a SUD. Care offered in these settings will engage substance-using patients in an integrated and patient-centered environment that addresses physical and mental health comorbidities and follows a chronic care model. 2011;2:125131. J Subst Abuse Treat. Am J Transl Res. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Challenges and opportunities for integrating preventive substance-use-care services in primary care through the Affordable Care Act. If you need access, please complete the staff form, or contact the NIDA DSC help desk by either sending an email to nidadsc2help@emmes.com or by calling (888) 337-7071. You can learn about our use of cookies by reading our Privacy Policy. Health Aff (Millwood). In order to provide our website visitors and registered users with a service tailored to their individual preferences we use cookies to analyse visitor traffic and personalise content. The major responsibilities include: Providing protocol development and implementation support, Conducting quality assurance monitoring visits, Training CTN members associated with various nodes and protocols, Managing pharmaceutical and laboratory services and supply logistics. N Engl J Med. The gap between research and treatment is one of the most critical unresolved issues in drug abuse. Washington, DC, USA: National Academies Press; 2011. http://aspe.hhs.gov/health/reports/2013/mental/rb_mental.cfm, http://www.healthcare.gov/law/full/index.html, http://www.hhs.gov/ash/initiatives/mcc/mcc_framework.pdf, http://www.pcori.org/funding-opportunities/pcornet-national-patient-centered-clinical-research-network/, Creative Commons Attribution - Non Commercial (unported, v3.0) License, Validated, brief, and actionable SUD screening and assessment tools that are suitable for efficient and user-friendly administration in general medical settings, Evidence-based brief interventions for SUDs that can be efficiently integrated into the busy workflows of primary care settings and tailored to match the level of risk identified through the brief assessment tools, Evidence-based, sustainable, and scalable implementation methods to engage and train primary care providers to adopt effective screening and assessment tools and interventions in their practices, Practical approaches to effectively build linkage and referral techniques between primary care and SUD specialty care and leverage mobile technologies and telemedicine to enhance the reach of these techniques, Outcome measures, such as rates of hospital readmission and emergency department visits or measures of improvement or progression of co-occurring illnesses, that may be of particular relevance for patients and providers in general medical settings. marijuana pregnancy baby use during harm thinkstock creatas