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Side effects of medications for opioid use disorder (MOUD) such as weight gain contribute to their stigma. Substantial evidence suggests that women have a more severe side effect profile to MOUD than men, and concerns about weight gain during treatment are prevalent. However, the few studies reporting sex differences in weight gain during treatment show conflicting results and are restricted to methadone. In addition, little is known about possible sex differences in weight gain to buprenorphine, which is the most commonly prescribed MOUD in the United States.To address these issues, we performed a systematic review and meta-analysis on the few studies reporting longitudinal data on sex differences in body mass index (BMI) gain during methadone treatment (Study 1). In a separate study, we also re-analyzed data from trial CTN-0030 of the National Institute on Drug Abuse Clinical Trial Network (NIDA CTN), which involved a 12-week buprenorphine treatment regimen (Study 2; n = 360; 209 Male, 151 Female).For Study 1, across all papers reporting longitudinal data (k = 4, n = 362 OUD patients), there were BMI increases that ranged from 2.2 to 5.4 BMI after at least one year of methadone treatment, but there were no significant sex differences in BMI increases (Standardized Mean Difference, FemaleMale = 0.352, SE =0.270; 95 % CI = [-0.18 0.88]; p = .193). Study 2 showed no significant differences in weight before and after 12 weeks of buprenorphine treatment nor did it show sex differences in weight change with treatment (β = 2.34, p = .511).These analyses corroborate evidence of weight gain with methadone treatment but did not observe a sex-based disparity in weight gain with methadone or buprenorphine treatment for OUD.

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 nation’s communities. Encompassing both specialty care programs and general medical settings, the Network has become a unique resource for expertise on clinically focused research, bridging the gap between research and treatment delivery. Over 22 years, the CTN has completed 101 studies, resulting in 650 publications. 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 Network’s opioid portfolio. The Network’s 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. 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. 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.

Context and PurposeMeasurement‐based care (MBC) is an evidence‐based health‐care practice in which indicators of disease are tracked to inform clinical actions, provide feedback to patients and improve outcomes. The current opioid crisis in multiple countries provides a pressing rationale for adopting a basic MBC approach for opioid use disorder (OUD) using DSM‐5 to increase treatment retention and effectiveness.ProposalTo stimulate debate, we propose a basic MBC approach using the 11 symptoms of OUD (DSM‐5) to inform the delivery of medications for opioid use disorder (MOUD; including methadone, buprenorphine and naltrexone) and their evaluation in office‐based primary care and specialist clinics. Key features of a basic MBC approach for OUD using DSM‐5 are described, with an illustration of how clinical actions are guided and outcomes communicated. For core treatment tasks, we propose that craving and drug use response to MOUD should be assessed after 2 weeks, and OUD remission status should be evaluated at 3, 6 and 12 months (and exit from MOUD treatment) and beyond. Each of the 11 DSM‐5 symptoms of OUD should be discussed with the patient to develop a case formulation and guide selection of adjunctive psychological interventions, supplemented with information on substance use, and optionally extended with information from other clinical instruments. A patient‐reported outcome measure should be recorded and discussed at each remission assessment.ConclusionsMBC can be used to tailor and adapt MOUD treatment to increase engagement, retention and effectiveness. MBC practice principles can help promote patient‐centred care in OUD, personalized addiction therapeutics and facilitate communication of outcomes.

Aim To investigate associations between substance dependence and obesity. Methods Obesity (body mass index ≥ 30 kg/m2) status and the status of dependence on heroin, stimulant, marijuana, nicotine and alcohol (past-month status for nicotine and past-year status for all others) were identified from the U.S. National Survey on Drug Use and Health (NSDUH, 2015–2017) datasets. SAS Surveylogistic regression was used to estimate adjusted odds ratio (AOR) for the association between each substance dependence and obesity, adjusting for potentially confounding effects of sociodemographic factors and health condition. Results It was estimated that 10.6 % of noninstitutional U.S. residents aged 12 years or older were nicotine-dependent, 3.0 % alcohol-dependent, 1.0 % marijuana-dependent, 0.6 % stimulant-dependent, and 0.2 % heroin-dependent. Heroin-dependent individuals had 59 % lower odds of obesity relative to their non-dependent counterparts (AOR = 0.41; 95 % CI: 0.28−0.60; p Conclusions Heroin, marijuana, nicotine and alcohol dependence were associated with lower odds of obesity than their non-dependence counterparts. Main findings based on 2015–2017 NSDUH are consistent with findings from our prior report based on clinical trials data from National Institute on Drug Abuse Clinical Trials Network, and other epidemiological evidence in the literature. These findings can alert substance abuse treatment professionals to monitor weight change, especially among weight-concerned substance abusers.

Hodgkin lymphoma (HL) is a lymphoid malignancy that is typically derived from germinal-center B cells. EBV infection, mutations in NF-κB pathway genes, and genetic susceptibility are known risk factors for developing HL. CD30 and NF-κB have been identified as potential biomarkers in pediatric HL patients, and these molecules may represent therapeutic targets. Although current risk adapted and response based treatment approaches yield overall survival rates of >95%, treatment of relapse or refractory patients remains challenging. Targeted HL therapy with the antibody-drug conjugate Brentuximab vedotin (Bv) has proven to be superior to conventional salvage chemotherapy and clinical trials are being conducted to incorporate Bv into frontline therapy that substitutes Bv for alkylating agents to minimize secondary malignancies. The appearance of secondary malignancies has been a concern in pediatric HL, as these patients are at highest risk among all childhood cancer survivors. The risk of developing secondary leukemia following childhood HL treatment is 10.4 to 174.8 times greater than the risk in the general pediatric population and the prognosis is significantly poorer than the other hematological malignancies with a mortality rate of nearly 100%. Therefore, identifying clinically valuable biomarkers is of utmost importance to stratify and select patients who may or may not need intensive regimens to maintain optimal balance between maximal survival rates and averting late effects. Here we discuss epidemiology, risk factors, staging, molecular and genetic prognostic biomarkers, treatment for low and high-risk patients, and the late occurrence of secondary malignancies in pediatric HL.

Emergency clinicians are on the front lines of responding to the opioid epidemic and are leading innovations to reduce opioid overdose deaths through safer prescribing, harm reduction, and improved linkage to outpatient treatment. Currently, there are no nationally recognized quality measures or best practices to guide emergency department quality improvement efforts, implementation science researchers, or policymakers seeking to reduce opioid-associated morbidity and mortality. To address this gap, in May 2017, the National Institute on Drug Abuse's Center for the Clinical Trials Network convened experts in quality measurement from the American College of Emergency Physicians' (ACEP's) Clinical Emergency Data Registry, researchers in emergency and addiction medicine, and representatives from federal agencies, including the National Institute on Drug Abuse and the Centers for Medicare & Medicaid Services. Drawing from discussions at this meeting and with experts in opioid use disorder treatment and quality measure development, we developed a multistakeholder quality improvement framework with specific structural, process, and outcome measures to guide an emergency medicine agenda for opioid use disorder policy, research, and clinical quality improvement.

To estimate obesity prevalence among drug-dependent individuals and to compare prevalence across different types of drug dependence.1596 opioid- and/or stimulant-dependent participants were extracted from six clinical trials within the National Drug Abuse Treatment Clinical Trials Network of the National Institute on Drug Abuse (NIDA CTN) to estimate obesity prevalence among drug-dependent users. Age-, sex-, and race-matched National Health and Nutrition Examination Survey (NHANES) samples were used as a general population reference. Standardized prevalence ratios (SPRs) were calculated to compare the CTN sample to NHANES as well as to compare within the CTN sample. Logistic regression estimated associations between the type of drug dependence and obesity.The standardized obesity prevalence among the drug-dependent CTN trial participants was 67% of expected for age-, sex- and race-matched NIHANES participants (SPR = 0.67, 95% CI: 0.60-0.74). Obesity was least prevalent among opioid-dependent-only participants (SPR = 0.36, 95% CI: 0.27-0.46 compared to the NHANES, and SPR = 0.33, 95% CI: 0.23-0.46 compared to the stimulant-dependent-only participants). Compared to stimulant-dependent-only users (p 0.0001), the odds of obesity were 67% lower among opioid-dependent-only users (adjusted odds ratio [AOR] = 0.33, 95% CI: 0.23-0.46) and 33% lower among opioid and stimulant-co-dependent users (AOR = 0.67, 95%CI: 0.49-0.90) after controlling for age, sex, race, education and employment pattern.The prevalence of obesity among drug-dependent clinical trial participants was lower than the general population, and lowest among opioid-dependent-only users, suggesting an inverse relationship between obesity prevalence and drug dependence, most notable among opioid-dependent-only users.

Syndecan-1 (SDC1, CD138) is a key cell surface adhesion molecule essential for maintaining cell morphology and interaction with the surrounding microenvironment. Deregulation of SDC1 contributes to cancer progression by promoting cell proliferation, metastasis, invasion and angiogenesis, and is associated with relapse through chemoresistance. SDC1 expression level is also associated with responses to chemotherapy and with prognosis in multiple solid and hematological cancers, including multiple myeloma and Hodgkin lymphoma. At the tissue level, the expression levels of SDC1 and the released extracellular domain of SDC1 correlate with tumor malignancy, phenotype, and metastatic potential for both solid and hematological tumors in a tissue-specific manner. The SDC1 expression profile varies among cancer types, but the differential expression signatures between normal and cancer cells in epithelial and stromal compartments are directly associated with aggressiveness of tumors and patient's clinical outcome and survival. Therefore, relevant biomarkers of SDC signaling may be useful for selecting patients that would most likely respond to a particular therapy at the time of diagnosis or perhaps for predicting relapse. In addition, the reciprocal expression signature of SDC between tumor epithelial and stromal compartments may have synergistic value for patient selection and the prediction of clinical outcome.

Undertreated or untreated substance use disorders (SUD) remain a pervasive, medically-harmful public health problem in the United States, particularly in medically underserved and low-income populations lacking access to appropriate treatment. The need for greater access to SUD treatment was expressed as policy in the Final Rule on standards related to essential health benefits, required to be covered through the 2010 Affordable Care Act (ACA) health insurance exchanges. SUD treatment services have been included as an essential health benefit, in a manner that complies with the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008. Consequently, with the ACA, a vast expansion of SUD-care services in primary care is looming. This commentary discusses challenges and opportunities under the ACA for equipping health care professionals with appropriate workforce training, infrastructure, and resources to support and guide science-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for SUD in primary care.

To build capacity and collaborative research for future cross-national studies in the Asian and Pacific Islander (API) region, priority research topics were identified and discussed at the April 2013 Conference to Promote Global Health in Taipei. These topics included: (1) neuroscience on human immunodeficiency virus (HIV)/hepatitis C virus (HCV) and amphetamine-type stimulants (ATS), led by Drs Linda Chang, Gene-Jack Wang, and Betty Tai; (2) ATS and mental health disorders, led by Drs Richard Rawson and Wilson Compton; and (3) HIV/HCV transmission and social networks, led by Drs Steven Shoptaw and Jacques Normand. Potential genetic studies spanning these topical areas as well as the importance of smoking cessation were further discussed, led by Dr Ming Li. Additional priority research topics were also identified: (4) drug use prevention; and (5) family involvement to improve treatment adherence and recovery. Workgroups on these topics will be formed to prioritize research questions within the respective topical area and to determine the next steps. The ultimate goal of these workgroups is to stimulate collaboration that will eventually lead to research studies addressing critical issues related to the rising substance abuse and HIV infection rates in many Asian countries and, at the same time, to advance the scientific knowledge of substance abuse and HIV infection.

Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN's primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.

Aims Electronic health records (EHRs) are essential in improving quality and enhancing efficiency of health-care delivery. By 2015, medical care receiving service reimbursement from US Centers for Medicare and Medicaid Services (CMS) must show ‘meaningful use’ of EHRs. Substance use disorders (SUD) are grossly under-detected and under-treated in current US medical care settings. Hence, an urgent need exists for improved identification of and clinical intervention for SUD in medical settings. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUD in general medical settings, with the objective of incorporation into US EHRs. Methods Stakeholders were identified and queried for input and consensus on validated screening and assessment for SUD in general medical settings to develop common data elements to serve as shared resources for EHRs on screening, brief intervention and referral to treatment (SBIRT), with the intent of supporting interoperability and data exchange in a developing Nationwide Health Information Network. Results Through consensus of input from stakeholders, a validated screening and brief assessment instrument, supported by Clinical Decision Support tools, was chosen to be used at out-patient general medical settings. Conclusions The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and ‘meaningful use’ of the US Office of the National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement.

Betty Tai1, Li-Tzy Wu2, H Westley Clark31Center for Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, 2Department of Psychiatry and Behavioral Sciences, School of Medicine, Duke University Medical Center, Durham, NC, 3Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, Rockville, MD, USAAbstract: While substance use problems are considered to be common in medical settings, they are not systematically assessed and diagnosed for treatment management. Research data suggest that the majority of individuals with a substance use disorder either do not use treatment or delay treatment-seeking for over a decade. The separation of substance abuse services from mainstream medical care and a lack of preventive services for substance abuse in primary care can contribute to under-detection of substance use problems. When fully enacted in 2014, the Patient Protection and Affordable Care Act 2010 will address these barriers by supporting preventive services for substance abuse (screening, counseling) and integration of substance abuse care with primary care. One key factor that can help to achieve this goal is to incorporate the standardized screeners or common data elements for substance use and related disorders into the electronic health records (EHR) system in the health care setting. Incentives for care providers to adopt an EHR system for meaningful use are part of the Health Information Technology for Economic and Clinical Health Act 2009. This commentary focuses on recent evidence about routine screening and intervention for alcohol/drug use and related disorders in primary care. Federal efforts in developing common data elements for use as screeners for substance use and related disorders are described. A pressing need for empirical data on screening, brief intervention, and referral to treatment (SBIRT) for drug-related disorders to inform SBIRT and related EHR efforts is highlighted.Keywords: electronic health records, Patient Protection and Affordable Care Act 2010, primary care, screening, brief intervention, substance abuse treatment, substance use disorders

How do addiction treatment programs integrate the expectation of relapse into drug abuse treatment? This article serves as a thought piece to pose questions rather than definitive solutions. It reflects a distillation of discussions that occurred at the National Institute on Drug Abuse meeting titled "Program Response to Patient Relapse," held on July 15, 2009, along with quantitative and qualitative information about the patterns and types of discharge policies, which factors influence them, and how the culture of drug abuse treatment and the personnel interact with this issue. Some existing data on the discharging of relapsed patients are identified. A program's response to relapse is usually guided by its setting (level of care), philosophy (abstinence vs risk behavior reduction), and associated patient behavior ("benign" vs program disruptive). Key questions examined in this context include the following: Can different discharge policies impact a patient's access to treatment, and what are the implications of incorporating a medical model of addiction into discharge policies?

Although DSM-IV criteria are widely used in making diagnoses of substance use disorders, gaps exist regarding diagnosis classification, use of dependence criteria, and effects of measurement bias on diagnosis assessment. We examined the construct and measurement equivalence of diagnostic criteria for cocaine and opioid dependences, including whether each criterion maps onto the dependence construct, how well each criterion performs, how much information each contributes to a diagnosis, and whether symptom-endorsing is equivalent between demographic groups.Item response theory (IRT) and multiple indicators-multiple causes (MIMIC) modeling were performed on a sample of stimulant-using methadone maintenance patients enrolled in a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN) (N=383). Participants were recruited from six community-based methadone maintenance treatment programs associated with the CTN and major U.S. providers. Cocaine and opioid dependences were assessed by DSM-IV Checklist.IRT modeling showed that symptoms of cocaine and opioid dependences, respectively, were arrayed along a continuum of severity. All symptoms had moderate to high discrimination in distinguishing drug users between severity levels. "Withdrawal" identified the most severe symptom of the cocaine dependence continuum. MIMIC modeling revealed some support for measurement equivalence.Study results suggest that self-reported symptoms of cocaine and opioid dependences and their underlying constructs can be measured appropriately among treatment-seeking polysubstance users.

The aim of this study was to examine psychometric properties of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnostics criteria for alcohol and marijuana dependences among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network.Diagnostic questions were assessed by the DSM-IV checklist. Data were analyzed by the item response theory and the multiple indicators-multiple causes method procedures.Criterion symptoms of alcohol and marijuana dependences exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, "withdrawal" appeared to measure the most severe symptom of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level.These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana dependence syndromes among treatment-seeking substance users.

// Mohamed R. Akl 1 , Poonam Nagpal 1 , Nehad M. Ayoub 2 , Betty Tai 1 , Sathyen A. Prabhu 1 , Catherine M. Capac 1 , Matthew Gliksman 1 , Andre Goy 3 and K. Stephen Suh 1 1 Genomics and Biomarkers Program, The John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA 2 Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan 3 Lymphoma Division, The John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA Correspondence to: K. Stephen Suh, email: // Keywords : bFGF, FGF2, diagnosis, prognosis, malignancy, Received : October 20, 2015 Accepted : March 10, 2016 Published : March 19, 2016 Abstract Fibroblast growth factor (FGF) signaling is essential for normal and cancer biology. Mammalian FGF family members participate in multiple signaling pathways by binding to heparan sulfate and FGF receptors (FGFR) with varying affinities. FGF2 is the prototype member of the FGF family and interacts with its receptor to mediate receptor dimerization, phosphorylation, and activation of signaling pathways, such as Ras-MAPK and PI3K pathways. Excessive mitogenic signaling through the FGF/FGFR axis may induce carcinogenic effects by promoting cancer progression and increasing the angiogenic potential, which can lead to metastatic tumor phenotypes. Dysregulated FGF/FGFR signaling is associated with aggressive cancer phenotypes, enhanced chemotherapy resistance and poor clinical outcomes. In vitro experimental settings have indicated that extracellular FGF2 affects proliferation, drug sensitivity, and apoptosis of cancer cells. Therapeutically targeting FGF2 and FGFR has been extensively assessed in multiple preclinical studies and numerous drugs and treatment options have been tested in clinical trials. Diagnostic assays are used to quantify FGF2, FGFRs, and downstream signaling molecules to better select a target patient population for higher efficacy of cancer therapies. This review focuses on the prognostic significance of FGF2 in cancer with emphasis on therapeutic intervention strategies for solid and hematological malignancies.

The Clinical Trials Network (CTN) of the National Institute on Drug Abuse (NIDA) recently launched a public portal (http://cde.drugabuse.gov) (1), which provides a single-source repository for CTN-recommended common data elements (CDEs) for substance use disorders (SUD) for use in electronic health record systems (EHRs) and clinical research (1, 2). A CDE in this context is a data element consisting of a question and enumerated set of possible values for responses precisely defined by standardized metadata descriptors (1). CDEs consisting of individual question/answer pairs can be combined into more complex questionnaires and case report forms or used when gathering medical information in the context of providing clinical care (1). Thus, CDEs describe semantic characteristics for a discrete piece of data, which will be collected, stored, or exchanged during the course of a study or health examination. This will facilitate exchange of standardized data because of the use of CDEs (1). In this manner, NIDA CDEs can be commonly applied to multiple data collection systems whether in research or clinical care and across different institutions, such that their intentional commonality with use of common data standards can improve data quality, facilitate data re-purposing, and promote data sharing (1, 2). This paper describes objectives and importance of the CTN CDEs initiative and portal to translational psychiatric research: To support harmonized use of EHR-compatible common data elements to enable exchange and integration of data to answer clinically meaningful questions of broad interest to SUD treatment research, thereby facilitating big-data biomedical science crossing boundaries between research and clinical care.

This special issue documents the first meeting of the biennial Conference Series to Promote Global Health, which was held April 17–19, 2013, in Taipei, Taiwan. The conference series is sponsored by the National Institute on Drug Abuse of the U.S. National Institutes of Health, and the first meeting was organized by the UCLA Center for Advancing Longitudinal Drug Abuse Research (CALDAR), the Taiwan National Health Research Institute (NHRI), and the Taiwan Food and Drug Administration (TFDA). The theme of the first conference was prevention and treatment of substance abuse and HIV, focusing on Asia and the Pacific Islands (API). Articles in this special issue are organized into three sections. Section 1 consists of nine articles providing highlights from selected conference sessions. Section 2 includes five articles describing the current status of drug abuse and HIV in five Asian countries (China, Japan, Malaysia, Taiwan, and Vietnam) reported by their representatives. Section 3 has 15 articles, with the first 14 based on individual presentations at the conference. The final article summarizes priority research topics generated by workgroups that will form the basis for planning future international collaborative research on prevention and treatment of substance use and HIV, in order to promote health in API and other populations. Drug use persists as a major problem that severely impacts the health of individuals and populations, both locally and globally. The international Conference Series to Promote Global Health is designed to promote the sharing of research findings on substance abuse treatment and HIV prevention, stimulate international collaborations, particularly between the United States and API countries, and inform cultural aspects of the treatment and prevention of substance abuse and HIV. These and upcoming activities are part of efforts to promulgate research-based interventions to improve health services and promote health globally.

Betty Tai,1 Lian Hu,2 Udi E Ghitza,1 Steven Sparenborg,1 Paul VanVeldhuisen,2 Robert Lindblad2 1Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA; 2The EMMES Corporation, Rockville, MD, USA Abstract: This commentary discusses the need for developing patient registries of substance use disorders (SUD) in general medical settings. A patient registry is a tool that documents the natural history of target diseases. Clinicians and researchers use registries to monitor patient comorbidities, care procedures and processes, and treatment effectiveness for the purpose of improving care quality. Enactments of the Affordable Care Act 2010 and the Mental Health Parity and Addiction Equity Act 2008 open opportunities for many substance users to receive treatment services in general medical settings. An increased number of patients with a wide spectrum of SUD will initially receive services with a chronic disease management approach in primary care. The establishment of computer-based SUD patient registries can be assisted by wide adoption of electronic health record systems. The linkage of SUD patient registries with electronic health record systems can facilitate the advancement of SUD treatment research efforts and improve patient care. Keywords: substance use disorders, primary care, registry, electronic health records, chronic care model

Betty Tai, Steven Sparenborg, Udi E Ghitza, David Liu Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland, USA Abstract: The Patient Protection and Affordable Care Act (2010) and the Mental Health Parity and Addiction Equity Act (2008) expand substance use disorder (SUD) care services in the USA into general medical settings. 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. 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. The National Drug Abuse Treatment Clinical Trials Network of the National Institute on Drug Abuse can serve an important role in this endeavor. High-priority research gaps are highlighted in this commentary. A discussion follows on how the National Drug Abuse Treatment Clinical Trials Network can transform to address changing patterns in SUD care to efficiently generate evidence to guide SUD treatment practice within the context of recent US health care legislation. 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 “Medication-Assisted Therapy for Opioid Addiction” session was chaired by Dr Betty Tai and had three presenters. The presenters (and their topics) were: Dr Andrew J. Saxon (methadone and buprenorphine for treatment of opioid addiction and human immunodeficiency virus risk reduction); Dr Walter Ling (opioid antagonist treatment for opioid addiction); and Dr Betty Tai (chronic care model for substance use disorder).

Addiction is a chronic brain disease with consequences that remain problematic years after discontinuation of use. Despite this, treatment models focus on acute interventions and are carved out from the main health care system. The Patient Protection and Affordable Care Act (2010) brings the opportunity to change the way substance use disorder (SUD) is treated in the United States. The treatment of SUD must adapt to a chronic care model offered in an integrated care system that screens for at-risk patients and includes services needed to prevent relapses. The partnering of the health care system with substance abuse treatment programs could dramatically expand the benefits of prevention and treatment of SUD. Expanding roles of health information technology and nonphysician workforces, such as social workers, are essential to the success of a chronic care model.

In August 2011, scientists and policy-makers held a conference entitled “Using IT to Improve Community Health: How Health Care Reform Supports Innovation.” One of the conference sessions was entitled “Electronic health records: Meaningful use implementation challenges, innovation, and regulations.” This Meeting Report discusses the meaningful use of behavioral health data for the treatment of mental health and substance abuse conditions and optimization of behavioral wellness by primary care physicians.

For reasons of safety and effectiveness, many forces in health care, especially the Affordable Care Act of 2010, are pressing for improved identification and management of substance use disorders within mainstream health care. Thus, standard information about patient substance use will have to be collected and used by providers within electronic health record systems (EHRS). Although there are many important technical, legal, and patient confidentiality issues that must be dealt with to achieve integration, this article focuses upon efforts by the National Institute on Drug Abuse and other federal agencies to develop a common set of core questions to screen, diagnose, and initiate treatment for substance use disorders as part of national EHRS. This article discusses the background and rationale for these efforts and presents the work to date to identify the questions and to promote information sharing among health care providers.

The National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999 to improve the quality of addiction treatment using science as the vehicle. The network brings providers from community-based drug abuse treatment programs and scientists from university-based research centers together in an alliance that fosters bidirectional communication and collaboration. Collaboration enhanced the relevance of research to practice and facilitated the development and implementation of evidence-based treatments in community practice settings. The CTN's 20 completed trials tested pharmacological, behavioral, and integrated treatment interventions for adolescents and adults; more than 11,000 individuals participated in the trials. This article reviews the rationale for the CTN, describes the translation of its guiding principles into research endeavors, and anticipates the future evolution of clinical research within the Network.

Study objective In 2003, the Institute of Medicine Committee on the Future of Emergency Care in the United States Health System convened and identified a crisis in emergency care in the United States, including a need to enhance the research base for emergency care. As a result, the National Institutes of Health (NIH) formed an NIH Task Force on Research in Emergency Medicine to enhance NIH support for emergency care research. Members of the NIH Task Force and academic leaders in emergency care participated in 3 roundtable discussions to prioritize current opportunities for enhancing and conducting emergency care research. The objectives of these discussions were to identify key research questions essential to advancing the scientific underpinnings of emergency care and to discuss the barriers and best means to advance research by exploring the role of research networks and collaboration between the NIH and the emergency care community. Methods The Medical-Surgical Research Roundtable was convened on April 30 to May 1, 2009. Before the roundtable, the emergency care domains to be discussed were selected and experts in each of the fields were invited to participate in the roundtable. Domain experts were asked to identify research priorities and challenges and separate them into mechanistic, translational, and clinical categories. After the conference, the lists were circulated among the participants and revised to reach a consensus. Results Emergency care research is characterized by focus on the timing, sequence, and time sensitivity of disease processes and treatment effects. Rapidly identifying the phenotype and genotype of patients manifesting a specific disease process and the mechanistic reasons for heterogeneity in outcome are important challenges in emergency care research. Other research priorities include the need to elucidate the timing, sequence, and duration of causal molecular and cellular events involved in time-critical illnesses and injuries, and the development of treatments capable of halting or reversing them; the need for novel animal models; and the need to understand why there are regional differences in outcome for the same disease processes. Important barriers to emergency care research include a limited number of trained investigators and experienced mentors, limited research infrastructure and support, and regulatory hurdles. The science of emergency care may be advanced by facilitating the following: (1) training emergency care investigators with research training programs; (2) developing emergency care clinical research networks; (3) integrating emergency care research into Clinical and Translational Science Awards; (4) developing emergency care–specific initiatives within the existing structure of NIH institutes and centers; (5) involving emergency specialists in grant review and research advisory processes; (6) supporting learn-phase or small, clinical trials; and (7) performing research to address ethical and regulatory issues. Conclusion Enhancing the research base supporting the care of medical and surgical emergencies will require progress in specific mechanistic, translational, and clinical domains; effective collaboration of academic investigators across traditional clinical and scientific boundaries; federal support of research in high-priority areas; and overcoming limitations in available infrastructure, research training, and access to patient populations.

The National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999 to bring researchers and treatment providers together to develop a clinically relevant research agenda. Initial CTN efforts addressed the use of buprenorphine, a mu-opioid partial agonist, as treatment for opioid dependence. Strong evidence of buprenorphine's therapeutic efficacy was demonstrated in clinical trials involving several thousand opioid-dependent participants, and in 2002, the Food and Drug Administration approved buprenorphine for the treatment of opioid dependence. With the advent of a sublingual tablet containing both buprenorphine and naloxone to mitigate abuse and diversion (Suboxone), buprenorphine appeared poised to be the first-line treatment for opioid addiction. Notwithstanding its many attributes, certain implementation barriers remained to be addressed in CTN studies, and these efforts have brought a body of knowledge on buprenorphine to frontline clinicians. The purpose of this article is to review CTN-based buprenorphine research and related efforts to overcome challenges to the implementation of buprenorphine therapy in mainstream practice. Furthermore, this article explores current issues and future challenges that may require additional CTN efforts.

Background Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research. Purpose In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. We describe the centralized informatics infrastructure and discuss our challenges to inform others considering such an endeavor. Methods During the migration of a clinical trial network from a decentralized to a centralized data center model, descriptive data were captured and are presented here to assess the impact of centralization. Results We present the framework for the informatics infrastructure and evaluative metrics. The network has decreased the time from last patient-last visit to database lock from an average of 7.6 months to 2.8 months. The average database error rate decreased from 0.8% to 0.2%, with a corresponding decrease in the interquartile range from 0.04%—1.0% before centralization to 0.01—0.27% after centralization. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial. Limitations A single clinical trial network comprising addiction researchers and community treatment programs was assessed. The findings may not be applicable to other research settings. Conclusions The identified informatics components provide the information and infrastructure needed for our clinical trial network. Post centralization data management operations are more efficient and less costly, with higher data quality. Clinical Trials 2009; 6: 67—75. http://ctj.sagepub.com

Udi E Ghitza,1 Li-Tzy Wu,2 Betty Tai11Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, United States Department of Health and Human Services, Bethesda, MD, 2Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USAAbstract: Cigarette smoking and alcohol use are prevalent among individuals with diabetes in the US, but little is known about screening and treatment for substance use disorders in the diabetic population. This commentary discusses the scope and clinical implications of the public health problem of coexisting substance use and diabetes, including suggestions for future research. Diabetes is the seventh leading cause of death in the US, and is associated with many severe health complications like cardiovascular disease, stroke, kidney damage, and limb amputations. There are an estimated 24 million adults in the US with type 2 diabetes. Approximately 20% of adults aged 18 years or older with diabetes report current cigarette smoking. The prevalence of current alcohol use in the diabetic population is estimated to be around 50%–60% in epidemiological surveys and treatment-seeking populations. Cigarette smoking is associated with an increased risk of type 2 diabetes in a dose-dependent manner and is an independent modifiable risk factor for development of type 2 diabetes. Diabetic patients with an alcohol or other drug use disorder show a higher rate of adverse health outcomes. For example, these patients experience more frequent and severe health complications as well as an increased risk of hospitalization, and require longer hospital stays. They are also less likely to seek routine care for diabetes or adhere to diabetes treatment than those without an alcohol or other drug use disorder. The Affordable Care Act of 2010 and the Mental Health Parity Act and Addiction Equity Act of 2008 provide opportunities for facilitating integration of preventive services and evidence-based treatments for substance use disorders with diabetes care in community-based medical settings. These laws also offer emerging areas for research.Keywords: addiction, illicit drug use, substance use disorder, substance abuse treatment, alcohol use, diabetes care, primary care, screening, brief intervention

Lianne Lian Hu1, Steven Sparenborg2, Betty Tai21Department of Preventive Medicine and Biometrics, Uniformed Services University of the Health Sciences, 2Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MDAbstract: Many Americans with substance use problems will have opportunities to receive coordinated health care through the integration of primary care and specialty care for substance use disorders under the Patient Protection and Affordable Care Act of 2010. Sharing of patient health records among care providers is essential to realize the benefits of electronic health records. Health information exchange through meaningful use of electronic health records can improve health care safety, quality, and efficiency. Implementation of electronic health records and health information exchange presents great opportunities for health care integration, but also makes patient privacy potentially vulnerable. Privacy issues are paramount for patients with substance use problems. This paper discusses major differences between two federal privacy laws associated with health care for substance use disorders, identifies health care problems created by privacy policies, and describes potential solutions to these problems through technology innovation and policy improvement.Keywords: substance abuse, patient privacy, electronic health records, health information exchange

A great divide currently exists between mainstream health care and specialty substance use disorders (SUD) treatment, concerning the coordination of care and sharing of medical information. Improving the coordination of SUD treatment with other disciplines of medicine will benefit SUD patients. The development and use of harmonized electronic health record systems (EHR) containing standardized person-level information will enable improved coordination of healthcare services. We attempt here to illuminate the urgent public health need to develop and implement at the national level harmonized EHR including data fields containing standardized vocabulary/terminologies relevant to SUD treatment. The many advantages and barriers to harmonized EHR implementation in SUD treatment service groups, and pathways to their successful implementation, are also discussed. As the US Federal Government incentivizes Medicare and Medicaid Service providers nationwide for “meaningful use” of health information technology (HIT) systems, relevant stakeholders may face relatively large and time-consuming processes to conform their local practices to meet the federal government’s “meaningful use” criteria unless they proactively implement data standards and elements consistent with those criteria. Incorporating consensus-based common data elements and standards relevant to SUD screening, diagnosis, and treatment into the federal government’s “meaningful use” criteria is an essential first step to develop necessary infrastructure for effective coordination of HIT systems among SUD treatment and other healthcare service providers to promote collaborative-care implementation of cost-effective, evidence-based treatments and to support program evaluations.