NIH/NIDA – The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)

October 1, 2018 by School of Medicine Webmaster

This funding opportunity is being offered as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

This Funding Opportunity Announcement (FOA) invites applications from clinical investigators to participate in the National Drug Abuse Treatment Clinical Trials Network (CTN). NIDA intends to expand research capacity and continue to develop and test interventions for management of the wide spectrum of substance use problems via collaborative partnerships among NIDA, clinical research investigators, healthcare providers, and institutions. The emphasis of this FOA is to: 1) increase the Network’s scientific and clinical research capabilities, and 2) better cover geographic regions across the United States, particularly in regions highly impacted by the opioid overdose epidemic.

NIDA’s CTN was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide. The CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. Over the last two decades, the CTN’s research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements. The CTN has been engaging providers in general medical settings and healthcare systems, and in 2015 the Network built upon and expanded its research portfolio encouraging adoption of innovative bioinformatics approaches, new technology, and “learning healthcare system” principles to enhance the efficiency of SUD clinical research and clinical care.

The CTN currently is comprised of 13 research Nodes that serve as research and training centers, with numerous collaborating healthcare organizations or clinical research sites, and two coordinating centers. The CTN program is administered within NIDA through the Center for the Clinical Trials Network (CCTN). The ongoing opioid epidemic and overdose death crisis present a critical public health need to expeditiously augment the CTN research portfolio to enhance treatment options and improve the quality of opioid use disorder (OUD) treatment. NIDA has decided to expand the CTN infrastructure and research portfolio to address and enhance every stage of the cascade of care for OUD. This includes screening and diagnosis of OUD among those affected; linkage to care among those diagnosed with OUD; opioid agonist, partial agonist, or antagonist medication initiation among those entering care; retention for at least six months among those who initiate medication; and relapse prevention or remission among those retained in care. Research on prevention and early intervention for unhealthy opioid use/misuse is also a high priority. Research on prevention and reversal of opioid overdose in the community and emergency departments is another top priority. This expansion would enhance the CTN’s ability to use cutting-edge research designs, methods, and data resources, consistent with National Academy of Medicine (formerly Institute of Medicine) recommendations for the conduct of clinical research. For example, addition of Nodes with expertise in clinical data science and informatics would bolster the CTN’s capacity to conduct pragmatic studies embedded in clinical practice that will inform care. Additional Nodes located in geographic regions severely affected by the opioid epidemic would allow greater reach and impact of research across the country.

Through this targeted augmentation of the CTN research infrastructure, NIDA proposes to build on the broad portfolio of research that has been conducted in the CTN to: 1) further investigate the use of mobile health technology and other digital tools as well as telemedicine, hub and spoke, and collaborative care models to optimize evidence-based treatment for OUD and improve all steps in cascade of care for OUD, 2) conduct implementation research studies to improve adoption of evidence-based practices, and 3) conduct studies to test innovative care delivery models such as Bridge clinics, patient navigation models, primary care-pharmacy partnerships, patient-centered medical homes (PCMHs), and streamlined admission to treatment to ensure patients receive continuous care to prevent relapse and enhance recovery.

This initiative would build upon the existing NIDA CTN to support 3 – 4 new Nodes that would enhance the Network’s capacity to nimbly respond to urgent public health needs and bring the power of science to bear to reduce morbidity and mortality from opioid misuse and OUD. Successful Nodes will have core faculty with research expertise in addiction medicine, large multi-site clinical trials, and bioinformatics; familiarity with state-level SUD treatment policies; and demonstrated active and ongoing collaboration with health systems and/or research networks in rural and underserved areas.

Desirable features of new Nodes include the following: 1) an experienced SUD treatment expert as the Node PI, 2) ability to engage patients in geographic hot spots of the opioid epidemic, 3) involvement in current state-wide or state-led initiatives to improve access to high quality SUD treatment, 4) history of utilization of implementation science tools and constructs and capacity to conduct implementation research and hybrid implementation-effectiveness research that would have significant direct public health impact, 5) ability to leverage advanced digital technology such as mobile health tools and electronic health record systems (EHR), and 6) ability to conduct research embedded in clinical care that utilizes pragmatic research designs, leverages existing clinical staff, and evaluates interventions or strategies that can be sustainably implemented in rural and other settings that are under-resourced yet highly impacted by the opioid epidemic.

Scope

The focus of this FOA is to expand CTN expertise and resources to address SUD in general and the opioid epidemic specifically. Applications responsive to this FOA should address pressing clinical problems in OUD treatment in general medical settings, specialty care settings, and/or other healthcare settings in accordance with the specific objectives and research topics outlined below. Incomplete and/or non-responsive applications will be withdrawn prior to review.

Objectives

  • Test strategies for the integration of OUD prevention and treatment into general medical settings (such as in primary care, emergency care, and HIV and other infectious disease settings) including strategies linking general medical settings to SUD specialty care settings or vice versa;

  • Evaluate comprehensive OUD treatment models that address co-occurring medical and mental health conditions;

  • Evaluate eHealth and other innovative technologies for improving OUD treatment;

  • Promote use of learning healthcare system principles and practices through research conducted in the CTN that embeds research in clinical care and leverages electronic health record data and existing datasets;

  • Ensure that OUD treatment research encompasses the full spectrum of people affected by SUDs, including racial and ethnic minorities, women, children, adolescents, underserved populations, and other special populations;

  • Generate evidence that will inform and support healthcare policy decisions and clinical guidelines in healthcare settings.

Priority Research Topics

NIDA’s priorities for treatment research topics vary over time, largely in response to public health needs, substance use trends, and other related changes in medical and societal problems, governmental legislation and institutional policies. It is necessary to seize new research opportunities brought about by scientific discoveries and changes in healthcare practices, clinical infrastructures, and research funding.  Examples of high priority research topics include, but are not limited to:

  • Strategies to identify, prevent, and/or intervene for opioid misuse (below threshold of DSM-5 OUD) as well as OUD;
  • Interventions for opioid overdose (OD) prevention;
  • Models of care such as Bridge clinics, pharmacy linkages, and streamlined admission to treatment to sustain hospital- and ED-initiated medication for OUD and to engage patients in ongoing treatment in primary care or specialty settings;
  • Measurement based care (MBC) for managing OUD as a chronic illness;
  • OUD prevention and treatment services particularly in rural communities, including those serving racial/ethnic minorities (such as AI/AN);
  • Effective health communication messaging based on health communication science/dissemination science principles for addressing stigma;
  • Approaches for improving care for comorbid suicide and opioid use risk;
  • Approaches for managing or preventing OUD in patients with HIV, psychiatric disorders, and other co-morbid medical conditions;
  • Approaches (such as Project ECHO) to train and build provider capacity to provide buprenorphine and naltrexone in primary care or initiate buprenorphine in emergency departments (EDs);
  • Organizational and provider-level interventions to promote the uptake and sustainability of effective models of care;
  • Impact of different payment systems (such as those that allow access to high quality integrated SUD treatment) on patient outcomes;
  • Quality measures or other interventions to improve providers’ adherence to best practices for naloxone distribution and providing medication treatment;
  • Technologies to facilitate linkage to treatment and to optimize ongoing OUD treatment and retention;
  • Methods for minimizing patients’ discomfort during opioid withdrawal after overdose reversal.

Organization of the CTN

Nodes: The Node is the functional unit within the CTN and resides within the grantee institution of the cooperative agreement award. The Node:

  • Provides scientific leadership for the clinical trials conducted within the CTN;
  • Proposes, arranges, and coordinates the research, training, and dissemination activities of the network, in collaboration with NIDA and other Nodes;
  • Works collaboratively with the CTN Clinical Coordinating Center (CCC) and Data and Statistics Center (DSC);
  • Builds partnerships with the research organizations (clinical research sites) within the Node and seeks collaborative opportunities with other established networks, such as the CTSAs and the PCORnet, and other relevant research projects;
  • Works with each collaborating research organization as an equal partner.

Specifically, the Node will be responsible for:

Research Agenda: Nodes develop research concepts for potential CTN research projects in close partnership with the clinical and research personnel within its Node, NIDA, and colleagues across the CTN. Nodes submit research proposals to the Research Development Committee (RDC, a subcommittee of the CTN Steering Committee) for discussion and review.

Each collaborating research organization/site agrees to:

  • Designate the Director (or other senior official) of the research site to represent the site for CTN activities and to ensure fulfillment of CTN obligations;
  • Participate fully in the development of research concepts and protocols for studies (in collaboration with the CCC/DSC) to be conducted in the CTN;
  • Participate in clinical studies and adhere fully to Good Clinical Practice (GCP) and to the specific protocol and operations manual applicable to each study;
  • Cooperate with periodic on-site audits by NIDA or its designees to ensure appropriate use of investigational drugs, compliance with all applicable federal, state and local regulations for research on human subjects, including Institutional Review Board (IRB) approval and informed consent (e.g., 45 CFR 46), compliance with protocol specifications, quality assurance and accuracy of data recording and completeness of reporting of adverse drug reactions;
  • Coordinate all data collection and statistical analysis with the DSC and within the parameters and guidance outlined in the CTN policy and procedures.

Training Agenda: The CTN structure provides many opportunities for pre-doctoral, post-doctoral and junior faculty researchers to gain valuable experience in designing, participating in, and managing complex clinical trials and other clinical studies.

Principal Director(s)/Principal Investigator(s) (PD(s)/PI(s)). Nodes are led by the PD(s)/PI(s), who should be able to make a substantive and long-term commitment of effort to CTN responsibilities. The PD(s)/PI(s) are responsible for all projects conducted within their Node.

Center for the Clinical Trials Network (CCTN). The organization within NIDA responsible for the scientific collaboration, administrative oversight, and operational management of the CTN research program.

Data and Statistics Center. The entity established under a contract awarded by NIDA to provide data management and analysis systems as required to implement and support standards established by NIDA’s CCTN. The major tasks of the DSC are to:

  • Establish systems for the collection, management and storage of study data;
  • Plan and perform statistical analyses;
  • Review and monitor the quality of study data;
  • Monitor trial progress;
  • Prepare reports for the Data and Safety Monitoring Board (DSMB);
  • Provide expert consultation and support services as directed by NIDA.

Clinical Coordinating Center. The entity established under a contract awarded by NIDA to provide certain resources and services for CTN clinical trials and other clinical studies, including support for regulatory requirements and oversight functions mandated by NIH and DHHS. The major tasks of the CCC are to:

  • Provide support for the development and maintenance of protocols;
  • Provide support and expertise for regulatory affairs and protection of human subjects;
  • Provide on-site monitoring of clinical study sites and quality assurance support;
  • Serve as NIDA’s safety officer for CTN studies;
  • Provide central pharmacy services for medication packaging, shipping, and inventory control;
  • Provide clinical laboratory support and drug testing;
  • Coordinate the distribution of trial supplies, medications, forms, and manuals;
  • Provide regulatory, quality assurance and training plans for protocols;
  • Provide training in a variety of venues;
  • Provide other expert consultation and support services as needed.

CTN Steering Committee. The Steering Committee (SC) constitutes the primary governing body of the CTN, with representation from each of the Nodes, NIDA, the CTN Clinical Coordinating Center, and the CTN Data and Statistics Center. The SC uses both established and ad hoc committees and workgroups (e.g., Research Development Committee, Publications Committee) to assist in carrying out its functions. The SC meets in person at least annually, and via webinars as the need arises.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See  45 CFR 75.306 for additional details.

Deadline:  December 14, 2018 (full proposals; letters of intent due 30 days prior to that date)

URL:  https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-008.html

Filed Under: Funding Opportunities