Building Drug Abuse Research at NIDA in Cooperation with the CTSA Consortium

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1 Building Drug Abuse Research at NIDA in Cooperation with the CTSA Consortium ` Nora Volkow, M.D. Director National Institute on Drug Abuse National Institutes of Health

2 Top 10 NIH Institutes and Centers Using CTSA Resources Number of Grants Rece eiving CTSA Support NHLBI NCI NIDDK NIAID NIMH NICHD NINDS NIA NIDA NIAMS Based upon Fiscal Year 2010 data from individual annual progress reports from the first 54 CTSA institutions in 2011.

3 Substance Use Disorders Minimal healthcare involvement Disease with a stigma Serious public health crisis wi ith large number inflicted Costly for society Similar to rare diseases, therapy may not generate big profit Lack of patient advocacy

4 NCATS/CTSAs & NIDA/CTN Much in Common with Room to Grow NCATS/CTSA 33 Univ versities NIDA/CTN Funded in Co ommon Affiliated Universities: Universities: 60? 57 José Szapocznik, Ph.D., PI- CTSI/CTN Universi ity of Miami Kathleen Brady, M.D D., Ph.D., PI CTSI/CTN Medical Universi ity of South Carolina B. Tai 2011

5 NIDA Interactions with CTSAs Mayo CTSA PI Bob Rizza visited NIDA 4/17/2008; NIDA Director visited Mayo CTSA 4/28/08 to 4/29/08 NIDA program officers visited Mayo CTSA on 8/5/08 (met with faculty from 7 departments to discuss possible collaborative projects) Duke CTSA PI Rob Califf visited and met with NIDA staff (7/24/08) Communicated with Harvard CTSA PI Lee Nadler and CIO John Halamka on EMR (7/2/08 ) `

6 Linkages with Practice-Based Research Network (PBRN) (integrating addiction into medical care settings, pain & opioid addiction, nicotine addiction) Potential research proposals smoking, chronic pain management screening/brief intervention of SUD in primary care, emergency care and trauma units

7 NIDA Interactions with CTSAs NIDA prepared and issued a Program Announcement with set aside funds (PAS) targeting research within CTSA Drug Abuse Epidemiology and Services Research Cooperation with the Clinical and Translational Science Awards Consortium (R01) funded 3 projects NIDA hosted a one-day meeting to bring together CTSA leadership and drug abuse researchers to discuss ways to strengthen the integration of drug abuse research as part of the CTSA Consortium s efforts (5/26/10) NIDA staff chaired Think Tank Workshop (8/11) and generated publication on Meaningful Use of Electronic Behavioral Health Data in Primary Health Care, Tai, B et.al., Sci Transl Med 4, 119mr3 (2012). `

8 Applications Fundedd through NIDA PA Transformative Approaches to Reduce Research Disparities Toward Drug Users, PI: Linda B. Cottler, University of Florida Building upon efforts of CTSA site ss community engagement core to examine improved models for recruiting and retaining drug users and other underrepresented populations in clinical trials. A Trial to Prevent Opioid Overdose: E.D. Based Intervention and Take-Home Naloxone, PI: Caleb Banta-Green, University of Washington Utilizing a range of CTSA resources and services in development & implementation of study, including statistical resources, access to data resources, and use of clinical research center. Preventing Drug Abuse Among Hispanic Adolescents, PI: Steven P. Schinke, Columbia University CTSA site supported interdisciplinary collaborations in development and implementation of study, along with providing support from CTSA s biostatistical resources and community engagement core.

9 Ideas for Enhancing Integration It is currently very difficult to penetrate the network especially in attempting to conduct research across multiple CTSA sites. Structurally and organizationally it would be helpful if CTSA funding was structured to incentivize cross-site participation in these types of studies with strong scientific leadership from NIH. Possible strategies could include: ` Building the expectation within the funding announcement that CTSA sites will participate in a certain number of cross-site studies on significant public health research questions established with significant input from NIH, including an NIH science officer. Or, cutting base funding for the CTSA sites and holding back money that would be used to fund scientifically meritorious cross-site research studies on topical areas of interest to NIH.

10 CTSA 2.0 (2013) Provide resources and services to support and speed the planning and implementation of clinical and translational research across the entire range of research and communities NIDA is interested in and ready to participate in every listed research topic 1. Resources for early stage translational research, e.g., high through-put screening, medicinal chemistry, pre-clinical toxicology, target validation 2. Clinical pharmacology units for first in man studies 3. Extensive investment in human physiological phenotyping 4. Biomarker and clinical assessment validation 5. Multi-site collaboration, including expertise in global health (no international funding) 6. Practical trials in health care settings 7. Programs developing innovative models for patient and community engagement in research

11 Opportunities for Future Research CTSA infrastructure can provide wide range of support and critical resources for basic, clinical, and translational research CTSA sites offer possibility of powerful collaborations across vast network of academic and clinical settings, with potential to conduct large-scale, multi-site studies, including: Basic science Epidemiologic and prevention research Clinical trials Clinical quality improvement Organization and delivery of healthcare services Implementation research Economic and cost of healthcare services

12 NIH Pain Consortium Centers of Excellence in Pain Education NIH ICs Involved: ORWH NIA OBSSR NINR NIDA NICHD NIDCR NIAMS NINDS NCCAM ` CoEPEs University of Washington Johns Hopkins University University of Pennsylvania Perelman School of Medicine Southern Illinois University University of Rochester University of New Mexico Harvard School of Dental Medicine University of Alabama at Birmingham Thomas Jefferson University School of Medicine University of California, San Francisco * * * * University of Maryland, Baltimore University of Pittsburgh * * CTSA Institutions * *