OPERATIONS CORE A. Administrative Structure of the Proposed Developmental Center The proposed P20 Alcohol Center will be located within a new unit in the Department of Psychiatry at Penn, the """"""""Center on the Continuum of Care in the Addictions"""""""" (Dr. McKay, Director). This new unit is closely affiliated with the Center for Studies of Addiction (CSA;Dr. Charles O'Brien, Director). The P20 will therefore be able to make use of some of the resources and economies of scale provided by the CSA, as well as from funds provided directly to Dr. McKay to support bjs.new udtlsee letters from Dean Rubenstein, Psychiatry Chair Dr. Evans, and CSA Director Dr. O'Brien, and the Resources section of the grant). We will ensure that the new alcohol center will operate as an independent unit, with its own administrative structure and identity. The independence of the P20 will also be supported by the fact that several key investigators (e.g., McLellan, Cacciola, Carise, Chalk) are located at TRI. This close collaboration with TRI investigators and subcontract with this institute will provide additional resources to the P20 (see below) 1. Leadership of the P20. As Center Director. Dr. McKay will provide overall direction to the P20 and oversee the implementation and progress of the cores and research projects, to ensure that they are consistent with the stated goals of the Center. He is also the PI of the Principal Research Core. Dr. McKay will oversee the working relationships between the Methods and Primary Research cores. He will chair the Steering Committee, and serve as the primary contact person with the two advisory groups. Dr. McKay will serve as the primary link between the proposed alcohol center and other NIAAA alcohol centers, NIAAA program staff, TRI, and collaborating institutions. He will ensure that the main findings of the research conducted at the Center are presented to as wide an audience as possible, including academic, treatment, policy, and public arenas. Where possible, he will initiate collaborations with other alcohol centers, and other NIH centers that address related topics (e.g., adaptive treatment). Dr. McKay will be involved in other Center functions, such as teaching/ training of junior investigators and fellows interested in alcohol research. Finally, he will direct the preparation of a P50 application, should the results from the P20 warrant the development of a larger center. Dr. McKay's role as Scientific Director of the larger CSA places him in a unique position to marshal some of the considerable resources provided by the CSA and the University of Pennsylvania to support the work of the proposed Alcohol Center?and to integrate the important theme and methods from this Center with the community of substance abuse treatment researchers at our institution. These include the biostatistics division, data management unit, centralized intake unit, and pharmacotherapy core treatment unit of the CSA;the network of collaborating substance abuse treatment programs in the Philadelphia area;and University and Department of Psychiatry resources, such as space, library facilities, and other faculty collaborators. The availability of these resources creates an economy of scale, in which a greater percentage of funding for the proposed Alcohol Center can be used specifically to support the research projects and methods development. As the Co-Investigator of the proposed P20 and the PI of the Operations Core, Dr. Oslin will work with Dr. McKay to ensure the scientific value and clinical relevance of all projects conducted at the Center. Dr. Oslin will serve as the primary contact with nonspecialty care treatment providers, including primary care practices at the University of Pennsylvania and the Philadelphia VAMC. Dr. Oslin also directs the Behavioral Health Lab (BHL), which will be used to deliver novel forms of alcohol treatment in the two Developmental Projects. Because of his role as Director of the Philadelphia VA MIRECC, affiliation with Geriatric Psychiatry, and experience working with primary care physicians within and outside of the Penn system, Dr. Oslin is in an excellent position to develop adaptive interventions for alcohol use disorders that will be appealing to and feasible within nonspecialty care service delivery systems such as primary care. 2. Steering Committee. A steering committee has already been formed for the proposed P20 Center, consisting of Drs. McKay, Oslin, Lynch, Carise, Cacciola, and McLellan. This committee now meets weekly, and will continue to do so during the first year of funding. We have found it very productive to meet on a weekly basis and believe that this is the best way to ensure strong collaborative working relationships among members of the Center. The meetings have been used to facilitate the initial design, development, implementation, and coordination of ongoing research projects, and to write the P20. This focus will continue in the first year of funding, with the addition of interactions with our advisory boards. In subsequent years, the focus will shift to monitoring the progress of projects and cores, analysis of project data and planning of manuscripts, design of new studies, planning for additional grant applications (e.g., R21, R01, P50), dissemination to community providers, and sustainability in community settings. Drs. Chalk and Pettinati, who have considerable experience working with community providers and state agencies, and with pharmacotherapy, respectively, will be added to the Steering Committee to facilitate these processes. We expect to meet every other week during years 2-5 of funding, although weekly meetings will be scheduled when needed for more intensive work on project development or management. This committee provides regular internal critique and exchange regarding the day-to-day function of the individual projects and activities within the Center, promotes collaboration between the RMC and PRO, and provides a forum for resolving administrative and budgetary problems. The format for these meetings is designed to meet these three objectives. The first half-hour will be devoted to discussions of personnel actions, project needs, resource allocation, any conflicts, and other administrative issues. The remaining time will be devoted to scientific issues, including discussion of feedback from advisory boards, progress of and results from the Developmental Projects and other center-affiliated projects, theoretical and practical aspects of the work, and constructive suggestions regarding procedures, interpretation of project results, and plans for con- tinued study. The Steering Committee for the P20 will also provide oversight of the scientific quality of manuscripts and grant applications generated by the P20 Center. The committee will set timelines for preparing presentations, publications, and grant applications and other products that will be generated from the Center. Secondarily, it will establish a structure for an internal peer review process among the key Center staff, (see Organizational Chart in Appendix A).

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Program Projects (P01)
Project #
5P01AA016821-02
Application #
7921503
Study Section
Special Emphasis Panel (ZAA1)
Project Start
Project End
Budget Start
2009-09-01
Budget End
2010-08-31
Support Year
2
Fiscal Year
2009
Total Cost
$278,161
Indirect Cost
Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie et al. (2016) Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med 35:1595-615
Lu, Xi; Lynch, Kevin G; Oslin, David W et al. (2016) Comparing treatment policies with assistance from the structural nested mean model. Biometrics 72:10-9
Ertefaie, Ashkan; Wu, Tianshuang; Lynch, Kevin G et al. (2016) Identifying a set that contains the best dynamic treatment regimes. Biostatistics 17:135-48
Van Horn, Deborah H A; Drapkin, Michelle; Lynch, Kevin G et al. (2015) Treatment choices and subsequent attendance by substance-dependent patients who disengage from intensive outpatient treatment. Addict Res Theory 23:391-403
McKay, James R; Drapkin, Michelle L; Van Horn, Deborah H A et al. (2015) Effect of patient choice in an adaptive sequential randomization trial of treatment for alcohol and cocaine dependence. J Consult Clin Psychol 83:1021-32
Oslin, David W; Lynch, Kevin G; Maisto, Stephen A et al. (2014) A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med 29:162-8
McKay, James R (2013) Commentary on Magill & Longabaugh (2013): Specifying the active ingredients in evidence-based treatments-setting the bar too high? Addiction 108:882-3; discussion 883-4
Kranzler, Henry R; McKay, James R (2012) Personalized treatment of alcohol dependence. Curr Psychiatry Rep 14:486-93
McKay, James R (2011) Negative mood, craving, and alcohol relapse: can treatment interrupt the process? Curr Psychiatry Rep 13:431-3
McKay, James R; Van Horn, Deborah; Oslin, David W et al. (2011) Extended telephone-based continuing care for alcohol dependence: 24-month outcomes and subgroup analyses. Addiction 106:1760-9

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