Clinical Core Stephanie S. O'Malley, Ph.D. Abstract The CTNA Clinical Core serves an important function as the central resource for the diverse clinical projects and pilots. It represents the distinct advantage of an Alcohol Research Center over a cluster of individual grants. The opportunity to fund a central facility with a distinguished leader provides a programmatic method to define needs and assign resources to address central issues. The central components of the Clinical Core are oversight of subject recruitment and clinical assessments, and data management and analysis. The Core also oversees the creation of a cross-project ?Core Database? for investigating phenotypes relevant to the CTNA and its mission.
The specific aims for this core are: A. Centralized monitoring and recruitment of subjects to: 1) Enhance the efficiency of enrollment into each project, including pilots; and 2) Update the Principal Investigators (PIs), the Executive Committee, the Scientific Advisory Board, and the Data Safety Monitoring Board of progress on the protocols. B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across studies; 4) Insure that validated and current assessment tools are used; and 5) Support secondary analyses utilizing core assessments. C. Central provision of data management and biostatistics support to: 1) Provide design and analytical expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-art methods for data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with specialized data analysis expertise related to particular technologies associated with the CTNA, including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety Monitoring Board; and 6) Provide statistical support for all investigators.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Specialized Center (P50)
Project #
5P50AA012870-18
Application #
9493325
Study Section
Special Emphasis Panel (ZAA1)
Project Start
Project End
Budget Start
2018-06-01
Budget End
2019-05-31
Support Year
18
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Yale University
Department
Type
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
D'Souza, Deepak Cyril; Carson, Richard E; Driesen, Naomi et al. (2018) Dose-Related Target Occupancy and Effects on Circuitry, Behavior, and Neuroplasticity of the Glycine Transporter-1 Inhibitor PF-03463275 in Healthy and Schizophrenia Subjects. Biol Psychiatry 84:413-421
Polimanti, Renato; Gelernter, Joel; Stein, Dan J (2018) Genetically determined schizophrenia is not associated with impaired glucose homeostasis. Schizophr Res 195:286-289
Foster, Dawn W; Ye, Feifei; O'Malley, Stephanie S et al. (2018) Longitudinal Associations Between Alcohol-Related Cognitions and Use in African American and European American Adolescent Girls. Alcohol Clin Exp Res 42:962-971
Polimanti, Renato; Gelernter, Joel (2018) ADH1B: From alcoholism, natural selection, and cancer to the human phenome. Am J Med Genet B Neuropsychiatr Genet 177:113-125
Zhou, Hang; Cheng, Zhongshan; Bass, Nicholas et al. (2018) Genome-wide association study identifies glutamate ionotropic receptor GRIA4 as a risk gene for comorbid nicotine dependence and major depression. Transl Psychiatry 8:208
DeMartini, Kelly S; Schilsky, Michael L; Palmer, Amanda et al. (2018) Text Messaging to Reduce Alcohol Relapse in Prelisting Liver Transplant Candidates: A Pilot Feasibility Study. Alcohol Clin Exp Res 42:761-769
Morean, Meghan E; DeMartini, Kelly S; Foster, Dawn et al. (2018) The Self-Report Habit Index: Assessing habitual marijuana, alcohol, e-cigarette, and cigarette use. Drug Alcohol Depend 186:207-214
Mota, Natalie P; Han, Shizhong; Harpaz-Rotem, Ilan et al. (2018) Apolipoprotein E gene polymorphism, trauma burden, and posttraumatic stress symptoms in U.S. military veterans: Results from the National Health and Resilience in Veterans Study. Depress Anxiety 35:168-177
Leeman, Robert F; Nogueira, Christine; Wiers, Reinout W et al. (2018) A Test of Multisession Automatic Action Tendency Retraining to Reduce Alcohol Consumption Among Young Adults in the Context of a Human Laboratory Paradigm. Alcohol Clin Exp Res 42:803-814
Morean, Meghan E; L'Insalata, Alexa; Butler, Ellyn R et al. (2018) Age at drinking onset, age at first intoxication, and delay to first intoxication: Assessing the concurrent validity of measures of drinking initiation with alcohol use and related problems. Addict Behav 79:195-200

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