NIAAA: Current and Future Priorities. George F. Koob, Ph.D. Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health

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1 NIAAA: Current and Future Priorities George F. Koob, Ph.D. Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health

2 Cost and Scope of Addiction

3 Alcohol Issues Across the Lifespan NIAAA supports research to study how alcohol can affect health and well-being at various stages of life. Alcohol Lifespan Transcending Themes Neurobiology Metabolism Genetics Epigenetics Epidemiology Health Services Research Alcoholic Family Environment Alcohol Dependence Medication Interactions Prenatal Alcohol Exposure Binge Drinking Organ Damage

4 Special Thanks to Dr. Ken Warren Acting Director NIAAA Deputy Director NIAAA Czar of Fetal Alcohol Syndrome Portfolio

NIAAA Extramural Grant Portfolio, FY 2013 Total Funding $319,759,079 n=955 (sequestration) Neuroscience & Behavior (n=403) $123,522,551 Health Services (n=32) $15,428,018 $42,571,054 $31,428,670

5 NIAAA Extramural Grant Portfolio, FY 2013 Total Funding $319,759,079 n=955 (sequestration) Neuroscience & Behavior (n=403) $123,522,551 Health Services (n=32) $15,428,018 $42,571,054 $31,428,670 Treatment (n=102) $32,443,946 Prevention (n=84) Metabolism & Health Effects (n=239) $74,364,840 Epidemiology (n=95) NIAAA Trans-Divisional Research Emphasis Areas Biomarkers Fetal Alcohol Spectrum Disorders Genes and Environment Health Disparities HIV and AIDS Systems Biology Medications Development International Research Mechanisms of Behavior Change Underage Drinking

6 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6.. Alcoholic Liver Disease 7. HIV/AIDS

7 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6.. Alcoholic Liver Disease 7. HIV/AIDS

8 FASD Research Research Challenges: Improve diagnostic capabilities to determine the full prevalence of Fetal Alcohol Spectrum Disorder (FASD) and identify women and children in need of care and services Improve detection of risk drinking during pregnancy by developing new biomarkers Given the subtlety of FAS facial deficits improve the acumen for FAS facial recognition through 3-D photography and computer analysis Refine our understanding of the complexities in the neurobehavioral phenotype associated with FASD Prevent and/or ameliorate the effects of FASD through nutritional supplementations, pharmacology, or enhanced CNS stimulation

9 FASD Consortia Collaborative Initiative on Fetal Alcohol Spectrum Disorders (FASD) ongoing since 2003 : Consortium of approximately 8 Principal Investigators and many Coinvestigators Animal and human research International project with study sites in U.S., South Africa, Europe, Asia Research from CIFASD was critical to acceptance by APA of a new diagnostic category for Neurobehavioral Disorder: Prenatal Alcohol Exposed Prenatal Alcohol, Sudden Infant Death Syndrome (SIDS)), and Stillbirth (PASS) Joint initiative with NICHD and Deafness Institute On-going since 2003 Study sites in: South and North Dakota population Caucasian and American Indian South Africa mixed ancestry population known as Cape Coloured Major dependent variable is alcohol, secondary tobacco and other drugs (e.g., methamphetamine); study is powered on rarest outcome, i.e., SIDS

10 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6.. Alcoholic Liver Disease 7. HIV/AIDS

Neurobiology of Adolescent Drinking in Adulthood (NADIA) Animal Studies Complementing N-CANDA, NADIA uses animal models to assess the effects of adolescent

11 Neurobiology of Adolescent Drinking in Adulthood (NADIA) Animal Studies Complementing N-CANDA, NADIA uses animal models to assess the effects of adolescent alcohol exposure on the adult brain. Unlike studies with human adolescents, animal studies can control environmental factors and administer alcohol during adolescence.

12 Objectives: National Consortium on Alcohol and Neurodevelopment in Adolescence Study effects of alcohol exposure on trajectory of adolescent brain development in the context of development Examine dose, duration, and timing effects of alcohol exposure Determine what structural and functional anomalies are the result of alcohol exposure and what predates, and may predict, heavy alcohol use Identify neuroimaging and/or neurocognitive brain markers that predict onset of AUD and other psychopathology

13 OHSU Portland Dolf Pfefferbaum Torsten Rohlfing Bonnie Nagel Robert Zucker (SAB) Raquel Gur (SAB) Duncan Clark SRI/Stanford PiLsburgh Ian Colrain Fiona Baker UC San Diego Susan Tapert Sandra Brown Ken Sher (SAB) Sites Advisors Collabora0ons Andrea Hussong (SAB) Duke Mike DeBellis Supporte d by: NIAAA NIMH NICHD NIDA

14 College Drinking College Drinking Intervention Matrix Coming Soon In response to a request from NIAAA s College Presidents Working Group, NIAAA engaged top researchers in the field to develop an interactive, user-friendly, print and online decision support system to help colleges and universities select appropriate strategies to meet their alcohol intervention goals. The tool will allow college presidents and staff to review the strategies they are already using as well as explore others that may serve them better. Users will be able to search for strategies according to intervention level (e.g., individual, group, campus-wide, community) and evaluate other factors, such as effectiveness, barriers and costs, affecting implementation We envision that much like online shopping applications, the online tool will allow users to select a set of strategies for side-by-side comparisons

15 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6.. Alcoholic Liver Disease 7. HIV/AIDS

16 Conceptual Framework for Neurobiological Bases of the Transition to Excessive Drinking

Integrative Neuroscience Initiative on Alcoholism (INIA) NeuroadaptaQon An 11 site multidisciplinary consortium devoted to identifying molecular, cellular, and

The current objective of INIA is to confirm previously identified gene targets and identify druggable targets that are the most promising for medications

17 Integrative Neuroscience Initiative on Alcoholism (INIA) NeuroadaptaQon An 11 site multidisciplinary consortium devoted to identifying molecular, cellular, and behavioral neuroadaptations that occur in the brain due to alcohol exposure that contribute to excessive alcohol consumption in some individuals. The current objective of INIA is to confirm previously identified gene targets and identify druggable targets that are the most promising for medications development for the treatment of alcoholism. This will be achieved using: the extensive INIA genomics data set the INIA mutant mouse and behavioral testing cores INIA electrophysiology expertise

18 Integrative Neuroscience Initiative on Alcoholism (INIA) INIA- Stress A cooperative consortium of 15 Principal Investigators from 9 academic institutions across the US. The INIA stress consortium uses a state-of-the art translational approach (mice, monkeys and humans) to: Ø understand the interaction of genetic variation and stress on the promotion of excessive drinking Ø identify novel, effective and tailored treatment strategies for alcoholism.

This is being accomplished through linkage, GWAS, and whole-exome sequencing studies as well as gene expression and epigenetic

19 Collaborative Study on the Genetics of Alcoholism (COGA) Primary Goal of COGA: To find and understand genes that affect the risk for the development of alcoholism and related disorders. This is being accomplished through linkage, GWAS, and whole-exome sequencing studies as well as gene expression and epigenetic studies. The COGA family pedigrees are densely affected with alcoholism containing at least 2 alcohol-dependent first-degree relatives in addition to an alcohol dependent proband. Participants from 9 US sites

20 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6. Alcoholic Liver Disease 7. HIV/AIDS

NIAAA Medications Development Program for Alcohol Use Disorder (AUD), High-Risk Drinking, and Alcohol-Related Medical Disorders Mission: To improve the care and treatment of those affected by AUD,

21 NIAAA Medications Development Program for Alcohol Use Disorder (AUD), High-Risk Drinking, and Alcohol-Related Medical Disorders Mission: To improve the care and treatment of those affected by AUD, high-risk drinking, and alcohol-related medical disorders by supporting the development of effective and safe medications that are accepted and used by clinicians and patients. Overall Goal: Translate promising medications from discovery to preclinical and human clinical testing to realworld effectiveness and implementation studies.

22 SCREENING MODELS VALIDATION PROCESS: BIDIRECTIONAL INTEGRATION Molecular Targets Animal Models Human Laboratory Models Clinical Trials

NIAAA Clinical Investigation Group PURPOSE (NCIG)

gap between preclinical studies and expensive,

years) Access to many CNS compounds of pharmaceutical

23 NIAAA Clinical Investigation Group PURPOSE (NCIG) Network of Sites for Proof of Concept Trials Bridge gap between preclinical studies and expensive, time-consuming Phase 3 trial Quick turnaround (1½ years) Access to many CNS compounds of pharmaceutical companies Ability to deal with intellectual property Study design flexibility

24 Current NIAAA Priority Programs 1. Fetal Alcohol Syndrome/ Fetal Alcohol Spectrum Disorders 2. Underage and College Drinking 3. Neurobiology of Alcoholism 4. Genetics of Alcoholism 5. Treatment of Alcoholism 6.. Alcoholic Liver Disease 7. HIV/AIDS

Building a New Research Program for Alcoholic

molecular targets Identify best therapeutic

25 Building a New Research Program for Alcoholic Hepatitis Create a rich and fertile environment for new and collaborations Understand the pathogenesis and identify new molecular targets Identify best therapeutic regiments based on patients risk factors, pathogenesis, prognosis

26 Veterans Aging Cohort Study (VACS) The Veterans Aging Cohort Study (VACS) is a prospective, observational cohort study of HIVpositive and an age/race/site matched control group of HIV- negative veterans in care in the United States. The study's aim is to understand the role of comorbid medical and psychiatric disease in determining clinical outcomes in HIV infection. The study has a special focus on the role of alcohol use and abuse in determining clinical outcomes.

27 Future NIAAA Priority Programs 1. Functional Merge: Co-morbidity, Co- training, Co- Prevention, Co- Treatment 2. Neurobiology of Intoxication 3. Sleep and Alcoholism 4. Post traumatic Stress Disorder 5. Standardization of Prevention Options for Middle and Secondary Schools 5. Standardization of Prevention Options for College Campuses

28 Collaborative Research on Addiction at NIH (CRAN)

29 Uber CRAN? National Longitudinal Study of Neurodevelopmental Consequences of Substance Use Study Aims: What is the impact of the sporadic versus the regular use of marijuana, alcohol, nicotine and other substances on the developing brain? What are the neurodevelopmental pathways that link adolescent substance use and pre-existing or emerging mental illnesses? What are the effects of multiple substances in combination? Partnering Agencies: The study will be led by the Collaborative Research on Addiction (CRAN) at NIH (National Institute on Drug Abuse [NIDA], National Institute on Alcohol Abuse and Alcoholism [NIAAA], and the National Cancer Institute [NCI]) in collaboration with the National Institute of Child Health and Human Development (NICHD) and potentially other Institutes (National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH)). We are also seeking partnership with other agencies (CDC, FDA, ONDCP) Study Design: The study will consist of a large representative cohort (i.e. approximately 10,000) youth that will be followed over a 10-year period, beginning before drug use is initiated and continuing into early adulthood.

30 Where we want to be 1. FDA approval for medications for treatment of alcoholism 2. Implementation of effective behavioral treatments for alcoholism 3. Implementation of effective prevention strategies for adolescent drinking 4. Implementation of effective prevention strategies for drinking during pregnancy 5. Elimination of alcohol related HIV pathology 6. Establishment of effective treatments for fetal alcohol spectrum disorder (FASD) 7. Development effective treatments for alcoholic liver disease 8. Appropriate treatment of co-morbidities associated with alcoholism 9. Successful recruitment of young investigators to the alcohol field, elimination of disparities in the alcohol field. Equal pay for women and minorities in the alcohol field

31 Thank You! George F. Koob, Ph.D. Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health

NIAAA: Current Priorities and Future Goals

NIAAA: Current Priorities and Future Goals George F. Koob, Ph.D. Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Alcool : quand l enfant trinque in utero (Alcohol: