Current and Future Priorities George F Koob PhD Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Cost and Scope of Addiction Prevalence of 12month and Lifetime Alcohol Use Disorders ID: 918761
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Report from the National Institute on Alcohol Abuse and Alcoholism (NIAAA):Current and Future Priorities
George F. Koob, Ph.D.DirectorNational Institute on Alcohol Abuse and AlcoholismNational Institutes of Health
Slide2Cost and Scope of Addiction
Slide3Prevalence of 12-month and Lifetime Alcohol Use Disorders (AUDs) Increased Between 2001-2002 and 2012-2013
2001-2002 NESARC
2012-2013NESARC III
DSM-IV 12-month AUDs
8.5
%
12.7%
DSM-IV Lifetime AUDs
30.3%
43.6%
Past year drinking of at least 5 drinks/ day31%39.6%Past year drinking of at least 8 drinks/ day15.6%20.8%Past year drinking of at least 10 drinks/ day11.5%15.5%
Only 8 out of 100 (7.7%) who met AUD criteria in the previous year got help during that period and 20 out of 100 (19.8%) got help at some point in their lives.
Grant, BF et al JAMA Psychiatry online June 3, 2015.
Slide4Alcohol Issues Across the Lifespan
NIAAA supports research to study how alcohol can affect health and well-being at various stages of life.
Alcohol
Prenatal
Alcohol
Exposure
Binge
Drinking
Organ
Damage
MedicationInteractionsAlcoholDependenceAlcoholicFamilyEnvironmentLifespan Transcending ThemesNeurobiologyMetabolismGenetics Epigenetics EpidemiologyHealth Services Research
Slide5Conceptual Framework for Neurobiological Bases
of the Transition to Excessive Drinking
Slide6Science Policy Branch
Bridget Williams-Simmons
Division of Intramural Clinical and Biological Research
George Kunos
Division of Treatment
and Recovery Research
Robert Huebner (Acting)
Division of Neuroscience and Behavior
Antonio Noronha
Division of Epidemiology and Prevention Research
Ralph HingsonDivision of Metabolism and Health EffectsGary Murray (Acting)
Communications and Public Liaison Branch
Fred Donodeo
Office of Science Policy and Communications
Vivian Faden
Office of Extramural Activities
Abraham Bautista
Extramural Project Review Branch
Ranga
Srinivas
Grants
Management Branch
Judy Fox
Office of the Director
Keith Lamirande, Executive Officer/ Associate Director for Administration
George Koob, Director
Kenneth Warren, Deputy Director
Vivian Faden, Associate Director for Behavioral Research
Patricia Powell, Associate Director for Scientific Initiatives
Office of Resource Management
Keith Lamirande
Administrative
Services Branch
Vicki Buckley
Ethics and Management Analysis Branch
Amy Matush
Financial
Management Branch
Judit O’Connor
Information Technology Branch
Jonathan Folkers
NIAAA Organization
Chart
Alesia Wilbur
, Staff Assistant to the Director
Slide7Budget Highlights for Fiscal years 2014, 2015 and 2016
NIAAA received an appropriation for FY 2015 of $447.2M, 0.9M (0.3%) above the FY 2014 appropriation of $446.3M. In FY 2014, NIAAA awarded a total of 624 Research Project Grants (RPGs) (RPGs =R01, R21, etc.,) including 180
new and competing awardsIn FY2015, NIAAA anticipates supporting a total of 697 RPGs including 167 new and competing awards.In FY 2014 NIAAA also supported, in total:
17
Research Centers
137
Awards including career awards, cooperative agreements, resource grants, etc. 269 Fellowships and training grant slots The President’s Proposed Budget for NIAAA for FY 2016 recommends a 12.7M (2.8%) increase above the FY 2015 appropriation to
$459.8M.
Slide8Highlights of NIAAA Progress: 2014-2015Epidemiological evidence of an increase in Alcohol Use Disorders and intensity of Binge Drinking over the past 10 years
Early Detection/Diagnosis of Fetal Alcohol Spectrum Disorder with 3-dimensional facial imaging and neuropsychological testingAccelerated loss of frontal cortex neurons and projections in heavy drinking adolescent humans and animalsEvidence of epigenetic, neuroinflammatory, microRNA and synaptic mechanisms driving brain pathophysiology of alcohol use disorders
Identification of molecular pathways for alcoholic liver disease in the context of novel validated animal modelsIdentification of disparities of lower alcohol service utilization among minority groups, especially among women
Slide9Exciting New Challenges: 2015-2016
Development of an NIAAA Strategic Plan for 2015- 2019Establishment of a NIAAA- wide consortia coordination for development of treatments for alcoholic liver diseaseEstablishment of a Biosensor challenge and SBIRRelease of College Alcohol Intervention Matrix (AIM)- Fall 2015Launch of Human Laboratory Models Group
Launch of a PTSD/ AUD initiativeLaunch of Adolescent Brain Cognitive Development InitiativeLaunch of an Addiction Research Domain Criteria Conceptual Framework to guide future diagnosis
Slide10NIAAA Strategic Plan: 2015-2019Cross-cutting Themes
Alcohol across the lifespanCommunications and educationHealth disparitiesGeneticsPrecision medicine
Slide11NIAAA Strategic Plan: 2015-2019 — Areas of Focus
Understand and Prevent Alcohol Misuse and Alcohol Use Disorder (AUD)Identify genetic, environmental, epigenetic, and neurobiological factors conferring resilience and vulnerability to AUD Examine neurobiological mechanisms of adolescent alcohol misuse and AUD (NADIA, NCANDA, ABCD)Identify and promote effective preventive interventions for youth (e.g., CollegeAIM)Identify and promote
effective preventive interventions tailored for Native AmericansIncrease adoption of preventive interventions in health care and other settings (e.g., Screening Brief Intervention Referral to Treatment -SBIRT)Expand AUD
Treatment and Recovery Research
Advance precision medicine by
supporting research to evaluate which AUD treatments (behavioral and
pharmacotherapeutic) work best for whomEvaluate the individual and environmental factors that facilitate sustained recovery from AUDEncourage health services research to evaluate the efficacy, accessibility, affordability, and appeal of AUD treatments with a focus on disparities, incarcerated individuals, youth, and pregnant women
Expand medical school curricula to include AUD etiology, prevention, and treatment
Slide12NIAAA Strategic Plan: 2015-2019 — Areas of Focus
Develop AUD MedicationsIdentify novel neurobiological targets for potential AUD therapeuticsConduct human laboratory studies of compounds with promise for treating AUDDevelop AUD therapeutics targeted at each stage of the addiction cycle Raise awareness of FDA-approved medications for treating AUDUnderstand, Prevent, and Treat Co-occurring AUD and PTSDIdentify
the genetic, environmental, epigenetic, and neurobiological factors conferring resilience and vulnerability to comorbid AUD and PTSD Identify neurobiological mechanisms common to PTSD and AUD as potential treatment targetsEvaluate potential therapeutic agents for the treatment of co-morbid PTSD and AUD
Address the Effects of Alcohol on Aging Populations
Develop
and evaluate interventions to prevent the adverse consequences of alcohol misuse among older individuals
Encourage alcohol SBIRT for older adults in healthcare and other settingsEvaluate the potential health benefits of alcohol on older individuals
Slide13NIAAA Strategic Plan: 2015-2019 — Areas of Focus
Prevent, Diagnose, and Treat Fetal Alcohol Spectrum Disorders (FASD)Improve diagnosis of FASD using widely available technologyImprove treatments for FASD, both behavioral and nutritionalPrevent, Diagnose, and Treat Alcoholic Liver
DiseaseImprove diagnosis for early stage liver diseaseDevelop novel treatments for alcoholic hepatitisReduce the Spread of HIV and Improve Health Outcomes for HIV-positive Individuals by Addressing Alcohol Misuse
Slide14NIAAA Proposed Re-organization: Establish the Division of Medications Development (DMD)
Impact:Better reflection of NIAAA prioritiesIncreased emphasis on medications development efforts focused on treating alcohol use disorder (AUD)Change is budget neutral and will utilize existing resources within the institute
Slide15Division of Medications Development (DMD) – Proposed ResponsibilitiesPlans, develops, supports, and manages the medications development program to treat AUD
Develops and standardizes preclinical and clinical laboratory screening models to test promising medicationsAdvances precision medicine to predict favorable responses to specific medicationsAdvises the NIAAA Director on advances in drug development and coordinates programs to establish institute objectives
Slide16Existing NIAAA Organizational Structure
Slide17Proposed NIAAA Organizational Structure
Slide18Behavioral Interventions: New DirectionsDraw upon neuroscience and basic behavioral research to boost the effect size of extant behavioral interventions and develop novel approaches
Understand factors that facilitate or inhibit post-treatment recoveryIntegrate mobile and computer-based technology into behavioral interventionsDevelop and test behavioral interventions for co-occurring PTSD and alcohol use disorders
Slide19Current/Recent CRAN ActivitiesABCD Study
Grantee Meeting
Slide20Goal is to understand
effects of drugs(cannabinoids, alcohol, nicotine) on the developing human brain
Study intends to:
– Assess the impact of sporadic vs regular drug use on the developing brain
– Explore gateway interactions
– Identify neurodevelopmental pathways that link adolescent SUD and mental illnesses
– Assess effect of multiple substances in combination
Large representative cohort (~ 10,000) youth followed over a 10-year period, beginning before drug use into early adulthood Outcome measures--substance use, academic achievement, IQ, cognition
Estimated to cost $30 million/year for 10 years.
Current/Recent CRAN Activities
Slide21RFA Closed April 14, 2015
Excellent response including both linked and unlinked applicationsCSR Setting up Review which will take place in mid-JulyAwards will be made in FY 2015Current/Recent CRAN Activities
Slide22Select Discussion
SummaryCRAN has provided a framework for both preclinical and clinical research and has elevated the status of polysubstance work.Barriers have been removed and investigators can study
topics such as e-cigarettes, co-morbid depression, and prescription drugs, along with alcohol.CRAN may be more important for clinical and delivery science than other areas of substance abuse research. Panelists identified the following needs:
Provide more interdisciplinary training
Educate
reviewers in both translational research and CRAN
researchHave an appropriate structure in place Encourage more conversation between preclinical and clinical investigators about poly substance abuse,
Put more focus on the clinical dilemmas regarding the most effective treatment regimen
Current/Recent CRAN Activities
Slide23Special Messages“What do you know once you know that?”
(from Floyd E. Bloom, Professor Emeritus, The Scripps Research Institute, Editor Emeritus Science Magazine)“Before submitting any grant application to NIAAA, please call your program officer “(from George F. Koob, Director NIAAA)
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Enhancing Reproducibility
Through Rigor & Transparency
Slide25NOT-OD-15-103: Enhancing Reproducibility through Rigor and TransparencyRelease Date: June 9, 2015.
NIH plans to clarify and revise application instructions and existing review criteria, in order to enhance reproducibility of research findings through increased scientific rigor and transparency.These updates, pending approval by the White House Office of Management and Budget, will take effect for applications with receipt dates beginning January 25, 2016.
Slide26Four areas of clarification:Scientific premiseRigorous experimental design
Consideration of relevant biological variables, such as sexAuthentication of key biological and/or chemical resourcesNOT-OD-15-103: Enhancing Reproducibility through Rigor and Transparency
Slide27Scientific PremiseAll research builds upon prior research
, whether observations, preliminary data, or published literature. The scientific premise for an application is the research that is used to form the basis for the proposed research question.NIH expects applicants to describe the general strengths and weaknesses of the prior research being cited by the applicant as crucial to support the application. It is expected that this consideration of general strengths and weaknesses could include attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources.
Slide28Rigorous Experimental Design
Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. NIH expects applicants to describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Robust and unbiased results are obtained using methods designed to avoid bias and these results can be reproduced under well-controlled and reported experimental conditions.
Slide29Consideration of Relevant Biological Variables, Such as SexBiological variables, such as sex, age, weight, and underlying health conditions, are often critical factors affecting health or disease.
NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex. See NOT-OD-15-102 for further consideration of NIH expectations about sex as a biological variable.
Slide30Authentication of Key Biological and/or Chemical ResourcesThe quality of the resources used to conduct research is critical to the ability to reproduce the results. NIH expects that key biological and/or chemical resources will be regularly authenticated to ensure their identity and validity for use in the proposed studies. Key biological and/or chemical resources are those that:
1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research and may or may not be generated with NIH funds
. These include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics.
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Slide32Thank You!George F. Koob, Ph.D.
DirectorNational Institute on Alcohol Abuse and AlcoholismNational Institutes of Health