report from the national institute on alcohol abuse and alcoholism (niaaa): current and future...

Report from the National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Current and Future Priorities

George F. Koob, Ph.D.Director

National Institute on Alcohol Abuse and AlcoholismNational Institutes of Health

Cost and Scope of Addiction

Prevalence of 12-month and Lifetime Alcohol Use Disorders (AUDs) Increased Between

2001-2002 and 2012-2013 2001-2002

NESARC2012-2013NESARC III

DSM-IV 12-month AUDs8.5% 12.7%

DSM-IV Lifetime AUDs30.3% 43.6%

Past year drinking of at least 5 drinks/ day 31% 39.6%

Past year drinking of at least 8 drinks/ day 15.6% 20.8%

Past year drinking of at least 10 drinks/ day 11.5% 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.

Alcohol Issues Across the Lifespan

• NIAAA supports research to study how alcohol can affect health and well-being at various stages of life.

Alcohol

PrenatalAlcohol

Exposure

BingeDrinking Organ

Damage

MedicationInteractions

AlcoholDependence

AlcoholicFamily

Environment

Lifespan Transcending Themes• Neurobiology• Metabolism• Genetics • Epigenetics • Epidemiology• Health Services Research

Conceptual Framework for Neurobiological Basesof the Transition to Excessive Drinking

Science Policy BranchBridget Williams-

Simmons

Division of Intramural Clinical and Biological Research

George Kunos

Division of Treatmentand Recovery ResearchRobert Huebner (Acting)

Division of Neuroscience and Behavior

Antonio Noronha

Division of Epidemiology and Prevention Research

Ralph Hingson

Division of Metabolism and Health Effects

Gary Murray (Acting)

Communications and Public Liaison Branch

Fred Donodeo

Office of Science Policy and

CommunicationsVivian Faden

Office of Extramural Activities

Abraham Bautista

Extramural Project Review BranchRanga Srinivas

GrantsManagement 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

ManagementKeith Lamirande

AdministrativeServices Branch

Vicki Buckley

Ethics and Management

Analysis BranchAmy Matush

FinancialManagement Branch

Judit O’Connor

Information Technology Branch

Jonathan Folkers

NIAAA Organization Chart

Alesia Wilbur, Staff Assistant to the Director

Budget 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 awards

– In 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.

Highlights of NIAAA Progress: 2014-2015• Epidemiological 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 testing

• Accelerated loss of frontal cortex neurons and projections in heavy drinking adolescent humans and animals

• Evidence 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 models

• Identification of disparities of lower alcohol service utilization among minority groups, especially among women

Exciting New Challenges: 2015-2016• Development of an NIAAA Strategic Plan for 2015- 2019

• Establishment of a NIAAA- wide consortia coordination for development of treatments for alcoholic liver disease

• Establishment of a Biosensor challenge and SBIR

• Release of College Alcohol Intervention Matrix (AIM)- Fall 2015

• Launch of Human Laboratory Models Group

• Launch of a PTSD/ AUD initiative

• Launch of Adolescent Brain Cognitive Development Initiative

• Launch of an Addiction Research Domain Criteria Conceptual Framework to guide future diagnosis

NIAAA Strategic Plan: 2015-2019Cross-cutting Themes

• Alcohol across the lifespan

• Communications and education

• Health disparities

• Genetics

• Precision medicine

NIAAA 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 Americans• Increase 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 whom• Evaluate the individual and environmental factors that facilitate sustained recovery

from AUD• Encourage 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


Develop AUD Medications• Identify novel neurobiological targets for potential AUD therapeutics• Conduct human laboratory studies of compounds with promise for treating AUD• Develop AUD therapeutics targeted at each stage of the addiction cycle • Raise awareness of FDA-approved medications for treating AUD

Understand, Prevent, and Treat Co-occurring AUD and PTSD• Identify 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 targets• Evaluate 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 settings• Evaluate the potential health benefits of alcohol on older individuals


Prevent, Diagnose, and Treat Fetal Alcohol Spectrum Disorders (FASD)• Improve diagnosis of FASD using widely available technology• Improve treatments for FASD, both behavioral and nutritional

Prevent, Diagnose, and Treat Alcoholic Liver Disease• Improve diagnosis for early stage liver disease• Develop novel treatments for alcoholic hepatitis

Reduce the Spread of HIV and Improve Health Outcomes for HIV-positive Individuals by Addressing Alcohol Misuse

NIAAA Proposed Re-organization: Establish the Division of Medications

Development (DMD)

Impact:• Better reflection of NIAAA priorities• Increased emphasis on medications development

efforts focused on treating alcohol use disorder (AUD)

• Change is budget neutral and will utilize existing resources within the institute

Division of Medications Development (DMD) – Proposed Responsibilities

• Plans, develops, supports, and manages the medications development program to treat AUD

• Develops and standardizes preclinical and clinical laboratory screening models to test promising medications

• Advances precision medicine to predict favorable responses to specific medications

• Advises the NIAAA Director on advances in drug development and coordinates programs to establish institute objectives

Existing NIAAA Organizational Structure


Division of Intramural Clinical

and Biological Research

Division of Epidemiology and

Prevention Research


Division of Neuroscience and

Behavior

Division of Treatment and

Recovery Research



Communications

Office of Resource Management

Proposed NIAAA Organizational Structure


Division of Intramural Clinical

and Biological Research

Division of Epidemiology and

Prevention Research


Division of Neuroscience and

Behavior

Division of Treatment and

Recovery Research

Division of Medications

Development



Communications

Office of Resource

Management

Behavioral Interventions: New Directions• Draw 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 recovery

• Integrate mobile and computer-based technology into behavioral interventions

• Develop and test behavioral interventions for co-occurring PTSD and alcohol use disorders

Current/Recent CRAN Activities

• ABCD Study • Grantee Meeting

• Goal 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.


RFA Closed April 14, 2015

Excellent response including both linked and unlinked applications

CSR Setting up Review which will take place in mid-July

Awards will be made in FY 2015


Select Discussion Summary• CRAN 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 research

• Have 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


Special 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)

24

Enhancing Reproducibility Through Rigor & Transparency

NOT-OD-15-103: Enhancing Reproducibility through Rigor and Transparency

• Release 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.

Four areas of clarification:

• Scientific premise

• Rigorous experimental design

• Consideration of relevant biological variables, such as sex

• Authentication of key biological and/or chemical resources

NOT-OD-15-103: Enhancing Reproducibility through Rigor and Transparency

Scientific Premise

• All 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.

Rigorous 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.

Consideration of Relevant Biological Variables, Such as Sex

• Biological 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.

Authentication of Key Biological and/or Chemical Resources

• The 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.

Thank You!

George F. Koob, Ph.D.Director

National Institute on Alcohol Abuse and AlcoholismNational Institutes of Health

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