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Director’s Report to theNational Advisory Council

on Drug Abuse February 4, 2009

Director’s Report to the National Advisory Council on Drug Abuse

Budget Update

Recent NIDA Activities

What’s New @ NIH?

NIDA BUDGET(Thousands)

Increase Increase Over Over Prior YearPrior Year

AIDSAIDS

TOTALTOTAL

NonAIDSNonAIDS $698,976

$299,882

2006Actual

$998,858

-0.8%

2007Budget

Authority

$699,852

$300,162

$1,000,014

+0.6%

2008Budget

Authority

$703,263

$304,032

$1,007,295

+0.7%

2009C.R.

$699,168

$301,532

$1,000,700

-0.7%


Budget Update


What’s New @ NIH?

Elias A. ZerhouniNIH Director

May 2, 2002 to October 31, 2008

Raynard S. KingtonNIH Deputy Director

Change in NIH Leadership…

Raynard S. KingtonNIH Director (Acting)October 31, 2008 to Present

Lawrence A. Tabak, NIH Deputy

Director (Acting)

BackgroundBackground

June 2007 – Feb. 2008 March 2008 – June 2008 September 2008Peer Review Oversight Committee (PROC) Established 4 Working Groups:

1. Engage the Best Reviewers

2. Improve the Quality and Transparency of Review

3. Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages

4. Evaluation: Continuous Review of Peer Review

Enhancing Peer Review: Implementation of Recommended Actions

January 2009 Update

Priority Area 1:Engage the Best Reviewers

Enhance Reviewer Training

• In spring 2009, training will be available to reviewers and Scientific Review Officers related to the changes in peer review.

Allow Flexibility through Virtual Reviews

• Pilots will be conducted in 2009 on the feasibility of using high-bandwidth support for review meetings to provide reviewers greater flexibility and alternatives for in-person meetings.

Priority Area 2:Improve the Quality & Transparency of Review

Scoring to be changed to a 9 point scale with a separate assessment for impact

In 2009, streamlined applications will receive scores on each criterion in addition to critiques to help applicants assess whether or not they should resubmit an amended application

Shorten and Restructure Applications. Shorter (12 page research plan) R01 applications (with other activity codes scaled appropriately) for January 2010 receipt dates

Special considerations for human subjects research (additional material needed for clarification)

The review and scoring process will be changed for most applications submitted for January 2009 deadline and reviewers will use these new guidelines for the

May-June 2009 meetings.

Priority Area 3: Ensure Balanced & Fair Reviews across Scientific Fields & Career Stages & Reduce Administrative Burden

• Fund Meritorious Science Earlier decreasing number of resubmissions (amendments) from two to one

• Identify Early Stage Investigators (ESIs), & establishing goals to encourage funding for new investigators & ESIs

• In 2009, where possible, NIH will cluster new investigator applications for review

Priority Area 4: Continuous Review of Peer Review

• Evaluation group will lay foundation for continuous review of peer review activities

• Conceived in 2004 to promote• Consistency

• Transparency

• Reproducibility

• Mandated by Congress – 2006

Research, Condition, and Disease Categorization (RCDC) Project

Dr. Gaya Dowling will present on this at the May 2009 Council Meeting


Budget Update


What’s New @ NIH?

Changes in Review ofNIDA Grant Applications

• Medications Development Pre-Clinical Research Applications have been transferred to CSR

• Behavioral Treatment Research Applications are in the process of being transferred to CSR

NIDA Prevention Research Review Workgroup

Meetings: September 8-9, 2008February 2-3, 2009

Final Report Due to NIDA Council: May 12, 2009May 12, 2009

CHAIR: Mark T. Greenberg, Ph.D.

COUNCIL MEMBERSMary Jane Rotheram-Borus, Ph.D. Marina E. Wolf, Ph.D.

ADDITIONAL SENIOR SCIENTISTSAnthony Biglan, Ph.D.Dante Cicchetti, Ph.D.Phil Fisher, Ph.D.Marguerita Lightfoot, Ph.D.Michael Neale, Ph.D.Hilda Pantin, Ph.D.Irwin Sandler, Ph.D.

National Institute on Drug Abuse

Office ofExtramural

Affairs

Office of Planning& Resource

Management

Office of Science Policy & Communications

Center for theClinical Trials

Network

Teresa Levitin, PhD Timothy Condon, PhD Betty Tai, PhD

Office of the DirectorNora D. Volkow, MD

Director

Timothy P. Condon, Ph.D.Deputy Director

Mary Affeldt

Associate Director for Management

Mary Affeldt

Division of Basic Neurosciences

& Behavior Research

Intramural ResearchProgram

Division ofEpidemiology,

Services & Prevention Research

Division ofPharmacotherapies &Medical Consequences

of Drug Abuse

David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD

Division of ClinicalNeuroscience &

Behavioral Research

Joseph Frascella, PhD



Wilson Compton, MD, MPE

AIDS Research ProgramSpecial Populations Office

CCTN

CTN-0029 clinical trial designed to: • Evaluate if treating ADHD with osmotic-release

methylphenidate (OROS-MPH) vs. placebo increases the effectiveness of standard smoking treatment (i.e., nicotine patch and counseling) in adult smokers with ADHD

• Evaluate the safety of using OROS-MPH in the treatment of smokers with ADHD

Trial completed (n=255 at 6 sites) in January 2008• Primary data analysis complete• Publication pending

CTN-0029: A Pilot Study of Osmotic-Release Methylphenidate (OROS-MPH) in Initiating and Maintaining Abstinence in Smokers with

Attention Deficit Hyperactivity Disorder (ADHD)


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research






IRP

Scientific Director Administrative Review Bayview Medical Center

April 17 – 18, 2008Review Committee: Daniele Piomelli, Pharm.D., Ph.D. (Chair)Professor, Department of PharmacologyUniversity of California, Irvine

Mary Jeanne Kreek, M.D., Ph.D.Professor, The Rockefeller University

Peter W. Kalivas, Ph.D.Professor and Chair, Department of Physiology & NeuroscienceMedical University of South Carolina

Richard Nakamura, Ph.D.Deputy Director, National Institute of Mental Health

Linda J. Porrino, Ph.D.Professor, Department of Physiology and PharmacologyWake Forest University School of Medicine

Dr. Hoffer will give a response to this review


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research






DESPR

Percentage of U.S. 12th Grade Students Reporting Past Month Use of

Cigarettes and Marijuana, 1975 to 2008

CESAR FAX January 19, 2009, Vol. 18, Issue 2.Adapted by CESAR from University of Michigan, “Trends in 30-Day Prevalence of Use of

Various Drugs in Grades 8, 10, and 12,”Monitoring the Future study, 2008.

Cigarettes

Marijuana

40%

30%

20%

10%

0%1978 1982 1986 1990 1994 1998 2002 2006

1976 1980 1984 1988 1992 1996 2000 2004 2008

Drug Abuse Epidemiology & Services Research In Cooperation with the Clinical & Translational

Science Award Consortium (R01) (PAS 09-001)

Issued October 2, 2008

The Interaction of HIV, Drug Use & the Criminal Justice System (R01)

(RFA-DA-09-007)Issued: September 12, 2008

Letter of Intent Receipt Date: October 27, 2008Application Due Date: November 25, 2008

Secondary Data Analyses for SubstanceAbuse Research (R21/R33)

(RFA-DA-09-020)Issued November 5, 2008

Letter of Intent Receipt Date: December 29, 2008Application Due Date: January 28, 2009


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research






DPMC

Frank Vocci, Ph.D.Director, DPMCDA

Retired January 2, 2009David McCann, Ph.D.Acting Director, DPMCDA

Search for Director, Division of Pharmacotherapies & Medical Consequences of Drug Abuse, NIDA

Search Committee Chair: Barry Hoffer, M.D., Ph.D., Scientific Director, NIDA

Vacancy Announcement # NIDA-09-304337 closes on 3/15/2009

Medications Development Centers of Excellence (P50)

(RFA-DA-09-002 )Issued August 27, 2008

Letter of Intent Receipt Date: November 19, 2008Application Due Date: December 19, 2008


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research






DBNBR

Central Nervous System Intersectionsof Drug Addiction, Chronic Pain

and Analgesia (R01 RFA-DA-09-017),(R21 RFA-DA-09-018), (R03 RFA-DA-09-019)

Issued October 24, 2008

40 Applications Received

To encourage research on CNS changes that occur with chronic pain, and how these changes parallel those that

occur with drug addiction.

NIDA set aside $2,000,000. NINDS set aside $375,000. NIDCR did not set aside money, but will consider

funding IC-related applications

Biosignatures of Chronic Drug Exposure (R21) RFA-DA-09-022Issued October 1, 2008

Letter of Intent Receipt Date: December 29, 2008Application Due Date: January 27, 2009

The Mouse Gene Development Initiative (R01)(RFA-DA-09-015) (with NIAAA)

Issued October 20, 2008Letter of Intent Receipt Date: December 29, 2008

Application Due Date: January 27, 2009

Behavioral Pharmacology and Genetics: Translating & Targeting Individual Differences

(R03) RFA-DA-09-016Issued October 1, 2008

Letter of Intent Receipt Date; December 29, 2008Application Due Date: January 27, 2009

Optimization of Small Molecule Probesfor the Nervous System (R21)

(RFA-NS-09-003) (with NINDS and NIAAA)Issued December 30, 2008

Letter of Intent Receipt Date: February 3, 2009Application Due Date: March 3, 2009

Neuroscience Blueprint Grand Challenge Initiatives

• Grand Challenge on Pain—Harnessing Our Understanding of Neural Plasticity to Elucidate the Transition From Acute to Chronic Pain

• Grand Challenge on Imaging—Human Neuroimaging: Seeing Connections and Molecules

• Grand Challenge on Neurotherapeutics: New Therapies for Diseases of the Nervous System


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research






DCNBR

Brain Imaging Drug UsePrevention Messages (R21)

(RFA-DA-07-007) DCNBR & DESPR

16 Applications – 3 funded

Goals

• To validate models of health communication by identifying neural activation patterns in response to message stimuli

• To discern differences in brain and cognitive processes that lead to differential impact of media messages

• Required collaborative teams of brain imaging and prevention message investigators

Langleben, et al., Neuroimage, in press, uncorrected proof available online 14 January 2009.

High MSV Impedes Retention of PSAs

• Differential Brain Activation by Message Sensation Value (MSV) • High MSV activated posterior cortex (Occipital)• Low MSV activated Prefrontal & Temporal Cortex

• Greater recall of Low MSV• Recall (+) corr w/Frontal & Temporal Pole activation• Recall (-) corr w/post. Temporal Cortex

• Supports “dual processing” & “limited capacity” theories• High MSV attenuates “deep” processing

High MSV Impedes Retention of PSAs

• Greater recall of Low MSV• Recall (+) corr w/ Frontal & Temp Pole activation• Recall (-) corr w/ post. Temporal Cortex

• Supports “dual processing” & “limited capacity” theories• High MSV attenuates “deep” processing

Langleben, et al., Neuroimage, in press, uncorrected proof available online 14 January 2009.

Imaging – Science Track Award for Transition (I/START) (R03) PAR-09-073

Issued January 7, 2009

Exploratory Centers for Translational Research on the Clinical Neurobiology of

Drug Addiction (P20) (RFA-DA-09-012)Issued September 12, 2008

Brain Imaging Studies of Negative Reinforcementin Humans (R01 RFA-DA-09-008) (R21 RFA-DA-09-009)

Issued November 5, 2008Letter of Intent Receipt Date: January 19, 2009

Application Due Date: February 19, 2009

Neuroimaging in Obesity Research (R01)(RFA-DK-08-009) (with NIDDK and NIBIB)

Issued October 9, 2008Letter of Intent Receipt Date: February 18, 2009

Application Due Date: March 18, 2009


Office ofExtramural

Affairs


Management



Network



Director


Mary Affeldt


Mary Affeldt


& Behavior Research





of Drug Abuse



Behavioral Research





AIDS Research ProgramSpecial Populations Office ARP

Pre-Application for the 2009 NIDA Avant-Garde AwardProgram for HIV/AIDS Research (X02)

PA-09-044Issued: December 12, 2008

Application Due Date: February 27, 2009

X02 submissions will be reviewed by external reviewers to identify the most outstanding applications. Those investigators whose applications are

deemed to be the most outstanding will be notified of the opportunity tosubmit full applications under the following RFA

2009 NIDA Avant-Garde AwardProgram for HIV/AIDS Research (DP1)

RFA-DA-09-011Issued: December 10, 2008

Application Due Date: June 2, 2009

Epigenetics, HIV/AIDS, and Drug Abuse WorkshopThursday, January 22, 2009

• What host genes/factors are altered epigenetically by HIV infection?

• Do epigenetic changes associated with drug abuse affect course of HIV disease?

• Does HIV latency and/or transcriptional silencing contribute to HIV spread, persistence or level of viremia?

• How is virus/host interaction impacted by cell type?

• How to integrate epigenomic, genomic, and other biological information (e.g., proteomics, metabolomics)

Key Research Recommendations

In this position she will be facilitating collaboration across NIDA’s Divisions, Offices and Centers as well as across the NIH with an emphasis on program development and will continue to representNIDA on a number of trans-NIH program teams.

Christine Colvis, Ph.D. Director of Program Integration

OD, NIDA

Support Opportunity for Addiction Research (SOAR) for New Investigators (R03)

RFA-DA-09-021Issued: December 12, 2008 (with NIAAA)Letters of Intent Receipt Date: February 3, 2009

Application Due Date: March 3, 2009

These awards will supplement new investigators who have, or have a commitmentof, support to conduct research in basic or clinical alcohol or drug abuse research

from funding sources other than the NIH (e.g. private foundation).

In addition, those applicants currently supported to conduct research on psychiatric disorders that are often found to be co-morbid with

substance abuse, are also eligible to apply for adding a substance or alcohol abuseresearch component to their on-going research.

Interactions Between Physical Activity & Drug Abuse (R01 RFA-DA-09-013) (R03 RFA-DA-014)

October 16-17, 2008Letter of Intent Receipt Date: December 29, 2008

Application Due Date: January 28, 2009

Addressing

Among Military Personnel, Veterans, & Their Families: A Research Agenda

Recent epidemiological reports indicate that military personnel returning from Operation Iraqi Freedom and Operation Enduring Freedom are at higher risk for SUD

Meeting Held January 6-7, 2009In Collaboration with: U.S. Department of Defense

U.S. Army Medical Research and Materiel Command Department of Defense Health Affairs Army Center for Substance Abuse Programs

U.S. Department of Veterans Affairs Other NIH Institutes

NIMH, NIAAA, NHLBI and NCI

Next Steps

• Notice of Intent to Publish a Request for Applications for Trauma, Stress and Substance Use and Abuse among U.S. Military Personnel, Veterans and their Families (NOT-DA-09-004) was released on January 7, 2009 in the NIH Guide

• Report of the meeting will be on the web

• February 2, 2009 small interagency meeting held that included DoD, VA, NIDA, other NIH ICs and SAMHSA to discuss next steps

IOM Report Published July 2003

This bill established a Scientific Management Review Board

to conduct periodic organizational reviews.The Board will be required to examine

the use of NIH's organizational authoritiesat least every 7 years, provide a report on

its review, and make recommendationsregarding the use of such authorities.

National Institutes of HealthReform Act of 2006 Public Law 109-482

“The Committee provides two suggestionsfor potential mergers for further study: the merger of the National Institute onDrug Abuse and the National Instituteon Alcohol Abuse and Alcoholism…”

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