Directors Report to the National Advisory Council on

Director’s Report to the National Advisory Council on Drug Abuse February 4, 2009

Director’s Report to the National Advisory Council on Drug Abuse Budget Update What’s New @ NIH? Recent NIDA Activities

NIDA BUDGET (Thousands) 2006 Actual 2007 2008 Budget Authority 2009 C. R. Non. AIDS $698, 976 $699, 852 $703, 263 $699, 168 AIDS $299, 882 $300, 162 $304, 032 $301, 532 $1, 007, 295 $1, 000, 014 +0. 7% +0. 6% $1, 000, 700 TOTAL $998, 858 Increase Over Prior Year -0. 8% -0. 7%

Director’s Report to the National Advisory Council on Drug Abuse Budget Update What’s New @ NIH? Recent NIDA Activities

Change in NIH Leadership… Raynard S. Kington Elias A. Zerhouni NIH Director (Acting) NIH Director October 31, 2008 to Present May 2, 2002 to October 31, 2008 Raynard S. Kington Lawrence A. Tabak, NIH Deputy Director (Acting)

Enhancing Peer Review: Implementation of Recommended Actions January 2009 Update Background Diagnostic Design Implementation Plan Begin Phased Implementation of Selected Actions Peer Review Oversight Committee (PROC) March 2008 – June 2008 Established 4 Working Groups: June 2007 – Feb. 2008 September 2008 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

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) R 01 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

Research, Condition, and Disease Categorization (RCDC) Project • Conceived in 2004 to promote • Consistency • Transparency • Reproducibility • Mandated by Congress – 2006 Dr. Gaya Dowling will present on this at the May 2009 Council Meeting

Director’s Report to the National Advisory Council on Drug Abuse Budget Update What’s New @ NIH? Recent NIDA Activities

Changes in Review of NIDA 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 CHAIR: Mark T. Greenberg, Ph. D. COUNCIL MEMBERS Mary Jane Rotheram-Borus, Ph. D. Marina E. Wolf, Ph. D. Meetings: September 8 -9, 2008 February 2 -3, 2009 ADDITIONAL SENIOR SCIENTISTS Anthony 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. Final Report Due to NIDA Council: May 12, 2009

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network CCTN Betty Tai, Ph. D

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

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D IRP Center for the Clinical Trials Network Betty Tai, Ph. D

Scientific Director Administrative Review Bayview Medical Center April 17 – 18, 2008 Review Committee: Daniele Piomelli, Pharm. D. , Ph. D. (Chair) Professor, Department of Pharmacology University of California, Irvine Dr. Hoffer will give a response to this review Mary Jeanne Kreek, M. D. , Ph. D. Professor, The Rockefeller University Peter W. Kalivas, Ph. D. Professor and Chair, Department of Physiology & Neuroscience Medical 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 Pharmacology Wake Forest University School of Medicine

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research DESPR Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D

Percentage of U. S. 12 th Grade Students Reporting Past Month Use of Cigarettes and Marijuana, 1975 to 2008 40% 30% Cigarettes 20% Marijuana 10% 0% 1978 1982 1986 1990 1994 1998 2002 2006 1976 1980 1984 1988 1992 1996 2000 2004 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.

Drug Abuse Epidemiology & Services Research In Cooperation with the Clinical & Translational Science Award Consortium (R 01) (PAS 09 -001) Issued October 2, 2008 The Interaction of HIV, Drug Use & the Criminal Justice System (R 01) (RFA-DA-09 -007) Issued: September 12, 2008 Letter of Intent Receipt Date: October 27, 2008 Application Due Date: November 25, 2008 Secondary Data Analyses for Substance Abuse Research (R 21/R 33) (RFA-DA-09 -020) Issued November 5, 2008 Letter of Intent Receipt Date: December 29, 2008 Application Due Date: January 28, 2009

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse DPMC Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D

Frank Vocci, Ph. D. Director, DPMCDA Retired January 2, 2009 David Mc. Cann, 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 (P 50) (RFA-DA-09 -002 ) Issued August 27, 2008 Letter of Intent Receipt Date: November 19, 2008 Application Due Date: December 19, 2008

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research DBNBR David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D

Central Nervous System Intersections of Drug Addiction, Chronic Pain and Analgesia (R 01 RFA-DA-09 -017), (R 21 RFA-DA-09 -018), (R 03 RFA-DA-09 -019) Issued October 24, 2008 NIDA set aside $2, 000. NINDS set aside $375, 000. NIDCR did not set aside money, but will consider funding IC-related applications 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.

Behavioral Pharmacology and Genetics: Translating & Targeting Individual Differences (R 03) RFA-DA-09 -016 Issued October 1, 2008 Letter of Intent Receipt Date; December 29, 2008 Application Due Date: January 27, 2009 The Mouse Gene Development Initiative (R 01) (RFA-DA-09 -015) (with NIAAA) Issued October 20, 2008 Letter of Intent Receipt Date: December 29, 2008 Application Due Date: January 27, 2009 Biosignatures of Chronic Drug Exposure (R 21) RFA-DA-09 -022 Issued October 1, 2008 Letter of Intent Receipt Date: December 29, 2008 Application Due Date: January 27, 2009 Optimization of Small Molecule Probes for the Nervous System (R 21) (RFA-NS-09 -003) (with NINDS and NIAAA) Issued December 30, 2008 Letter of Intent Receipt Date: February 3, 2009 Application 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

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research DCNBR Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D

Brain Imaging Drug Use Prevention Messages (R 21) (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

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

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.

Brain Imaging Studies of Negative Reinforcement in Humans (R 01 RFA-DA-09 -008) (R 21 RFA-DA-09 -009) Issued November 5, 2008 Letter of Intent Receipt Date: January 19, 2009 Application Due Date: February 19, 2009 Neuroimaging in Obesity Research (R 01) (RFA-DK-08 -009) (with NIDDK and NIBIB) Issued October 9, 2008 Letter of Intent Receipt Date: February 18, 2009 Application Due Date: March 18, 2009 Imaging – Science Track Award for Transition (I/START) (R 03) PAR-09 -073 Issued January 7, 2009 Exploratory Centers for Translational Research on the Clinical Neurobiology of Drug Addiction (P 20) (RFA-DA-09 -012) Issued September 12, 2008

National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director Mary Affeldt Associate Director for Management Special Populations Office Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D ARP AIDS Research Program Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Epidemiology, Services & Prevention Research Division of Clinical Neuroscience & Behavioral Research Intramural Research Program Frank Vocci, Ph. D Wilson Compton, MD, MPE Joseph Frascella, Ph. D Barry Hoffer, MD, Ph. D Office of Extramural Affairs Teresa Levitin, Ph. D Office of Planning & Resource Management Office of Science Policy & Communications Mary Affeldt Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D

Pre-Application for the 2009 NIDA Avant-Garde Award Program for HIV/AIDS Research (X 02) PA-09 -044 Issued: December 12, 2008 Application Due Date: February 27, 2009 X 02 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 to submit full applications under the following RFA 2009 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP 1) RFA-DA-09 -011 Issued: December 10, 2008 Application Due Date: June 2, 2009

Epigenetics, HIV/AIDS, and Drug Abuse Workshop Thursday, January 22, 2009 Key Research Recommendations 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, and other biological information (e. g. , proteomics, metabolomics)

Christine Colvis, Ph. D. Director of Program Integration OD, NIDA 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 represent NIDA on a number of trans-NIH program teams.

Support Opportunity for Addiction Research (SOAR) for New Investigators (R 03) RFA-DA-09 -021 Issued: 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 commitment of, 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 abuse research component to their on-going research.

Interactions Between Physical Activity & Drug Abuse (R 01 RFA-DA-09 -013) (R 03 RFA-DA-014) October 16 -17, 2008 Letter 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, 2009 In 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 Do. D, VA, NIDA, other NIH ICs and SAMHSA to discuss next steps

IOM Report Published July 2003 “The Committee provides two suggestions for potential mergers for further study: the merger of the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism…” National Institutes of Health Reform Act of 2006 Public Law 109 -482 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 authorities at least every 7 years, provide a report on its review, and make recommendations regarding the use of such authorities.