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

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

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

3. NIDA BUDGET (Thousands) 2007Budget Authority 2008Budget Authority 2006Actual 2009C.R. $698,976 $703,263 $304,032 $1,007,295 +0.7% $699,168 $301,532 $1,000,700 -0.7% $699,852 $300,162 $1,000,014 NonAIDS $299,882 AIDS $998,858 TOTAL Increase Over Prior Year -0.8% +0.6%

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

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

6. Background Enhancing Peer Review: Implementation of Recommended ActionsJanuary 2009 Update September 2008 March 2008 – June 2008 June 2007 – Feb. 2008 • Peer Review Oversight Committee (PROC) • Established 4 Working Groups: • 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

7. 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.

8. 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.

9. 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

10. 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

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

12. 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

13. NIDA Prevention Research Review Workgroup CHAIR: Mark T. Greenberg, Ph.D. COUNCIL MEMBERS Mary Jane Rotheram-Borus, Ph.D. Marina E. Wolf, Ph.D. 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. Meetings: September 8-9, 2008 February 2-3, 2009 Final Report Due to NIDA Council: May 12, 2009

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

15. 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

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

17. Review Committee: Daniele Piomelli, Pharm.D., Ph.D. (Chair) Professor, Department of Pharmacology University 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 & 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 Scientific Director Administrative Review Bayview Medical Center April 17 – 18, 2008 Dr. Hoffer will give a response to this review

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

19. Percentage of U.S. 12th Grade Students Reporting Past Month Use of Cigarettes and Marijuana, 1975 to 2008 40% 30% 20% 10% 0% Cigarettes Marijuana 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.

20. 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, 2008 Application Due Date: November 25, 2008 Secondary Data Analyses for Substance Abuse Research (R21/R33) (RFA-DA-09-020) Issued November 5, 2008 Letter of Intent Receipt Date: December 29, 2008 Application Due Date: January 28, 2009

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

22. Frank Vocci, Ph.D. Director, DPMCDA Retired January 2, 2009 David 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

23. Medications Development Centers of Excellence (P50) (RFA-DA-09-002 ) Issued August 27, 2008 Letter of Intent Receipt Date: November 19, 2008 Application Due Date: December 19, 2008

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

25. Central Nervous System Intersections of 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 NIDA set aside $2,000,000. 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.

26. Behavioral Pharmacology and Genetics: Translating & Targeting Individual Differences (R03) 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 (R01) (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 (R21) 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 (R21) (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

27. 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

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

29. Brain Imaging Drug Use Prevention 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

30. 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.

31. 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.

32. Brain Imaging Studies of Negative Reinforcement in Humans(R01 RFA-DA-09-008) (R21 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 (R01) (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) (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

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

34. 2009 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP1) RFA-DA-09-011 Issued: December 10, 2008 Application Due Date: June 2, 2009 Pre-Application for the 2009 NIDA Avant-Garde Award Program for HIV/AIDS Research (X02) PA-09-044 Issued: 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 to submit full applications under the following RFA

35. Epigenetics, HIV/AIDS, and Drug Abuse WorkshopThursday, 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, genomic, and other biological information (e.g., proteomics, metabolomics)

36. 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.  

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

38. Interactions Between Physical Activity & Drug Abuse (R01 RFA-DA-09-013) (R03 RFA-DA-014) October 16-17, 2008 Letter of Intent Receipt Date: December 29, 2008 Application Due Date: January 28, 2009

39. Addressing SUBSTANCE ABUSE & COMORBIDITIES 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

40. 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

41. 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

43. 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.