NIDA Director’s Report: Recent Activities and Budget Update

1. Director’s Report to the National Advisory Council on Drug Abuse May 17, 2006

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

3. Budget Update

4. NIDA BUDGET (Thousands) 2007PB 2005Actual 2006Approp. $693,282 $699,956 $695,563 $299,266 $994,829 NonAIDS $313,137 $300,073 AIDS $1,006,419 $1,000,029 TOTAL Increase Over Prior Year +1.2% -0.6% -0.5%

5. What’s New @ NIH?

6. FY 2007 Budget: NIH and the Transformation of Medicine House Appropriations Subcommittee on Labor/HHS/Education Elias A. Zerhouni, M.D. Director

7. 30-year investment per American: ~$260 Total For Drug Abuse Research Average investment per American ~$1.50 per year Average investment per American ~$8.60 per year For Drug Abuse Research 30-year investment per American ~$44.00 Total Cancer • For the first time in recorded history, annual cancer deaths in the United States have fallen • 10 million survivors • Improved effectiveness of early detection and screening • Thanks to the doubling, new targeted, minimally invasive treatments for cancer multiplied • New drugs developed for cancer prevention Survivorship 9 6 Millions of People 3 1971 1986 1990 2003

8. Transforming medicine through discovery NIH

9. Sharan Jayne 33 Interviews for Radio, TV, and Print Articles Since February 2006

10. Recent NIDA Activities

11. NIDA Council Workgroups

12. NIDA Basic Science Review Workgroup NIDA Council Linda Porrino, Ph.D, Chair Barry Lester, Ph.D. John P. Rice, Ph.D. Members Workgroup Report Will Be Presented Today Frank Ivy Carroll, Ph.D Yasmin Hurd, Ph.D. Guy Cabral, Ph.D. Stanley Watson, M.D., Ph.D. Marina Picciotto, Ph.D. Michael Nader, Ph.D. Kathryn Cunningham, Ph.D.

13. Workgroup Report Will Be Presented Today NIDA’s Approach to Grant-Making Work Group NIDA Council Constance Weisner, Dr.P.H., M.S.W. Chair David Vlahov, Ph.D. Claire E. Sterk, Ph.D. Mark Greenberg, Ph.D. Rodolfo Arredondo, Jr., Ed.D. Linda Porrino, Ph.D. Members Scott Lucas, Ph.D. Kathleen Carroll, Ph.D. Tom Kosten, M.D.

14. Social Neuroscience (RFA-DA-06-004) Released November 10, 2005 receipt Date: February 23, 2006 61 Applications Prescription Opioid Use and Abuse in the Treatment of Pain (RFA-DA-06-005) Released November 18, 2005 Receipt Date: February 23, 2006 89 Applications Epigenetics of Addiction (RFA-DA-06-007) Released October 2, 2005 Receipt Date: January 23, 2006 43 Applications

15. New NIDA PAs and RFAs Cutting-Edge Basic Research Awards (CEBRA) (R21) (PAR-06-209) Drug Abuse Aspects of HIV/AIDS and Other Infections (R21) (PA-06-309); (R03) (PA-06-310) Behavioral Science Track Award for Rapid Transition (B/START) (R03) (PA-06-300) Imaging-Science Track Award for Rapid Transition (I/START) (R03) (PA-06-311) Drug Abuse Prevention Intervention Research (R21) (PA-06-317); (R03) (PA-06-318) Inhalant Abuse: Supporting Broad-Based Research Approaches (R21) (PA-06-327); (R03) (PA-06-328) Women, Sex/Gender Differences and Drug Abuse (R21) (PA-06-331); (R03) (PA-06-332) Epidemiology of Drug Abuse (R21) (PA-06-329); (R03) (PA-06-330) Prescription Drug Abuse (R21) (PA-06-339); (R03) (PA-06-340)

16. PAs and RFAs Issued With Other NIH Components/Agencies 43 New PAs and 1 New RFA • Foci include: • Development • Genetics • HIV/AIDS • Health Services • Health Disparities • Translational • Research

17. NIDA National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Director, AIDS Research HIV/AIDS Research Special Populations Office Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Office of Planning & Resource Management Office of Science Policy & Communications Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD 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 David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Joseph Frascella, PhD Barry Hoffer, MD, PhD

18. 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 Life expectancy Increase in Life Expectancy Due to Screening (Yr) Incremental Cost-Effectiveness of Screening ($/quality-adjusted life year) Quality-adjusted life expectancy Costs and benefits to partners excluded Costs and benefits to partners included 30 40 50 60 70 80 90 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 AGE (Yr) Prevalence of Unidentified HIV (%) HIV Screening as Cost-Effective as Screening for Colon Cancer and Other Conditions How can this apply to CJ and other at-risk populations? Paltiel, et al. and Sanders et al., NEJM 352(6), 2005.

19. The Challenge Now Is to Change the Culture… to Increase Willingness To Accept More Widespread Testing

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

21. Placebo 192 mg Dose 384 mg Dose Outpatient Study: Percent of Negative Urines After Depot Naltrexone Administration 80% 70% 60% 50% 40% 30% 20% 10% 0% 0 2 4 6 8 10 12 14 16 18 Visits (2 per week) Comer, S. D., Sullivan, M. A., Yu, E., Rothenberg, J. L., Kleber, H. D., Kampman, K. et al. Arch Gen Psychiatry, 63, 210-218, 2006.

22. Advantages of Depot Naltrexone • Can be administered once a month • Can be used in the prison system and the criminal justice system…ensuring adherence to treatment • Can be “exported” to countries that have opiate abuse problems but don’t allow agonist therapy- Russia, Egypt • May help to reduce HIV incidence resulting from i.v. drug abuse

23. NIDA National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Director, AIDS Research Special Populations Office Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Office of Planning & Resource Management Office of Science Policy & Communications Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD 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 David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Joseph Frascella, PhD Barry Hoffer, MD, PhD

24. Research Centers Coordinating Center Criminal Justice Drug Abuse Treatment Studies(CJ-DATS) To improve outcomes for offenders with substance use disorders through effective integration of drug abuse treatment, public health, & public safety systems

25. CJ System Replete with Addiction: Access to Medications is Needed Maryland Prison Study: Treatment Linkage and Opiate-Free One Month Post Release (N=100) In Treatment C vs. C+M p < .05 Urine Test Positive C vs. C+T and C+M p < .01 C = Counseling Only; C+T = Counseling & Treatment Referral; C+M = Counseling & Methadone Started in Prison Preliminary Analysis: Tim Kinlock, et al., 2006

26. NIDA National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Director, AIDS Research Special Populations Office Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Office of Planning & Resource Management Office of Science Policy & Communications Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD 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 David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Joseph Frascella, PhD Barry Hoffer, MD, PhD

27. 2.2 Million Perlegen SNPs Top 40,000 SNPs 81 Phase 2 Screen Phase 1 Screen Whole Genome-wide Association Study Targeting Nicotine Dependence 6 Million Common SNPs in Genome Bullseye 81 SNPs show the most difference among the cases and controls

28. Initial p values of Top 40 K SNPs Non-coding SNP Coding SNP Expected: 44 SNPs at 10-4 Observed: 81 SNPs at 10-4 Chromosome

29. presynaptic { Dendritic Spines { postsynaptic De Camilli et al, 2001 MANY OF THESE GENES HAVE SYNAPTIC FUNCTIONS CELL ADHESION NEURO- TRANSMISSION SIGNAL TRANSDUCTION TRANSCRIPTION FACTORS Dean and Dresbach, TINS, 2006

30. NIDA National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Director, AIDS Research Special Populations Office Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Office of Planning & Resource Management Office of Science Policy & Communications Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD 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 David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Joseph Frascella, PhD Barry Hoffer, MD, PhD

31. Using Brain Imaging Technology …to better communicate with adolescents • fMRI used to determine • Coke vs. Pepsi preference • fMRI used to determine • preference for • Super Bowl commercials McClure et al., 2004 Iacoboni et al., 2006

32. NIDA National Institute on Drug Abuse Office of the Director Nora D. Volkow, MD Director Director, AIDS Research Special Populations Office Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Office of Planning & Resource Management Office of Science Policy & Communications Center for the Clinical Trials Network CCTN Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD 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 David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Joseph Frascella, PhD Barry Hoffer, MD, PhD

33. Research Utilization • An Example with Adoption of Buprenorphine • An Example with Adoption of Motivation Incentive Source: Roman et al Presented 2006

34. NIDA’s Fiscal Investment: FY2004: $ 3.403M     FY2005: $ 6.363M                                               FY2006: $ 9.026M                                               FY2007: $ 12M NIH Roadmap ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH NIDA FY 2004 Roadmap Awards (NIDA’s FY04 Contribution: $3.4M)                                                                             Year 1              Year 2  -    7 Grants Awarded to NIDA Researchers:       $2,065,403       $3,139,055 -    15 Grants Related to NIDA’s Research:         $2,490,070$2,547,116 -    Total Amount of 1st and 2nd Year Awards:      $4,555,473       $5,686,171 NIDA FY 2005 Roadmap Awards (NIDA’s FY05 Contribution: $6.36M)                                                               Year 1 -    8 Grants Awarded to NIDA Researchers:     $  1,516,243   -    16 Grants Related to NIDA’s Research:        $ 14,591,510 -    Total Amount of First Year Awards:             $ 16,152,753

35. Recent and Upcoming Meetings, Conferences and Events

36. Recent NIDA Sponsored Meetings Sponsored by New York Academy of Sciences with Brown Medical School February 26-28, 2006

37. 10th Annual PRISM AWARDS April 27, 2006

39. What’s New at NIDA and NIH • Grant Writing Workshop • Novel Approaches to Phenotyping Drug Abuse • High Throughput Screening and Using PubChem • Using Micro Arrays for Research • Overview of the NIH Roadmap and Blueprint • Analysis of the Phase II Study of the Cocaine Vaccine • NIDA International Meeting • Medications Development for Cannabis Dependence • Drug Abuse and HIV/AIDS • New Opportunities for Chemists and Pharmacologists • HIV/AIDS Research in the NIDA CTN • Addressing Ethnic Disparities in Drug Abuse Treatment

40. Preventing Drug Abuse: A Developmental Science A Congressional Briefing Sponsored by The FRIENDS OF NIDA Monday, June 12, 2006 Noon - 2:00 pm (Lunch will be served) Rayburn House Office Building Room 2168 (Gold Room)

41. BLENDING

43. Advantages • May be prescribed in physician’s offices or OTPs • Better safety profile than full agonists • Less likelihood of overdose • Lower abuse potential / lower diversion • Easier to stop: If withdrawal occurs, it’s mild to moderate • Candidate for initial opiate for narcotic addiction therapy • Might be used as a transition to antagonist or drug-free therapy