1. Director’s Report to the National Advisory Council on Drug Abuse Director’s Report to the National Advisory Council on Drug Abuse February 12, 2004

2. Recent NIDA Staff Appointments/Changes Recent NIDA Staff Appointments/Changes Richard A. Millstein, J.D. Acting Deputy Director NIH John E. Fogarty International Center for Advanced Study in the Health Sciences Richard A. Millstein, J.D. Acting Deputy Director NIH John E. Fogarty International Center for Advanced Study in the Health Sciences

3. Recent NIDA Staff Appointments/Changes Recent NIDA Staff Appointments/Changes Timothy P. Condon, Ph.D. Deputy Director, NIDA Timothy P. Condon, Ph.D. Deputy Director, NIDA and Director, OSPC NIDA

4. Director’s Report to the National Advisory Council on Drug Abuse Director’s Report to the National Advisory Council on Drug Abuse Science Highlights What’s New at NIH? Budget Update Recent NIDA Activities FY 2004 and Beyond

5. What’s New at NIH?

6. NIH Central Steering Committee Rotating Members (three year terms): Francis Collins Genome Research Institute Richard Hodes Aging Stephen Katz Arthritis Musculoskeletal & Skin Diseases Donald LindbergNational Library of Medicine Stephen StrausComplementary & Alternative Medicine Larry TabakDental & Craniofacial Research Nora VolkowNIDA Rotating Members (three year terms): Francis Collins Genome Research Institute Richard Hodes Aging Stephen Katz Arthritis Musculoskeletal & Skin Diseases Donald LindbergNational Library of Medicine Stephen StrausComplementary & Alternative Medicine Larry TabakDental & Craniofacial Research Nora VolkowNIDA Permanent Members (three largest institutes): Andrew von Eschenbach – National Cancer Institute Barbara Albin – National Heart, Lung and Blood Institute Anthony Fauci – National Institute of Allergy and Infectious Diseases Permanent Members (three largest institutes): Andrew von Eschenbach – National Cancer Institute Barbara Albin – National Heart, Lung and Blood Institute Anthony Fauci – National Institute of Allergy and Infectious Diseases

7. Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges Report by National Research Council and IoM Create a public process for considering proposed changes in the number of NIH institutes or centers. Enhance and increase trans-NIH strategic planning and funding. Create a Director’s Special Projects Program to support high risk, high potential payoff research. Promote innovation and risk-taking in intramural research. 2. 4. 7. 8.

8. THE NIH ROADMAP An Agency-Wide Effort To Identify the Critical Roadblocks and Knowledge Gaps That Constrain Rapid Advances in Biomedical Research Progress Molecular Libraries and Imaging Research Teams of the Future High-Risk Research Private-Public Partnerships Re-engineering the Clinical Research Enterprise Molecular Libraries and Imaging Research Teams of the Future High-Risk Research Private-Public Partnerships Re-engineering the Clinical Research Enterprise

9. What Has NIDA Done to Ensure Participation of Substance Abuse Researchers on the NIH Roadmap? What Has NIDA Done to Ensure Participation of Substance Abuse Researchers on the NIH Roadmap? Dr. Condon named NIDA’s representative for the Roadmap Program officers have contacted potential grantees to encourage them to submit grants for Roadmap RFAs Created a page on NIDA website that highlights opportunities from the roadmap relevant to NIH grantees Periodic staff meetings with NIDA Director to review progress and plan strategies Dr. Condon named NIDA’s representative for the Roadmap Program officers have contacted potential grantees to encourage them to submit grants for Roadmap RFAs Created a page on NIDA website that highlights opportunities from the roadmap relevant to NIH grantees Periodic staff meetings with NIDA Director to review progress and plan strategies

10. Ethics Issues at NIH New Initiatives to Strenthen the NIH Ethics Program: Concern by congress that there may be conflict between the role of NIH directors and of NIH scientists and private partnerships Concern by congress that there may be conflict between the role of NIH directors and of NIH scientists and private partnerships Raynard S. Kington, M.D., Ph.D., NIH Deputy Director, appointed as Deputy Ethics Counselor (DEC) for the NIH and the Office of the Director, NIH Blue Ribbon Panel established to review current NIH Ethics policies NIH Ethics Advisory Committee (NEAC) established (composed of members of the NIH community) Raynard S. Kington, M.D., Ph.D., NIH Deputy Director, appointed as Deputy Ethics Counselor (DEC) for the NIH and the Office of the Director, NIH Blue Ribbon Panel established to review current NIH Ethics policies NIH Ethics Advisory Committee (NEAC) established (composed of members of the NIH community)

11. NIH Consolidation and Centralization Activities (occurring through several approaches) Outsourcing studies: NIH “competes” against outside contractors Extramural Support was studied last year 656 FTEs now in ICs (22 in NIDA) will be centralized into a new NIH Office the “MEO” – Most Efficient Organization -- Implementation Date: April 1, 2004. Outsourcing studies: NIH “competes” against outside contractors Extramural Support was studied last year 656 FTEs now in ICs (22 in NIDA) will be centralized into a new NIH Office the “MEO” – Most Efficient Organization -- Implementation Date: April 1, 2004. NIH Administrative Restructuring Plan – ARAC (Administrative Restructuring and Advisory Committee) Consolidation of functions in several areas including: Personnel, Grants Management, Budget, Acquisitions, Information Technology, Facilities, Financial Maagement and EEO NIH Administrative Restructuring Plan – ARAC (Administrative Restructuring and Advisory Committee) Consolidation of functions in several areas including: Personnel, Grants Management, Budget, Acquisitions, Information Technology, Facilities, Financial Maagement and EEO Harmonization of and accountability for achieving both corporate NIH objectives and IC-specific objectives – Looking at “Dual Reporting” for senior IC staff Harmonization of and accountability for achieving both corporate NIH objectives and IC-specific objectives – Looking at “Dual Reporting” for senior IC staff FTE Ceiling imposed to limit the number of NIH employees at each institute; NIDA’s is 373 in FY04

12. Budget Update

13. NIDA BUDGET (Thousands) Increase Over Prior Year AIDSAIDS TOTALTOTAL NonAIDSNonAIDS $659,431 $301,514 2003 Actual $960,945 +8.2% $677,808 $312,979 2004 Estimate $990,787 +3.0% $703,328 $315,732 2005 P.B. $1,019,060 +2.9%

14. Recent NIDA Activities

15. Treatment Interventions Prevention Research (Children and Adolescents) Novel Approaches to Phenotyping Drug Abuse (RFA) Behavioral and Cognitive Processes in Adolescent Drug Abuse (RFA) Animal Models of Adolescent Drug Abuse (RFA) Prevention Research for the Transition to Adulthood (RFA) Consequences of Marijuana Use on the Developing Brain (RFA) Novel Approaches to Phenotyping Drug Abuse (RFA) Behavioral and Cognitive Processes in Adolescent Drug Abuse (RFA) Animal Models of Adolescent Drug Abuse (RFA) Prevention Research for the Transition to Adulthood (RFA) Consequences of Marijuana Use on the Developing Brain (RFA) New NIDA PAs and RFAs Medications Development for Cannabis-Related Disorders (RFA)

16. Training HIV/HCV Drug Abuse Aspects of HIV/AIDS and Other Infections (PA) HIV/AIDS and Other Infections Among Drug Users in the Criminal Justice System (RFA) Targeted Integrative Research in Drug Abuse and HIV/AIDS in Pregnancy (RFA) Drug Abuse Aspects of HIV/AIDS and Other Infections (PA) HIV/AIDS and Other Infections Among Drug Users in the Criminal Justice System (RFA) Targeted Integrative Research in Drug Abuse and HIV/AIDS in Pregnancy (RFA) New NIDA PAs and RFAs Research Education Grants in Drug Abuse and Addiction (PA)

17. PAs and RFA With Other NIH Components 8 New PAs and 4 New RFAs (Totaling $9.8 Million) 8 New PAs and 4 New RFAs (Totaling $9.8 Million) Focus predominantly on: CO-MORBIDITY Mental illness Alcoholism HIV Focus predominantly on: CO-MORBIDITY Mental illness Alcoholism HIV

18. NIDA/SAMHSA Addiction Technology Transfer Center (ATTC) Blending Initiative NIDA/SAMHSA Addiction Technology Transfer Center (ATTC) Blending Initiative Members of CSAT’s ATTC Network + NIDA Researchers Members of CSAT’s ATTC Network + NIDA Researchers BLENDING TEAMS Buprenorphine awareness training and materials for non-physicians in the drug abuse and addiction field Buprenorphine awareness training and materials for non-physicians in the drug abuse and addiction field Training materials and products to help program managers, administrators and policy makers use Addiction Severity Index (ASI) results for management and program planning decisions Training materials and products to help program managers, administrators and policy makers use Addiction Severity Index (ASI) results for management and program planning decisions

19. Highlights of Recent Meetings and Events Highlights of Recent Meetings and Events

20. Society for Neuroscience Annual Meeting 2002 ~ 471 of 13, 393 2003 ~ 576 of 16,155 2002 ~ 471 of 13, 393 2003 ~ 576 of 16,155 ~~~~ ~~~~ Growth in Drug Abuse-Related Presentations NIDA-Sponsored Mini-Convention Opening Plenary Lecture THE ADDICTED HUMAN BRAIN Nora D. Volkow, M.D., Director, NIDA Opening Plenary Lecture THE ADDICTED HUMAN BRAIN Nora D. Volkow, M.D., Director, NIDA

22. We Recently Released Our New Website for Teens!

23. ...... Educational Seminar for Primary Health Care Providers Co-sponsored by NIDA and the Sheppard Pratt Health System Sheppard Pratt Conference Center Baltimore MD December 17, 2003 Tent at New Year’s Eve Spectacular (widely attended alcohol- drug- and smoke-free community event) Co-sponsored by NIDA in collaboration with the Maryland Chapter of the American Academy of Pediatrics, coalition partners and corporate sponsors Baltimore MD December 31, 2003 Educational Seminar for Primary Health Care Providers Co-sponsored by NIDA and the Sheppard Pratt Health System Sheppard Pratt Conference Center Baltimore MD December 17, 2003 Tent at New Year’s Eve Spectacular (widely attended alcohol- drug- and smoke-free community event) Co-sponsored by NIDA in collaboration with the Maryland Chapter of the American Academy of Pediatrics, coalition partners and corporate sponsors Baltimore MD December 31, 2003 NIDA’s Primary Healthcare Outreach Initiative NIDA’s Primary Healthcare Outreach Initiative

24. Science Highlights

25. Percent of Students Reporting Past Month Use of Any Illicit Drug 19.4 18.2 17.3 16 17 18 19 20 2001 2002 2003 11% Decline 2001 to 2003 Monitoring the Future Study 2003 GREAT NEWS!!

26. Percent of Students Reporting Abuse of Pain Killers in Past 12 Months in 2003 1.7 2.8 3.6 7.2 4.5 10.5 0.0 2.0 4.0 6.0 8.0 10.0 12.0 Oxycontin Vicodin 8th Grade 10th Grade 12th Grade Source: Monitoring the Future Study, 2003. Percent WORRISOME NEWS

27. Numbers of New Abusers of Prescription Drugs: 1965-2001 Numbers of New Abusers of Prescription Drugs: 1965-2001 Source: SAMHSA, 2002 NSDUH

28. Millions of Americans Abuse Prescription Drugs Sedatives Stimulants 0 0 0.5 1 1 1.5 2 2 2.5 3 3 Millions of Americans 3.5 4 4 4.5 1.2 million 2.2 million 4.4 million Use of Prescription Drugs for Non-Medical Purposes 2002 National Survey on Drug Use and Health Use of Prescription Drugs for Non-Medical Purposes 2002 National Survey on Drug Use and Health Pain Relievers

29. Why Has the Abuse of Prescription Drugs Increased?  Increasing numbers of prescriptions (greater availability)  Attention by the media and advertising (television and newspaper)  Easier access (e.g. internet availability)  Improper knowledge and monitoring (adverse effects go unrecognized)  Increasing numbers of prescriptions (greater availability)  Attention by the media and advertising (television and newspaper)  Easier access (e.g. internet availability)  Improper knowledge and monitoring (adverse effects go unrecognized)

30. As Prescriptions Increase Emergency Room Visits For Non-Medical Abuse Have Also Increased Number of Prescriptions (in 1000s) 0 10000 20000 30000 40000 50000 60000 70000 80000 19941995 1996 1997 1998 1999 2000 2001 0 6000 12000 18000 24000 ED Mentions Source: SAMHSA, DAWN, 2002 Hydrocodone Oxycodone prescriptions emergency

31. Increased Media Attention

32. Availability on the Internet Delivered in the Privacy of your Home Availability on the Internet Delivered in the Privacy of your Home “Some reasons why you should consider using this pharmacy” No prescription required! “Some reasons why you should consider using this pharmacy” No prescription required!

33. Other Reasons for Concern  These drugs can have serious medical consequences i.e lethal overdose with pain killers, psychosis with stimulant medications  Misuse in elderly populations who are particularly sensitive to adverse medical reactions  Increase use by adolescents of drugs that may have long term effects in brain development  These drugs can have serious medical consequences i.e lethal overdose with pain killers, psychosis with stimulant medications  Misuse in elderly populations who are particularly sensitive to adverse medical reactions  Increase use by adolescents of drugs that may have long term effects in brain development

34. How Does NIDA’s Science Help Fight Prescription Drug Abuse?

35. Continue Research on Prescription Drugs and on Treatment and Prevention When analgesics are injected they are much more addictive than when taken orally; hence formulations that can interfere with the drug effects if injected would decrease its diversion and abuse

36. Example for Marihuana: As Perceived Risk Increases Use Decreases 0 10 20 30 40 50 60 '75'77'79'81'83'85'87'89'91'93'95'97'99'01'03 % Reporting Use % Reporting Harmfulness % Reporting Use % Reporting Harmfulness What could have accounted for this reduction? Education of patients, physicians, pharmacists and the public Year

37. Development of Alternative Medications with no Drug Abuse Potential

38. FY 2005 and Beyond

39. Treatment Interventions Prevention Research (Children and Adolescents) Gene/Environment Interactions Drug Exposure and the Developing Prenatal Brain The Effects of Drugs of Abuse Across the Lifespan Impact of Drugs, Risky Behavior and HIV on Adolescent Brain Drug Abuse Prevention and Treatment in Primary Care System Neurobiological Processes Underlying Co-morbidity Gene/Environment Interactions Drug Exposure and the Developing Prenatal Brain The Effects of Drugs of Abuse Across the Lifespan Impact of Drugs, Risky Behavior and HIV on Adolescent Brain Drug Abuse Prevention and Treatment in Primary Care System Neurobiological Processes Underlying Co-morbidity NIDA FY 2005 Initiatives Pharmacogenetics and Medications Development Using Science to Improve Providers’ Knowledge and Skills Training

40. genome protein expression neuronal circuits DRUGS OF ABUSE social behavior Systems and Translational Research Approaches in Addiction Systems and Translational Research Approaches in Addiction Infrastructure Development and the Creation of Translational Research Centers

41. Brain, Behavior & Health Roadmap

42. Brain, Behavior & Health Initiative Mission To develop the knowledge and the technology necessary for understanding how the human brain Brain, Behavior & Health Initiative Mission To develop the knowledge and the technology necessary for understanding how the human brain works and molds human behavior, how genes and environmental factors mold its development and function how it changes throughout the lifespan works and molds human behavior, how genes and environmental factors mold its development and function how it changes throughout the lifespan This knowledge will help to better understand brain diseases including ADDICTION, and to develop strategies to promote optimal health

43. Catalog ongoing projects that pertain to a brain/behavior/health initiative Identify scientific questions Identify research areas of redundancy and areas that need to be developed Identify technology or infrastructure that needs to be developed Optimize chances for integrating efforts across research centers, institutes and agencies. Catalog ongoing projects that pertain to a brain/behavior/health initiative Identify scientific questions Identify research areas of redundancy and areas that need to be developed Identify technology or infrastructure that needs to be developed Optimize chances for integrating efforts across research centers, institutes and agencies. FIRST MILESTONE Create a matrix that will

44. Matrix is based on a systems approach including data from all levels of biology: genes, proteins and their complexes, cell, circuits, behavior individual and social. The matrix includes projects in laboratory animals and implicitly addresses development and gender. Matrix is based on a systems approach including data from all levels of biology: genes, proteins and their complexes, cell, circuits, behavior individual and social. The matrix includes projects in laboratory animals and implicitly addresses development and gender. Social Network

45. BRAIN BEHAVIOR & HEALTH ROAD MAP 2. Infrastructure & Projects 2. Infrastructure & Projects 3. Need for Technology 3. Need for Technology 1. Scientific Question 1. Scientific Question GENE PROTEIN CELL CIRCUITS/ PATHWAYS CIRCUITS/ PATHWAYS BEHAVIOR SOCIAL NETWORKS

46. PAs and RFA With Other NIH Components National Cooperative Drug Discovery Groups for the Treatment of Mood Disorders or Nicotine Addiction (NCDDG-MD/NA) Mechanisms of Alcoholic Pancreatitis Neurotechnology Research, Development and Enhancement Bioengineering Research Partnerships HIV/AIDS, Severe Mental Illness and Homelessness (with NIAAA and NIMH) Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (F31) ELSI Regular Research Program (R01) ELSI Small Grant Research Program (R03) Transdisciplinary Tobacco Use Research Centers (with NCI and NIAAA) Group Therapy for Individuals in Drug Abuse or Alcoholism Treatment Screening and Intervention for Youth in Primary Care Settings HIV/AIDS, Drug Use and Highly Vulnerable Youth: Targeting Research Gaps (with NIMH) National Cooperative Drug Discovery Groups for the Treatment of Mood Disorders or Nicotine Addiction (NCDDG-MD/NA) Mechanisms of Alcoholic Pancreatitis Neurotechnology Research, Development and Enhancement Bioengineering Research Partnerships HIV/AIDS, Severe Mental Illness and Homelessness (with NIAAA and NIMH) Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (F31) ELSI Regular Research Program (R01) ELSI Small Grant Research Program (R03) Transdisciplinary Tobacco Use Research Centers (with NCI and NIAAA) Group Therapy for Individuals in Drug Abuse or Alcoholism Treatment Screening and Intervention for Youth in Primary Care Settings HIV/AIDS, Drug Use and Highly Vulnerable Youth: Targeting Research Gaps (with NIMH) PAs RFAs

47. Monitoring the Future Study 2003 Percent of Students Reporting Any Illicit Drug Use in Past Year, by Grade Monitoring the Future Study 2003 Percent of Students Reporting Any Illicit Drug Use in Past Year, by Grade 8th Grade 10th Grade 12th Grade 0 0 10 20 30 40 50 60 75 77 79 81 83 85 87 89 91 93 95 97 99 01 03

48. Recent NIDA Staff Appointments/Changes Steve Oversby, Psy.D. – Medications Research Grants Branch Jennifer Wong, Ph.D. – Regulatory Affairs Branch Steve Oversby, Psy.D. – Medications Research Grants Branch Jennifer Wong, Ph.D. – Regulatory Affairs Branch Susan Weiss, Ph.D. – Chief, Science Policy Branch Robin Mackar, M.P.H. – Deputy Chief, Science Policy Branch Gayathri Jeyarasasingam – Science Policy Branch Susan Weiss, Ph.D. – Chief, Science Policy Branch Robin Mackar, M.P.H. – Deputy Chief, Science Policy Branch Gayathri Jeyarasasingam – Science Policy Branch Division of Treatment Research & Development Office of Science Policy and Communication Arnold Mills -- Acting Chief, Epidemiology Research Branch Kevin Conway, Ph.D. – Deputy Chief, Epidemiology Research Branch Yonette Thomas, Ph.D. -- Deputy Chief, Epidemiology Research Branch Jessica Campbell, Ph.D. – Epidemiology Research Branch Elizabeth Genexi, Ph.D. – Prevention Research Branch Arnold Mills -- Acting Chief, Epidemiology Research Branch Kevin Conway, Ph.D. – Deputy Chief, Epidemiology Research Branch Yonette Thomas, Ph.D. -- Deputy Chief, Epidemiology Research Branch Jessica Campbell, Ph.D. – Epidemiology Research Branch Elizabeth Genexi, Ph.D. – Prevention Research Branch Division of Epidemiology, Services and Prevention Research Center on AIDS and Other Medical Consequences of Drug Abuse Center for the Clinical Trials Network Theresa Montini, Ph.D. Arnaldo R. Quinones, M.D. Theresa Montini, Ph.D. Arnaldo R. Quinones, M.D. Jag H. Khalsa, Ph.D. – Acting Head, Medical Consequences Unit Denise Burns Jag H. Khalsa, Ph.D. – Acting Head, Medical Consequences Unit Denise Burns Office of Extramural Affairs Mark Green, Ph.D. – Deputy Director Office of the Director Cheryl Kassed, M.S.P.H., Ph.D., Special Assistant to the Director Helen Cesari, M.S., Special Assistant to the Deputy Director Cheryl Kassed, M.S.P.H., Ph.D., Special Assistant to the Director Helen Cesari, M.S., Special Assistant to the Deputy Director

49. NIMH NCI NIAID NIAAA NINDS NICHD NIBIB NIDCD NHGRI NCMHD FIC NHLBI NIA NIAMS NIDCR NIDDK NIEHS NEI NIGMS NINR NCRR NCCAM NLM CIT CSR CC NIDA NIH

50. NIDA-Sponsored Mini-Convention Cognition &Behavior:Functional Changes in Synaptic Transmission & Drug Abuse Dr. Susan Volman, DNBR, chair Endocannabinoids in the Brain: From Micro to Macro Drs. Yu Lin and Nancy Pilotte, DNBR, co-chairs Mechanisms of Receptor & Transporter Trafficking Dr. Christine Colvis, DNBR, chair Embryogenesis of Reward-Based Behavior Dr. Robert Riddle, DNBR, chair Young Investigators: Research & Funding Opportunities at NIDA Drs. Susan Volman and Pushpa Thadani, DNBR, co-chairs Signal Transduction Mechanism in Drug Abuse & Addiction Dr. David Shurtleff, DNBR, chair Neurobiological Mechanisms of Drug & Natural Reward Dr. Paul Schnur, DNBR, chair Endocannabinoids in the Brain: From Micro to Macro Drs. Yu Lin and Nancy Pilotte, DNBR, co-chairs Mechanisms of Receptor & Transporter Trafficking Dr. Christine Colvis, DNBR, chair Embryogenesis of Reward-Based Behavior Dr. Robert Riddle, DNBR, chair Young Investigators: Research & Funding Opportunities at NIDA Drs. Susan Volman and Pushpa Thadani, DNBR, co-chairs Signal Transduction Mechanism in Drug Abuse & Addiction Dr. David Shurtleff, DNBR, chair Neurobiological Mechanisms of Drug & Natural Reward Dr. Paul Schnur, DNBR, chair Synaptic Transmission and Excitability: Genetically Encoded Biosensors for Defining Neuronal Circuits and Synaptic Change Synaptic Transmission and Excitability: Genetically Encoded Biosensors for Defining Neuronal Circuits and Synaptic Change Dr. Jonathan Pollock, DNBR, chair