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

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

Budget Update Budget Update

NIDA BUDGET (Thousands) 2007 PB 2005 Actual 2006 Approp. Non. AIDS $693, 282 $699, NIDA BUDGET (Thousands) 2007 PB 2005 Actual 2006 Approp. Non. AIDS $693, 282 $699, 956 $695, 563 AIDS $313, 137 $300, 073 $299, 266 $1, 006, 419 $1, 000, 029 $994, 829 +1. 2% -0. 6% -0. 5% TOTAL Increase Over Prior Year

What’s New @ NIH? What’s New @ NIH?

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

Cancer For Drug Abuse Research § For the first time in recorded history, Average Cancer For Drug Abuse Research § For the first time in recorded history, Average investment per American annual cancer deaths in the United States have fallen Average investment per American § 10~$8. 60 survivors million ~$1. 50 per year § Improved effectiveness of early detection and screening Millions of People Survivorship 9 6 3 1971 1986 1990 2003 30 -year investment § Thanks to the per American: doubling, new targeted, For Drug Abuse Research minimally invasive treatments for ~$260 cancer multiplied 30 -year investment Total per American ~$44. 00 § New drugs developed for cancer Total prevention

NIH Transforming medicine through discovery NIH Transforming medicine through discovery

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

Recent NIDA Activities Recent NIDA Activities

NIDA Council Workgroups NIDA Council Workgroups

NIDA Basic Science Review Workgroup NIDA Council Linda Porrino, Ph. D, Chair Barry Lester, 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.

NIDA’s Approach to Grant-Making Work Group NIDA Council Constance Weisner, Dr. P. H. , 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. Workgroup Report Will Be Presented Today

Social Neuroscience (RFA-DA-06 -004) Released November 10, 2005 receipt Date: February 23, 2006 61 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

New NIDA PAs and RFAs Cutting-Edge Basic Research Awards (CEBRA) (R 21) (PAR-06 -209) New NIDA PAs and RFAs Cutting-Edge Basic Research Awards (CEBRA) (R 21) (PAR-06 -209) Drug Abuse Aspects of HIV/AIDS and Other Infections (R 21) (PA-06 -309); (R 03) (PA-06 -310) Behavioral Science Track Award for Rapid Transition (B/START) (R 03) (PA-06 -300) Imaging-Science Track Award for Rapid Transition (I/START) (R 03) (PA-06 -311) Drug Abuse Prevention Intervention Research (R 21) (PA-06 -317); (R 03) (PA-06 -318) Inhalant Abuse: Supporting Broad-Based Research Approaches (R 21) (PA-06 -327); (R 03) (PA-06 -328) Women, Sex/Gender Differences and Drug Abuse (R 21) (PA-06 -331); (R 03) (PA-06 -332) Epidemiology of Drug Abuse (R 21) (PA-06 -329); (R 03) (PA-06 -330) Prescription Drug Abuse (R 21) (PA-06 -339); (R 03) (PA-06 -340)

PAs and RFAs Issued With Other NIH Components/Agencies 43 New PAs and 1 New 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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research HIV/AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D 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

HIV Screening as Cost-Effective as Screening for Colon Cancer and Other Conditions 2. 0 HIV Screening as Cost-Effective as Screening for Colon Cancer and Other Conditions 2. 0 1. 8 1. 6 1. 4 Life expectancy 1. 2 1. 0 0. 8 0. 6 0. 4 Quality-adjusted life expectancy 0. 2 0. 0 30 40 50 60 70 80 90 AGE (Yr) Incremental Cost-Effectiveness of Screening ($/quality-adjusted life year) Increase in Life Expectancy Due to Screening (Yr) How can this apply to CJ and other at-risk populations? 200, 000 180, 000 160, 000 140, 000 120, 000 100, 000 80, 000 60, 000 40, 000 20, 000 0 Costs and benefits to partners excluded Costs and benefits to partners included 0. 0 0. 1 0. 2 0. 3 0. 4 0. 5 0. 6 0. 7 0. 8 0. 9 1. 0 Prevalence of Unidentified HIV (%) Paltiel, et al. and Sanders et al. , NEJM 352(6), 2005.

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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D Division of Pharmacotherapies & Medical Consequences of Drug Abuse DPMCDA 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

Outpatient Study: Percent of Negative Urines After Depot Naltrexone Administration Placebo 192 mg Dose Outpatient Study: Percent of Negative Urines After Depot Naltrexone Administration Placebo 192 mg Dose 384 mg Dose 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.

Advantages of Depot Naltrexone • Can be administered once a month • Can be 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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D 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 DESPR

Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) To improve outcomes for offenders with substance 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 Research Centers Coordinating Center

CJ System Replete with Addiction: Access to Medications is Needed Maryland Prison Study: Treatment 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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research DBNBR David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D 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

Whole Genome-wide Association Study Targeting Nicotine Dependence 81 Bullseye 81 SNPs show the most Whole Genome-wide Association Study Targeting Nicotine Dependence 81 Bullseye 81 SNPs show the most difference among the cases and controls

Initial p values of Top 40 K SNPs Non-coding SNP Coding SNP Expected: 44 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

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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network Betty Tai, Ph. D 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 DCNBR

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

National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. National Institute on Drug Abuse Office of the Director Special Populations Office Nora D. Volkow, MD Director Timothy P. Condon, Ph. D. Deputy Director, AIDS Research Laura S. Rosenthal Associate Director for Management Office of Extramural Affairs Teresa Levitin, Ph. D Division of Basic Neurosciences & Behavior Research David Shurtleff, Ph. D Office of Planning & Resource Management Laura Rosenthal Office of Science Policy & Communications Timothy Condon, Ph. D Center for the Clinical Trials Network CCTN Betty Tai, Ph. D 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

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

NIH Roadmap ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH NIDA FY 2004 Roadmap Awards (NIDA’s NIH Roadmap ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH NIDA FY 2004 Roadmap Awards (NIDA’s FY 04 Contribution: $3. 4 M) 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 1 st and 2 nd Year Awards: $4, 555, 473 $5, 686, 171 NIDA FY 2005 Roadmap Awards (NIDA’s FY 05 Contribution: $6. 36 M) 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 NIDA’s Fiscal Investment: FY 2004: $ 3. 403 M FY 2005: $ 6. 363 M FY 2006: $ 9. 026 M FY 2007: $ 12 M

Recent and Upcoming Meetings, Conferences and Events Recent and Upcoming Meetings, Conferences and Events

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

10 th Annual PRISM AWARDS April 27, 2006 10 th Annual PRISM AWARDS April 27, 2006

 • What’s New at NIDA and NIH • Grant Writing Workshop • Novel • What’s New at NIDA and NIH • Grant Writing Workshop • Novel Approaches to Phenotyping Drug Abuse • High Throughput Screening and Using Pub. Chem • 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

Preventing Drug Abuse: A Developmental Science A Congressional Briefing Sponsored by The FRIENDS OF 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)

BLENDING BLENDING

Advantages • May be prescribed in physician’s offices or OTPs • Better safety profile 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