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

Budget Update

NIDA BUDGET (Thousands) Increase Over Prior Year AIDSAIDS TOTALTOTAL NonAIDSNonAIDS $693,282 $313, Actual $1,006, % $699,956 $300, Approp. $1,000, % 2007 PB $695,563 $299,266 $994,829 $695,563 $299,266 $994, %

What’s NIH?

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

Survivorship Millions of People 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 30-year investment per American: ~$260 Total Average investment per American ~$8.60 per year For Drug Abuse Research Average investment per American ~$1.50 per year For Drug Abuse Research 30-year investment per American ~$44.00 Total

NIH Transforming medicine through discovery

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

Recent NIDA Activities

NIDA Council Workgroups

NIDA Basic Science Review Workgroup NIDA Council Members Linda Porrino, Ph.D, Chair Barry Lester, Ph.D. John P. Rice, Ph.D. Linda Porrino, Ph.D, Chair Barry Lester, Ph.D. John P. Rice, Ph.D. 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. 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. Workgroup Report Will Be Presented Today Workgroup Report Will Be Presented Today

Members Scott Lucas, Ph.D. Kathleen Carroll, Ph.D. Tom Kosten, M.D. Scott Lucas, Ph.D. Kathleen Carroll, Ph.D. Tom Kosten, M.D. 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. 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. Workgroup Report Will Be Presented Today Workgroup Report Will Be Presented Today

Social Neuroscience (RFA-DA ) Released November 10, 2005 receipt Date: February 23, Applications Released November 10, 2005 receipt Date: February 23, Applications Prescription Opioid Use and Abuse in the Treatment of Pain (RFA-DA ) Released November 18, 2005 Receipt Date: February 23, Applications Released November 18, 2005 Receipt Date: February 23, Applications Epigenetics of Addiction (RFA-DA ) Released October 2, 2005 Receipt Date: January 23, Applications Released October 2, 2005 Receipt Date: January 23, Applications

New NIDA PAs and RFAs Cutting-Edge Basic Research Awards (CEBRA) (R21) (PAR ) Drug Abuse Aspects of HIV/AIDS and Other Infections (R21) (PA ); (R03) (PA ) Behavioral Science Track Award for Rapid Transition (B/START) (R03) (PA ) Imaging-Science Track Award for Rapid Transition (I/START) (R03) (PA ) Drug Abuse Prevention Intervention Research (R21) (PA ); (R03) (PA ) Inhalant Abuse: Supporting Broad-Based Research Approaches (R21) (PA ); (R03) (PA ) Women, Sex/Gender Differences and Drug Abuse (R21) (PA ); (R03) (PA ) Epidemiology of Drug Abuse (R21) (PA ); (R03) (PA ) Prescription Drug Abuse (R21) (PA ); (R03) (PA ) Cutting-Edge Basic Research Awards (CEBRA) (R21) (PAR ) Drug Abuse Aspects of HIV/AIDS and Other Infections (R21) (PA ); (R03) (PA ) Behavioral Science Track Award for Rapid Transition (B/START) (R03) (PA ) Imaging-Science Track Award for Rapid Transition (I/START) (R03) (PA ) Drug Abuse Prevention Intervention Research (R21) (PA ); (R03) (PA ) Inhalant Abuse: Supporting Broad-Based Research Approaches (R21) (PA ); (R03) (PA ) Women, Sex/Gender Differences and Drug Abuse (R21) (PA ); (R03) (PA ) Epidemiology of Drug Abuse (R21) (PA ); (R03) (PA ) Prescription Drug Abuse (R21) (PA ); (R03) (PA )

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

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

HIV Screening as Cost-Effective as Screening for Colon Cancer and Other Conditions How can this apply to CJ and other at-risk populations? 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), Increase in Life Expectancy Due to Screening (Yr) Increase in Life Expectancy Due to Screening (Yr) Life expectancy Quality-adjusted life expectancy Quality-adjusted life expectancy AGE (Yr) , , , , , ,000 80,000 60,000 40,000 20, , , , , , ,000 80,000 60,000 40,000 20,000 0 Incremental Cost-Effectiveness of Screening ($/quality-adjusted life year) Incremental Cost-Effectiveness of Screening ($/quality-adjusted life year) Costs and benefits to partners excluded Costs and benefits to partners included Prevalence of Unidentified HIV (%)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NIH Roadmap ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH NIDA FY 2004 Roadmap Awards (NIDA’s FY04 Contribution: $3.4M) Year 1 Year Grants Awarded to NIDA Researchers: $2,065,403 $3,139, 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 2004 Roadmap Awards (NIDA’s FY04 Contribution: $3.4M) Year 1 Year Grants Awarded to NIDA Researchers: $2,065,403 $3,139, 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 FY05 Contribution: $6.36M) Year Grants Awarded to NIDA Researchers: $ 1,516, Grants Related to NIDA’s Research: $ 14,591,510 - Total Amount of First Year Awards: $ 16,152,753 NIDA FY 2005 Roadmap Awards (NIDA’s FY05 Contribution: $6.36M) Year Grants Awarded to NIDA Researchers: $ 1,516, Grants Related to NIDA’s Research: $ 14,591,510 - Total Amount of First Year Awards: $ 16,152,753 NIDA’s Fiscal Investment: FY2004: $ 3.403M FY2005: $ 6.363M FY2006: $ 9.026M FY2007: $ 12M FY2005: $ 6.363M FY2006: $ 9.026M FY2007: $ 12M

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

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

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

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 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

Preventing Drug Abuse: A Developmental Science 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) Monday, June 12, 2006 Noon - 2:00 pm (Lunch will be served) Rayburn House Office Building Room 2168 (Gold Room)

BLENDING

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 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