1. Director’s Report to the National Advisory Council on Drug Abuse Director’s Report to the National Advisory Council on Drug Abuse February 16, 2005

2. 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 & Events Recent NIDA Activities & Events Policy Issues

3. Budget Update

4. NIDA BUDGET (Thousands) Increase Over Prior Year AIDSAIDS TOTALTOTAL NonAIDSNonAIDS $677,808 $312,979 2004 Actual $990,787 +3.0% $693,282 $313,137 2005 Appropriation $1,006,419 +1.2% $707,026 $303,104 2006 P.B. $1,010,130 +0.4%

5. Policy Issues

6. Sets out broad prohibitions regarding… Outside activities Holdings Awards Sets out broad prohibitions regarding… Outside activities Holdings Awards NEW Supplemental Ethics Regulation That Affects ALL NIH Employees

7. NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research NIH Public Access Policy released February 3, 2005 Requests NIH-funded investigators to release manuscripts as soon as possible and within 12 months of final publication These peer-reviewed publication will be available in a Web-based archive to be managed by the National Library of Medicine (NLM) Provides the public with better access to research publications NIH Public Access Policy released February 3, 2005 Requests NIH-funded investigators to release manuscripts as soon as possible and within 12 months of final publication These peer-reviewed publication will be available in a Web-based archive to be managed by the National Library of Medicine (NLM) Provides the public with better access to research publications

8. NACDA Bioethics Taskforce Immunotherapy Recommendations NACDA Bioethics Taskforce Immunotherapy Recommendations STAGE I Continued development of these promising medications Research that results in clinical trials Preclinical studies of vulnerable populations Research on behavioral consequences Continued development of these promising medications Research that results in clinical trials Preclinical studies of vulnerable populations Research on behavioral consequences Foster and establish partnerships Research to integrate vaccines with psychosocial services Develop combination therapies Preclinical studies in adolescents to ascertain prophylactic use Foster and establish partnerships Research to integrate vaccines with psychosocial services Develop combination therapies Preclinical studies in adolescents to ascertain prophylactic use Clinical trials in adolescents Research on pre- marketing testing Evaluate impact on perceived risks, illicit drug market dynamics, off label use Clinical trials in adolescents Research on pre- marketing testing Evaluate impact on perceived risks, illicit drug market dynamics, off label use STAGE II STAGE III Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches Translate to the Clinic/ Evaluate Prophylactic Potential Translate to the Clinic/ Evaluate Prophylactic Potential Implement/ Ascertain Impact Implement/ Ascertain Impact

9. NIDA Immunotherapy Program Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches Translate to the Clinic/ Evaluate Prophylactic Potential Translate to the Clinic/ Evaluate Prophylactic Potential Implement/ Ascertain Impact Implement/ Ascertain Impact PRESENT ACTIONS PRESENT ACTIONS FUTURE (LONG-TERM) ACTIONS FUTURE (LONG-TERM) ACTIONS FUTURE (LONGER-TERM) ACTIONS FUTURE (LONGER-TERM) ACTIONS Vaccines and/or monoclonal antibodies for cocaine, nicotine, PCP, methamphetamine & MDMA Preclinical S/E studies in adults, pregnant women and fetuses including evaluation of behavioral consequences Vaccines and/or monoclonal antibodies for cocaine, nicotine, PCP, methamphetamine & MDMA Preclinical S/E studies in adults, pregnant women and fetuses including evaluation of behavioral consequences Clinical assessment through CTN, IRP and others Use SBIR/STTR mechanisms to encourage development of adjuvant-mediated optimization Involve constituencies & professional associations in preparing field for adoption/deployment Preclinical studies to evaluate prophylactic potential Preclinical S/E studies in adolescent primates Consider possible develop of vaccine cocktails Clinical assessment through CTN, IRP and others Use SBIR/STTR mechanisms to encourage development of adjuvant-mediated optimization Involve constituencies & professional associations in preparing field for adoption/deployment Preclinical studies to evaluate prophylactic potential Preclinical S/E studies in adolescent primates Consider possible develop of vaccine cocktails Research on ethical, financial, legal, medical consequences of immunotherapies for drug abuse prevention Clinical trials-deploy strategy Monitoring strategies (MTF, CEWG, DAWN) to assess attitude change due to new technology for drug abuse prevention & tx Involve SAMHSA, state health depts. & relevant professional societies to ensure safe adoption Collaborate with SAMHSA, FDA and DOJ to develop policy guidelines and monitor societal impact Research on ethical, financial, legal, medical consequences of immunotherapies for drug abuse prevention Clinical trials-deploy strategy Monitoring strategies (MTF, CEWG, DAWN) to assess attitude change due to new technology for drug abuse prevention & tx Involve SAMHSA, state health depts. & relevant professional societies to ensure safe adoption Collaborate with SAMHSA, FDA and DOJ to develop policy guidelines and monitor societal impact

10. Recent NIDA Activities & Events Recent NIDA Activities & Events

11. Lapse or Relapse to Drug Abuse and Other Chronic Conditions (RFA-DA-05-004) Neurobiology of Behavioral Treatment: Recovery of Brain Structure and Function (RFA-DA-05-006) HIV and Drug Abuse Interventions among Pregnant Women in Drug Abuse Treatment (RFA-DA-05-008) Lapse or Relapse to Drug Abuse and Other Chronic Conditions (RFA-DA-05-004) Neurobiology of Behavioral Treatment: Recovery of Brain Structure and Function (RFA-DA-05-006) HIV and Drug Abuse Interventions among Pregnant Women in Drug Abuse Treatment (RFA-DA-05-008) NIDA RFAs Just Issued

12. 8 New PAs and 8 New RFAs Foci include: Co-morbidity HIV/AIDS Behavior Brain Development Foci include: Co-morbidity HIV/AIDS Behavior Brain Development PAs and RFAs Recently Issued With Other NIH Components/Agencies PAs and RFAs Recently Issued With Other NIH Components/Agencies

13. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research HIV/AIDS Research

14. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research Dr. Jacques Normand

15. Prevention of Drug Abuse Related HIV Infection HIV/AIDS Treatment Issues Related to Drug Abuse and Addiction Epidemiology, Etiology, and Natural History of Drug Abuse-Related HIV/AIDS and its Consequences International Studies on HIV/AIDS and Other Infections in Drug-Using Populations Prevention of Drug Abuse Related HIV Infection HIV/AIDS Treatment Issues Related to Drug Abuse and Addiction Epidemiology, Etiology, and Natural History of Drug Abuse-Related HIV/AIDS and its Consequences International Studies on HIV/AIDS and Other Infections in Drug-Using Populations Office of AIDS Research FY 2006 President’s Budget NIDA Approved Initiatives Office of AIDS Research FY 2006 President’s Budget NIDA Approved Initiatives

16. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research Special Population/ Health Disparities Special Population/ Health Disparities

17. NIDA’s African American Initiative Conducted a preliminary portfolio analysis of NIDA grants Scientific meeting of experts held in October 2004 Articles will be published in the J Health Care Poor Underserved, Fall 2005 Administrative Supplements for Research on the intersection of Drug Use and Criminal Justice Consequences in AA Population released February 10, 2005; Applications due May 1, 2005: Awards will be made by September 30, 2005. “Drugs, African Americans, HIV, and Criminalization: Breaking the Cycle?” Symposium at APA in August 2005 RFA planned for FY 2006 Conducted a preliminary portfolio analysis of NIDA grants Scientific meeting of experts held in October 2004 Articles will be published in the J Health Care Poor Underserved, Fall 2005 Administrative Supplements for Research on the intersection of Drug Use and Criminal Justice Consequences in AA Population released February 10, 2005; Applications due May 1, 2005: Awards will be made by September 30, 2005. “Drugs, African Americans, HIV, and Criminalization: Breaking the Cycle?” Symposium at APA in August 2005 RFA planned for FY 2006

18. Other Special Populations Activities Second National Conference on Health Disparities October 24-26, 2005 in Atlanta, GA Minority Institutions Drug Abuse Research Program (MIDARP) Program Announcement soon to be reissued Summer Research with NIDA Program Provides mentored summer research experiences to minority high school and undergraduate students; significant increase in PI applicants in 2005—87 placements Minority Supplement Program – new name for the PA “Research Supplements to Promote Diversity in Health-Related Research” Second National Conference on Health Disparities October 24-26, 2005 in Atlanta, GA Minority Institutions Drug Abuse Research Program (MIDARP) Program Announcement soon to be reissued Summer Research with NIDA Program Provides mentored summer research experiences to minority high school and undergraduate students; significant increase in PI applicants in 2005—87 placements Minority Supplement Program – new name for the PA “Research Supplements to Promote Diversity in Health-Related Research”

19. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research DBNBR

20. Impact of Diseases of the Nervous System Account for 6 of the top 10 causes of death* Account for 6 of the top 10 causes of death* academic performance workplace productivity social functioning quality of life academic performance workplace productivity social functioning quality of life Sources: * CDC; ** SfN Fact Page Affect 1 in 3 Americans Exact an economic cost of over $500 billion per year** Exact an economic cost of over $500 billion per year** Have a major impact on:

21. genome protein expression neuronal circuits Understand Disease Optimize Health Understand Disease Optimize Health social behavior Integration of Knowledge

22. Blueprint Project Team Lead IC GENSAT expansion NINDS Neurobiology of Disease Training Supplements NIMH Neuroscience Inventory NIDA Project Team Lead IC GENSAT expansion NINDS Neurobiology of Disease Training Supplements NIMH Neuroscience Inventory NIDA FY 2005 ( Tap = 0.15%) 1. Neuroimaging Training 2. Computational Neuroscience 3. Neurobiology of Disease 1. Neuroimaging Training 2. Computational Neuroscience 3. Neurobiology of Disease FY 2006 ( Tap = 0.30%) Project Team Lead IC Core Grants NINDS Neuromouse NIMH Training NIDA Project Team Lead IC Core Grants NINDS Neuromouse NIMH Training NIDA

23. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research DPMCDA

24. Progress in Medication Development Program Medications Development Workgroup Report Has Been Completed Medications Development Workgroup Report Has Been Completed NIDA Response to Recommendations will be discussed at May 2005 Council Meeting NIDA Response to Recommendations will be discussed at May 2005 Council Meeting

25. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research DCNDBT

26. NIH MRI Study of Normal Brain Development Brain Development Cooperative Group Brain Development Cooperative Group

27. Problems with previous studies Sample sizes too small to detect subtle signals Heterogeneity of subject population Little longitudinal data Lack of demographic representativeness Limited behavioral data for brain-behavior correlation Limited MRI data (typically T1 only) Usually limited analysis techniques Sample sizes too small to detect subtle signals Heterogeneity of subject population Little longitudinal data Lack of demographic representativeness Limited behavioral data for brain-behavior correlation Limited MRI data (typically T1 only) Usually limited analysis techniques

28. MRI Study of Normal Brain Development (N=500) Create a database of behavioral and brain MRI development data for 0-18 years Analyze structural-behavioural relationships Develop technique for dissemination of results Create a database of behavioral and brain MRI development data for 0-18 years Analyze structural-behavioural relationships Develop technique for dissemination of results The National Institute for Drug Abuse

29. MRI Objectives Objective 1: Anatomical MRI/Behavior (5-18) Objective 2: Anatomical MRI/Behavior (0-4) Ancillary A: MR Spectroscopy (Single Voxel and MRSI) Ancillary B: Diffusion Tensor Imaging, Relaxometry Objective 1: Anatomical MRI/Behavior (5-18) Objective 2: Anatomical MRI/Behavior (0-4) Ancillary A: MR Spectroscopy (Single Voxel and MRSI) Ancillary B: Diffusion Tensor Imaging, Relaxometry

30. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research CCTN

31. Application Receipt Date: October 14, 2004 Applications Received = 15 Anticipated Award Date: July 2005 Application Receipt Date: October 14, 2004 Applications Received = 15 Anticipated Award Date: July 2005 The National Drug Abuse Treatment Clinical Trials Network (RFA-DA-05-001) Issued July 7, 2004 The National Drug Abuse Treatment Clinical Trials Network (RFA-DA-05-001) Issued July 7, 2004

32. Well-Studied, Sustainable Treatments – CTN-0001: Buprenorphine/Naloxone Detox (Inpatient) – CTN-0002: Buprenorphine/Naloxone Detox (Outpatient) – CTN-0004: Motivational Enhancement Therapy – CTN-0005: Motivational Interviewing – CTN-0006: Motivational Incentives (Drug-Free Clinics) – CTN-0007: Motivational Incentives (Methadone Clinics) – CTN-0011: Telephone Follow-Up Post-Discharge Other Completed Studies – CTN-0008: Baseline Survey – CTN-0012: Perceptions of Infections in SA Tx Program – CTN-0016: Patient Feedback Well-Studied, Sustainable Treatments – CTN-0001: Buprenorphine/Naloxone Detox (Inpatient) – CTN-0002: Buprenorphine/Naloxone Detox (Outpatient) – CTN-0004: Motivational Enhancement Therapy – CTN-0005: Motivational Interviewing – CTN-0006: Motivational Incentives (Drug-Free Clinics) – CTN-0007: Motivational Incentives (Methadone Clinics) – CTN-0011: Telephone Follow-Up Post-Discharge Other Completed Studies – CTN-0008: Baseline Survey – CTN-0012: Perceptions of Infections in SA Tx Program – CTN-0016: Patient Feedback Completed CTN Trials

33. Short Term Bup/Nx Detoxification – High acceptability; many drug free clinics have already adopted Motivational Interviewing – Improved retention for stimulant abusers entering treatment Short Term Bup/Nx Detoxification – High acceptability; many drug free clinics have already adopted Motivational Interviewing – Improved retention for stimulant abusers entering treatment Selected Research Findings Motivational Incentives for Enhanced Drug Abuse Recovery (MIEDAR) – Low cost incentives are effective in promoting treatment retention and abstinence, successfully introduced into community TELE – Higher rate of attendance in post residential treatment with intensive telephone follow-up – Higher rate of abstinence Motivational Incentives for Enhanced Drug Abuse Recovery (MIEDAR) – Low cost incentives are effective in promoting treatment retention and abstinence, successfully introduced into community TELE – Higher rate of attendance in post residential treatment with intensive telephone follow-up – Higher rate of abstinence

34. 1.Randomized control trials of Bup/Nx in assessing liver function in opioid dependence treatment 2.Randomized control trial of OROS MPH in ADHD adolescent with Substance Abuse disorders 3.Randomized control trial of OROS MPH in ADHD adult smokers 4.Prescription Opioid Addiction Treatment (POAT) 1.Randomized control trials of Bup/Nx in assessing liver function in opioid dependence treatment 2.Randomized control trial of OROS MPH in ADHD adolescent with Substance Abuse disorders 3.Randomized control trial of OROS MPH in ADHD adult smokers 4.Prescription Opioid Addiction Treatment (POAT) Future Research Plans

35. NIDA Funding of ATTC “Research/Practice Liaisons” to Forge Linkages with CTN CTN Sites Puerto Rico ATTC Enhancing Linkages to Ensure Research is Used Enhancing Linkages to Ensure Research is Used

36. Dissemination Products Dissemination Products Research Findings Research Findings Create the charge for the Blending Team, based on results of the protocol, and how it can address critical needs in the treatment field Create the charge for the Blending Team, based on results of the protocol, and how it can address critical needs in the treatment field Led by 3 ATTC members & 3 NIDA members Led by 3 ATTC members & 3 NIDA members Hand-Off Meeting Hand-Off Meeting Blending Team Blending Team

37. Short Term Bup/Nx Detoxification Motivational Interviewing Motivational Incentives for Enhanced Drug Abuse Recovery (MIEDAR) Short Term Bup/Nx Detoxification Motivational Interviewing Motivational Incentives for Enhanced Drug Abuse Recovery (MIEDAR) CTN Research Findings – Blending Teams Buprenorphine Treatment – Product released November 2004 Addiction Severity Index (ASI) – Product released December 2004 Buprenorphine Treatment – Product released November 2004 Addiction Severity Index (ASI) – Product released December 2004

38. 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, Development & Behavioral Treatment Division of Clinical Neuroscience, Development & Behavioral Treatment Joseph Frascella, PhD Director, AIDS Research DESPR

39. Update on the Blue Ribbon Task Force Report 1. Define drug abuse services research at NIDA: Achieved 2. Fund more research on organization, management, and economics: Progress made, effort ongoing 3. Develop standards for evidence-based practice: Progress made, effort ongoing 4. Develop collaborative research: Achieved, effort ongoing 5.Fund research to understand widely used common practices that have not been studied: Progress made, effort ongoing 6.Encourage use of research designs that permit causal inferences: Progress made, effort ongoing 1. Define drug abuse services research at NIDA: Achieved 2. Fund more research on organization, management, and economics: Progress made, effort ongoing 3. Develop standards for evidence-based practice: Progress made, effort ongoing 4. Develop collaborative research: Achieved, effort ongoing 5.Fund research to understand widely used common practices that have not been studied: Progress made, effort ongoing 6.Encourage use of research designs that permit causal inferences: Progress made, effort ongoing NIDA has addressed all 6 goals and 24 recommendations of the Blue Ribbon Task Force.

40. Services Research at NIDA: Enhancing Adoption of Evidence-Based Practices CTN as a platform for service studies Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) (SAMHSA co-fund) Primary Care Initiative (SAMHSA co-fund) RFA in FY 2005 on Enhancing State Capacity to Foster Adoption of Science-Based Practices (SAMHSA co-fund) Funding research within the SAMHSA Strategic Prevention Framework program using state epidemiology systems CTN as a platform for service studies Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) (SAMHSA co-fund) Primary Care Initiative (SAMHSA co-fund) RFA in FY 2005 on Enhancing State Capacity to Foster Adoption of Science-Based Practices (SAMHSA co-fund) Funding research within the SAMHSA Strategic Prevention Framework program using state epidemiology systems

41. reach large numbers of people be broadly adopted by different settings be consistently implemented by staff with moderate training/expertise produce replicable and long-lasting effects at a reasonable cost reach large numbers of people be broadly adopted by different settings be consistently implemented by staff with moderate training/expertise produce replicable and long-lasting effects at a reasonable cost What are the characteristics of interventions that can: Future Directions: Key Research Questions

42. Source: Christopherson, KS et al., Cell 120, 421-433, February 11, 2005. Thrombospondins Promote CNS Synaptogenesis `

43. Source: Sanders, GD et al., NEJM 352(6), February 10, 2005. Routine HIV Screening in Health Care Settings Can Provide Important Health & Survival Benefits… Routine HIV Screening in Health Care Settings Can Provide Important Health & Survival Benefits… And Can Be As Cost-Effective As Screening for Such Other Conditions As Breast Cancer & Hypertension And Can Be As Cost-Effective As Screening for Such Other Conditions As Breast Cancer & Hypertension Increase in Life Expectancy Due to Screening (Yr) 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 30 40 50 60 70 80 90 Life expectancy Quality-adjusted life expectancy AGE (Yr) 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 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 (%)

44. NIDA-Sponsored/Chaired Symposia at the Annual Meeting of the American College of Neuropsychopharmacology NIDA-Sponsored/Chaired Symposia at the Annual Meeting of the American College of Neuropsychopharmacology Substance Abuse in the 21 st Century: What Problems Lie Ahead for the Baby Boomers? The Neurobiology of Obesity: Relations to Addiction Glia and Astrocytes as Modulators of Synaptic Function Molecular Genetics of Addiction Vulnerability and Treatment Predictors of Treatment Response and Relapse: Neurobiological Markers Substance Abuse in the 21 st Century: What Problems Lie Ahead for the Baby Boomers? The Neurobiology of Obesity: Relations to Addiction Glia and Astrocytes as Modulators of Synaptic Function Molecular Genetics of Addiction Vulnerability and Treatment Predictors of Treatment Response and Relapse: Neurobiological Markers

47. Summary of NIH-Specific Provisions in Interim Final Rule Prohibited Outside Activities – 5 C.F.R. §5501.109 Summary of NIH-Specific Provisions in Interim Final Rule Prohibited Outside Activities – 5 C.F.R. §5501.109 What activities are not allowed? For all NIH employees – compensated or uncompensated employment, including consulting & advisory or other board service, & compensated teaching, speaking, writing, or editing is now prohibited with or for: substantially affected organizations (defined to include biotechnology, pharmaceutical, medical device companies, and others with similar interests) hospitals, clinics, health maintenance organizations, or other health care providers health insurers health, science, or health research-related trade organizations, professional associations, or consumer or advocacy groups educational institutions or non-profit independent research institutes that are or recently were NIH funding applicants, grantees, contractors, or CRADA partners Employees are also prohibited from engaging in self-employment activities that involve the sale or promotion of the services or products of the above entities. What activities are not allowed? For all NIH employees – compensated or uncompensated employment, including consulting & advisory or other board service, & compensated teaching, speaking, writing, or editing is now prohibited with or for: substantially affected organizations (defined to include biotechnology, pharmaceutical, medical device companies, and others with similar interests) hospitals, clinics, health maintenance organizations, or other health care providers health insurers health, science, or health research-related trade organizations, professional associations, or consumer or advocacy groups educational institutions or non-profit independent research institutes that are or recently were NIH funding applicants, grantees, contractors, or CRADA partners Employees are also prohibited from engaging in self-employment activities that involve the sale or promotion of the services or products of the above entities.

48. Teaching a course that requires multiple presentations and is part of the established curriculum of a university or college Teaching, speaking, or writing performed as part of a continuing professional education program Employment with political, religious, social, fraternal, or recreational organizations Clinical, medical, or health-related professional practice involving provision of care to individual patients Clerical or similar services Authorship of articles, chapters or textbooks that are subject to a peer review or substantially equivalent editorial review process Teaching a course that requires multiple presentations and is part of the established curriculum of a university or college Teaching, speaking, or writing performed as part of a continuing professional education program Employment with political, religious, social, fraternal, or recreational organizations Clinical, medical, or health-related professional practice involving provision of care to individual patients Clerical or similar services Authorship of articles, chapters or textbooks that are subject to a peer review or substantially equivalent editorial review process Summary of NIH-Specific Provisions in Interim Final Rule Prohibited Outside Activities – 5 C.F.R. §5501.109 Summary of NIH-Specific Provisions in Interim Final Rule Prohibited Outside Activities – 5 C.F.R. §5501.109 What is allowed? In general, if otherwise approvable under existing regulations, the following activities are allowed: What is allowed? In general, if otherwise approvable under existing regulations, the following activities are allowed:

49. NIH employees who file public (SF 278) or confidential (OGE 450) financial disclosure reports are prohibited from acquiring or holding financial interests, such as stock, in biotechnology, pharmaceutical, and medical device companies and others involved in the research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. All other employees (that is, those who do not file either of these reports) are subject to a $15,000 cap on holdings in such companies. There is an exception from both rules for a financial interest, such as a pension or other employee benefit, arising from employment with a substantially affected organization and widely diversified, publicly traded mutual funds. NIH employees who file public (SF 278) or confidential (OGE 450) financial disclosure reports are prohibited from acquiring or holding financial interests, such as stock, in biotechnology, pharmaceutical, and medical device companies and others involved in the research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. All other employees (that is, those who do not file either of these reports) are subject to a $15,000 cap on holdings in such companies. There is an exception from both rules for a financial interest, such as a pension or other employee benefit, arising from employment with a substantially affected organization and widely diversified, publicly traded mutual funds. Summary of NIH-Specific Provisions in Interim Final Rule Holdings – 5 C.F.R. §5501.110

50. Senior employees may not receive gifts with an aggregate market value of more than $200 that are an award given because of their official position or from a prohibited source. Other employees having official responsibility for matters involving the donor (even if not personally involved) may not receive the gifts with an aggregate market value of more than $200 that are an award given from such a donor. Employees, generally, may receive awards from outside sources that are nothing more than plaques or trophies of little intrinsic value and free attendance and food at the event in which employee is honored. There is an exception to the ban that may permit the acceptance of gifts with a aggregate market value of more than $200 that are associated with the most prestigious awards that confer an exceptionally high honor in the fields of medicine or scientific research, e.g., Nobel, Lasker, if the award is otherwise approvable. Senior employees may not receive gifts with an aggregate market value of more than $200 that are an award given because of their official position or from a prohibited source. Other employees having official responsibility for matters involving the donor (even if not personally involved) may not receive the gifts with an aggregate market value of more than $200 that are an award given from such a donor. Employees, generally, may receive awards from outside sources that are nothing more than plaques or trophies of little intrinsic value and free attendance and food at the event in which employee is honored. There is an exception to the ban that may permit the acceptance of gifts with a aggregate market value of more than $200 that are associated with the most prestigious awards that confer an exceptionally high honor in the fields of medicine or scientific research, e.g., Nobel, Lasker, if the award is otherwise approvable. Summary of NIH-Specific Provisions in Interim Final Rule Awards – 5 C.F.R. §5501.111 Summary of NIH-Specific Provisions in Interim Final Rule Awards – 5 C.F.R. §5501.111