Director’s Report to the National Advisory Council on Drug Abuse

1. 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 Budget Update Policy Issues Recent NIDA Activities & Events

3. Budget Update

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

5. Policy Issues

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

7. 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

8. NACDA Bioethics Taskforce Immunotherapy Recommendations STAGE I STAGE II STAGE III Translate to the Clinic/ Evaluate Prophylactic Potential Implement/ Ascertain Impact Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches • 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 • Continued development • of these promising • medications • Research that results in • clinical trials • Preclinical studies of • vulnerable populations • Research on • behavioral consequences

9. NIDA Immunotherapy Program PRESENT ACTIONS FUTURE (LONG-TERM) ACTIONS FUTURE (LONGER-TERM) ACTIONS Translate to the Clinic/ Evaluate Prophylactic Potential Implement/ Ascertain Impact Develop/Establish Safe & Effective Immunotherapeutic & Depot Medication Approaches • 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 • 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 • 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

10. Recent NIDA Activities & Events

11. NIDA RFAs Just Issued • 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)

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

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

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

15. Office of AIDS Research FY 2006 President’s Budget NIDA Approved Initiatives • 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

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

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

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”

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

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

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

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

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

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

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

26. NIH MRI Study of Normal Brain Development 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

28. The National Institute for Drug Abuse 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

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

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

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

32. Completed CTN Trials • 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

33. Selected Research Findings • Short Term Bup/Nx Detoxification • High acceptability; many drug free clinics have already adopted • Motivational Interviewing • Improved retention for stimulant abusers entering treatment • 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. Future Research Plans • Randomized control trials of Bup/Nx in assessing liver function in opioid dependence treatment • Randomized control trial of OROS MPH in ADHD adolescent with Substance Abuse disorders • Randomized control trial of OROS MPH in ADHD adult smokers • Prescription Opioid Addiction Treatment (POAT)

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

36. 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 Hand-Off Meeting Blending Team Led by 3 ATTC members & 3 NIDA members Dissemination Products

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

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

39. Update on the Blue Ribbon Task Force Report NIDA has addressed all 6 goals and 24 recommendations of the Blue Ribbon Task Force. 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 • Fund research to understand widely used common practices that have not been studied: Progress made, effort ongoing • Encourage use of research designs that permit causal inferences: Progress made, effort ongoing

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

41. Future Directions:Key Research Questions What are the characteristics of interventions that can: • 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

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

43. 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 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 Life expectancy Increase in Life Expectancy Due to Screening (Yr) Incremental Cost-Effectiveness of Screening ($/quality-adjusted life year) Quality-adjusted life expectancy Costs and benefits to partners excluded Costs and benefits to partners included 30 40 50 60 70 80 90 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 AGE (Yr) Prevalence of Unidentified HIV (%) Source: Sanders, GD et al., NEJM 352(6), February 10, 2005.

44. NIDA-Sponsored/Chaired Symposia at the Annual Meeting of the American College of Neuropsychopharmacology • Substance Abuse in the 21st 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 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. 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: • 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

49. Summary of NIH-Specific Provisions in Interim Final Rule Holdings – 5 C.F.R. §5501.110 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.

50. Summary of NIH-Specific Provisions in Interim Final Rule Awards – 5 C.F.R. §5501.111 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.