Directors Report to the

1
Directors Report to the National Advisory
Council on Drug Abuse
February 16, 2005
2
Budget Update
Policy Issues
Recent NIDA Activities Events
3
(No Transcript)
4
NIDA BUDGET
(Thousands)
NonAIDS
AIDS
TOTAL
Increase Over Prior Year
5
(No Transcript)
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

• 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

• 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 Brai
n 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
Barry Hoffer, MD, PhD
Joseph Frascella, 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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
15
Office of AIDS Research FY 2006 Presidents
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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
17
NIDAs 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 200587 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
Barry Hoffer, MD, PhD
Joseph Frascella, 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
Barry Hoffer, MD, PhD
Joseph Frascella, 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
Barry Hoffer, MD, PhD
Joseph Frascella, 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
MRI Study of Normal Brain
Development(N500)

• 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
Barry Hoffer, MD, PhD
Joseph Frascella, 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
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
Barry Hoffer, MD, PhD
Joseph Frascella, 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 NIDAEnhancing 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 DirectionsKey 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
200,000 180,000 160,000 140,000 120,000 100,0
00 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

45
(No Transcript)
46
(No Transcript)
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.