Directors Report to the

1
Directors Report to the National Advisory
Council on Drug Abuse
May 16, 2007
2
(No Transcript)
3
NIDA BUDGET
(Thousands)
2007C.R.
2008P.B.
2005Actual
2006Actual
693,282
698,976
699,908 300,457 1,000,365 0.1
NonAIDS
699,349 300,073 999,422
313,137
299,882
AIDS
1,006,419
998,858
TOTAL
Increase Over Prior Year
1.2
-0.8
0.1
4
RPG Funding, Unsolicited and Solicited
Funding (in billions)
Research Projects are part of research grants,
limited to activity codes R01, R03, R15, R21,
R22, R23, R29, R33, R34, R35, R36, R37, R55, R56,
P01, P42, PN1, UC1, U01, U19 and DP1. No NLM
awards are considered to be research projects.
Solicited awards are responses to Requests for
Applications (RFAs).
5
Success Rates of Solicited and Unsolicited
Competing RPG Applications
Research Projects are part of research grants,
limited to activity codes R01, R03, R15, R21,
R22, R23, R29, R33, R34, R35, R36, R37, R55, R56,
P01, P42, PN1, UC1, U01, U19 and DP1. No NLM
awards are considered to be research projects.
Solicited awards are responses to Requests for
Applications (RFAs).
6
I/Cs are arrayed by percent of funding for new
RPGs spent for responses to program
announcements in FY 2006
7
NIDA Dashboard
New PIs
?
?
Collaborations
Medicinal Chemists -- Recruitment -- Training
?
8
FY 2008 Budget Hearings

• March 1, 2007 -- House Appropriations
  Subcommittee on Labor, HHS
• and Education Hearing on FY 2008 Presidents
  Budget Request for
• SAMHSA, NIDA, NIAAA and NIMH
• March 6, 2007 -- House Appropriations
  Subcommittee on Labor, HHS
• and Education Hearing on FY 2008 Presidents
  Budget Request for NIH

• March 19, 2007 Senate Appropriations
  Subcommittee on Labor, HHS
• and Education Hearing on FY 2008 Presidents
  Budget Request for NIH
• March 26, 2007 Senate Appropriations
  Subcommittee on Labor, HHS,
• and Education FY 2008 Budget for Mind, Brain
  and Behavioral Research

9
IC Directors Retreat May 17-18, 2007 Roadmap II
Strategic Planning Groups
Top 5 Topics
1) Microbiome 2) Protein Capture/Proteome
Tools 3) Phenotyping Services, Tools 4)
Inflammation 5) Epigenetics
a) Training/Careers b) Health Disparities c)
Science of Science d) Pharmacogenomics
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Epigenetic Mechanisms Regulate How Genetic
Information Is Expressed Across Development,
Tissue, Environment and Disease States
Citations for Epigenetics
4500
4000

• DNA Methylation silences gene
• Histone Modification methylation, acetylation,
  or phosphorylation
• Non coding RNA

3500
3000
2500
2000
1500
1000
500
0
1990
1992
1994
1996
1998
2000
2002
2004
2006
Epigenetics
Epigenetics Disease
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Epigenetic Marks Are Altered in Common Brain
Disorders Including Addiction
12
Timeline for Epigenetics Program
FY08
FY09
FY10
FY11
FY12
FY13
FY14
FY15
FY16
FY17
FY07
JUMPSTART

• International Consortium
• Standardization
• Reagents (Abs)

• 24 comprehensive reference epigenomes
• Cell/tissue variation assessed
• New Ab reagents for epigenomics
• Public resource (cells/tissue, data, tools)

RFA1
Mapping Centers
RFA2
RFA1
RFA2
RFA3
RFA4
RFA5
RM/IC Projects
Co-fund up to 15 IC-based programs
RFA3

• Establish/maintain public data resource (via
  NCBI)
• New tools for data integration, analysis, and
  viewing

TRANSITION to ICs
Data Management Center
RFA2
RFA4
RFA1
RFA3
RFA4
Technology Development
Develop/adapt new tools, application to RM and
IC projects
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NIDA
National Institute on Drug Abuse
Office of the Director
Nora D. Volkow, MD
Director
Director, AIDS Research
Director, AIDS Research
Special Populations Office
Timothy P. Condon, Ph.D.
Deputy Director
Donna M. Jones
Executive Officer (Acting)
Office of Extramural Affairs
Office of Planning Resource Management
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Donna M. Jones (Acting)
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
14
Success Rates for AIDS Extramural and Non-AIDS
Extramural
Percent
15
Strategies of NIDAs Investment on AIDS
FY06 FY07 FY08 FY09 FY10
65M
60M
60M
58M
40M
Uncommitted Funds

• NIDA Staff Meetings
• to identify priority areas
• March 12, 2007
• April 9, 2007
• Scientific Meeting of
• Experts
• May 8-9, 2007

16
Changing Nature of the HIV Epidemic
17
HIV/AIDS Mechanisms

• Infrastructure
• facilitate access to existing cohorts (ALIVE,
  MLS)
• proteomic analysis
• animal models
• Innovative research
• Avant-Garde Award (equivalent to Pioneer
  Award)
• International
• Create clinical and basic research networks
• Training e.g., Invest Fellows/China/CTN
• Integrate research with NIAID international
  networks

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NIDA
National Institute on Drug Abuse
Director, AIDS Research
Special Populations Office
Office of Extramural Affairs
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
DESPR
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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Convergence of HIV Seroprevalence Among Injecting
and Non-injecting Drug Users
Drug Treatment Program
Respondent-Driven Sampling
(n448 2004)
(n2121 2001-2004)
17
15
CI 12-21
13
CI 11-19
12
CI 12-15
CI 9-16
HIV Prevalence
Source Des Jarlais et al AIDS, 21 231-235, 2007.
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NIDA
National Institute on Drug Abuse
Director, AIDS Research
Special Populations Office
Office of Extramural Affairs
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
DCNBR
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
21
Sexual Drug Behavior Patterns HIV STD
Racial Disparities
National Longitudinal Longitudinal Study of
Adolescent Health. 18 to 26 years old
Caucasian (n6257)
AA (n2449)
35
30
25
20
Prevalence HIV /STD
15
10
5
0
Few partners, low ATOD
Binge drinking
THC use
Multiple partners
Sex money
IDU
MSM
Drug use
Young caucasians are at elevated HIV risk when
they engage in risky behaviors whereas young AA
are at high risk even when their behaviors are
normative.
Source Hallfors et al Am J Public Health. 2007
97125-32, 2007.
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NIDA
National Institute on Drug Abuse
Director, AIDS Research
Special Populations Office
Office of Extramural Affairs
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
DBNBR
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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Effects of Statins on the Interactions of
HIV-1-Infected T Cells with Neurons With and
Without ETOH on the Oxidative Stress Marker, Heat
Shock Protein 70 (Hsp70)
Ator, atorvastatin Simva, simvastatin
0.3 EtOH
Statins Protect Human Neurons against EtOH-
HIV Type 1-Induced Oxidative Stress In Vitro
Source Acheampong et al. J Virol. 811492-1501,
2007.
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NIDA
National Institute on Drug Abuse
Update from Dr. Betty Tai this morning
Director, AIDS Research
Special Populations Office
Office of Extramural Affairs
Office of Science Policy Communications
Center for the Clinical Trials Network
CCTN
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
25
HIV Rapid Test
Integrating HIV Rapid Testing and Counseling
into Drug Treatment

• 1,000,000 people in USA are infected with HIV
• 40,000 new cases each year
• 25 of persons with HIV are unaware they are
  infected
• ¼ of persons who test HIV fail to return to
  receive results
• CDC now recommends offering routine HIV testing
  to persons at risk for HIV

• FDA approved
• blood from a finger stick or oral fluid
• 20 minutes
• 12-15/kit
• can be done by counselors

26
NIDA
National Institute on Drug Abuse
Director, AIDS Research
Special Populations Office
Office of Extramural Affairs
Office of Science Policy Communications
Center for the Clinical Trials Network
Teresa Levitin, PhD
Timothy Condon, PhD
Betty Tai, PhD
Division of Epidemiology, Services Prevention
Research
Division of Pharmacotherapies Medical
Consequences of Drug Abuse
Division of Basic Neurosciences Behavior
Research
Intramural Research Program
Division of Clinical Neuroscience Behavioral
Research
DPMCDA
David Shurtleff, PhD
Frank Vocci, PhD
Wilson Compton, MD, MPE
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
27
Injectable Sustained-Release Naltrexone for
Opioid Dependence Treatment
Sustained release naltrexone produced a robust,
dose-related increase in treatment retention and
in drug-free urines in heroin dependent subjects
(n60) Source Comer et al., Arch Gen
Psychiatry. 63210-218, 2006.
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Brain Imaging Drug Use Prevention Messages
(R21) (RFA-DA-07-007) 16 Applications DCNBR and
DESPR
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Extinction and Pharmacotherapies for Drug
Addiction (R01--RFA-DA-07-010) -- 15
Applications (R03--RFA-DA-07-011) -- 12
Applications
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Development of Immunotherapeutic Products for
the Treatment of Methamphetamine Addiction
(U01) (RFA-DA-07-004) 5 Applications
31
Recent and Upcoming Meetings, Conferences and
Events
32
The Addiction Projects Audience is estimated to
be over 50 million impressionsand counting

• Including
• HBO Channels over 13 million viewers
• HBO on Demand nearly 1 million orders
• DVD more than 30,000 sold
• Companion Book over 7,000 sold
• Podcasts over 380,000 downloads
• Online hbo.com/addiction, AOL cable
  affiliate websites over 600,000
• video streams 2.9 million page views
• Local National Outreach Parties Screenings
  over 32,000 people attended
• TV Media Coverage 35 million viewers
  (including The Oprah Winfrey Show,
• Good Morning America, The View, Lou Dobbs,
  Larry King Live)

33
Timothy P. Condon, Ph.D. Deputy Director, NIDA
Gregory Brigham, Ph.D. CRO, Maryhaven
Dennis McCarty, Ph.D. Oregon Health Sciences
University
34
ACNP
American College of Neuropsychopharmacology Liais
on Committee
Opportunities and Impediments to Drug
Development for Alcoholism and Other Substance
Abuse The National Press Club Washington,
D.C. May 20, 2007
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(No Transcript)
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Abstinence Rates Following Behavioral Treatment
for Marijuana Dependence
Proportion of Clients Abstinent
Source Kadden, RM, Litt, MD, Kabela-Cormier, E
and Petry, NM, Addictive Behaviors, 32, pp.
1220-1236, 2007.
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NABI Biopharmaceuticals Recently Announced
Positive Results of Its Phase IIb Trial of
NicVax

• Double-blind, placebo-controlled and dose
  ranging study
• 2 antigen doses (200mcg and 400 mcg per
  injection) NicVAX
• (Nicotine Conjugate Vaccine)
• Patients who showed continuous abstinence
  between weeks 19-26 had
• significantly higher antibody levels than
  those who did not quit at both
• the beginning and at the end of the
  assessment period
• Among the top 30 of antibody responders
• who received the drug 24.6 showed
• continuous abstinence from smoking between
• weeks 19-26 compared to 13.0 of controls
• This Phase IIb trial is continuing after all
  patients received a booster
• at six months secondary endpoints will be
  assessed at 12 months

38
NIDA HIV/AIDS PAs, PAS/PARs RFAs 2005-2007
PA-07-349 AIDS-Science Track Award for Research
Transition (R03) PA-07-307 Drug Abuse Aspects of
HIV/AIDS (R01) PA-07-308 Drug Abuse Aspects of
HIV/AIDS (R03) PA-06-069 Health Disparities in
HIV/AIDS Focus on African Americans
(R01) PA-07-116 Health Disparities in HIV/AIDS
Focus on African Americans (R01) PA-07-289
Health Disparities in HIV/AIDS Focus on African
Americans (R21) PA-07-290 Health Disparities in
HIV/AIDS Focus on African Americans
(R03) PA-06-309 Drug Abuse Aspects of HIV/AIDS
and Other Infections (R21) PA-06-310 Drug Abuse
Aspects of HIV/AIDS and Other Infections (R03)
PAs
PAS-07-324 Drug Abuse, Risky Decision Making and
HIV/AIDS (R01) PAS-07-325 Drug Abuse, Risky
Decision Making and HIV/AIDS (R21) PAS-07-326
Drug Abuse, Risky Decision Making and HIV/AIDS
(R03) PAS-07-115 Non-Injection Drug Abuse and
HIV/AIDS (R01) PAS-07-261 Non-Injection Drug
Abuse and HIV/AIDS (R03) PAS-07-262
Non-Injection Drug Abuse and HIV/AIDS
(R21) PAS-06-064 Non-Injection Drug Abuse and
HIV/AIDS (R01)
PAS/PARs
RFA-DA-07-002 Mechanisms of Drug Abuse
Interactions with HIV Neuropathogenesis
(R01) RFA-DA-07-003 Mechanisms of Drug Abuse
Interactions with HIV Neuropathogenesis
(R21) RFA-DA-05-008 HIV and Drug Abuse
Interventions Among Pregnant Women in Drug Abuse
Treatment (R01, R03 and R21)
RFAs
39
HIV/AIDS Priority Areas
Prevention
Treatment
Epidemiology
Consequences
Testing Counseling
Modeling International
Link to Tx Youth/Women
Early detection
Testing Re-entry Drug Tx
Criminal Justice
co-infections Psych-comorb
Medications Re-entry Services
Infection rates
Children Women
Stigma, Microbicides Women, Youth
Access
Non-IDU
Health Disparities
Non-IDU Epigenetics International
Proteomics NeuroAIDS Models Cognit imp HIV/HCV
Adherence Neurobiology Risk Genetics Drug abuse
HIV Tx as HIV prevent. E health
Drug interactions Pharmacokinetics,
Pharmacogenomics
Vulnerability Progression
CTN, CJDATS, NIAID, CDC, ATN, WIHS, MACS
Collaboration