# Presentation: 657304

## Director’s Report to the

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

**     ****May 17, 2006**

## Slide 2

## Slide 3

## NIDA  BUDGET

**(Thousands)**

**Increase Over**** Prior Year**

**AIDS**

**TOTAL**

**NonAIDS**

**$693,282**

**$313,137**

**2005****Actual**

**$1,006,419**

**+1.2%**

**$699,956**

**$300,073**

**2006****Approp.**

**$1,000,029**

**-0.6%**

**2007****PB**

**$695,563**
**$299,266**
**$994,829**

**-0.5%**

## Slide 5

## FY 2007 Budget: 

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

**Notes:**
Good morning, Mr. Chairman and members of the Committee. 

Let me begin by thanking the Committee for your continuing support of the National Institutes of Health (NIH).  Through your unprecedented doubling of our budget, we have been able to support remarkable, life-saving research.  

 I will share some of our recent breakthroughs with you and discuss our strategic approach to dealing with the dual challenges: 
	deficit reduction 
	increasing health concerns.  

This past year at NIH has been a time of extraordinary collaboration, progress, and discovery that will help transform medicine in the 21st century.

## Cancer

**Survivorship**

- Millions of People

- 1971

- 1986

- 1990

- 2003

- 9

- 6

- 3

**Cancer**

- For the first time in recorded history, annual cancer deaths in the United States have fallen
- 10 million survivors
- Improved effectiveness of early detection and screening
- Thanks to the doubling, new targeted, minimally invasive treatments for cancer multiplied
- New drugs developed for cancer prevention

## NIH

**NIH**

*Transforming medicine through discovery*

## 33 Interviews for Radio, TV, and 

**Sharan Jayne**

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

## Recent NIDA Activities

**Recent NIDA Activities**

## NIDA Council Workgroups

**NIDA Council Workgroups**

## NIDA Basic Science Review Workgroup

**NIDA Council**

**Members**

**Linda Porrino, Ph.D, Chair**
**Barry Lester, Ph.D.**
**John P. Rice, Ph.D.**

**Frank Ivy Carroll, Ph.D**
**Yasmin Hurd, Ph.D.**
**Guy Cabral, Ph.D.**
**Stanley Watson, M.D., Ph.D.**
**Marina Picciotto, Ph.D.**
**Michael Nader, Ph.D.**
**Kathryn Cunningham, Ph.D.**

**Workgroup Report Will Be**
** ****Presented Today**

## NIDA’s Approach to Grant-Making Work Group

**Members**

**Scott Lucas, Ph.D.**
**Kathleen Carroll, Ph.D.**
**Tom Kosten, M.D.**

**NIDA’s Approach to Grant-Making Work Group**

**NIDA Council**

**Constance Weisner, Dr.P.H., M.S.W.**
**    ****Chair**
**David Vlahov, Ph.D.**
**Claire E. Sterk, Ph.D.**
**Mark Greenberg, Ph.D.**
**Rodolfo Arredondo, Jr., Ed.D.**
**Linda Porrino, Ph.D.**

## Social Neuroscience (RFA-DA-06-004)

**Social Neuroscience (RFA-DA-06-004)**

**Released November 10, 2005 receipt Date: February 23, 2006**
**61 Applications**

**Prescription Opioid Use and Abuse in the Treatment of Pain (RFA-DA-06-005)**

**Released November 18, 2005 Receipt Date: February 23, 2006**
**89 Applications**

**Epigenetics of Addiction (RFA-DA-06-007)**

**Released October 2, 2005 Receipt Date: January 23, 2006**
**43 Applications**

## New NIDA PAs and RFAs 

**Cutting-Edge Basic Research Awards (****CEBRA****) **
**(R21) (PAR-06-209)**
**Drug Abuse Aspects of ****HIV/AIDS**** and Other Infections **
**(R21) (PA-06-309); (R03) (PA-06-310)**
**Behavioral Science Track Award for ****Rapid Transition**** (B/START) **
**(R03) (PA-06-300)**
**Imaging-Science Track Award for ****Rapid Transition**** (I/START) **
**(R03) (PA-06-311)**
**Drug Abuse ****Prevention**** Intervention Research **
**(R21) (PA-06-317); (R03) (PA-06-318)**
**Inhalant Abuse****: Supporting Broad-Based Research Approaches **
**(R21) (PA-06-327); (R03) (PA-06-328)**
**Women, ****Sex/Gender**** Differences and Drug Abuse**
** ****(R21) (PA-06-331); (R03) (PA-06-332)**
**Epidemiology**** of Drug Abuse **
**(R21) (PA-06-329); (R03) (PA-06-330)**
**Prescription**** Drug Abuse **
**(R21) (PA-06-339); (R03) (PA-06-340) **

## PAs and RFAs Issued

**With Other NIH Components/Agencies**

***Foci include:***
** ****Development**
** ****Genetics**
** ****HIV/AIDS**
** ****Health Services**
** ****Health Disparities**
** ****Translational **
**     ****Research**

**43 New PAs and 1 New RFA**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience & **
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**HIV/AIDS Research**

## HIV Screening as Cost-Effective as Screening for Colon Cancer and Other Conditions

***How can this apply to CJ and other at-risk populations?***

***Paltiel, et al. and Sanders et al., NEJM 352(6), 2005.***

## The Challenge Now Is to 

**Change the Culture...**
**to Increase Willingness To Accept**
**More Widespread Testing**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience &**
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DPMCDA**

## Outpatient Study:  Percent of Negative Urines 

**After Depot Naltrexone Administration**

**0%**

**10%**

**20%**

**30%**

**40%**

**50%**

**60%**

**70%**

**80%**

**0**

**2**

**4**

**6**

**8**

**10**

**12**

**14**

**16**

**18**

**Visits (2 per week)**

**Comer, S. D., Sullivan, M. A., Yu, E., Rothenberg, J. L., Kleber, H. D., Kampman, K. et al. *****Arch Gen Psychiatry, 63,***** 210-218, 2006.**

**Notes:**
Retention in treatment was dose related, with 39%, 60%, and 68% of patients in the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively, remaining in treatment at the end of 2 months. Time to dropout had a significant main effect of dose, with mean time to dropout of 27, 36, and 48 days for the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively. The percentage of urine samples negative for opioids, methadone, cocaine, benzodiazepines, and amphetamine varied significantly as a function of dose. 

## Advantages of Depot Naltrexone

**Can be administered once a month**
**Can be used in the prison system and the **
**    ****criminal justice system...ensuring adherence**
**    ****to treatment**
**Can be “exported” to countries that have opiate abuse problems but don’t allow agonist therapy- Russia, Egypt**
**May help to reduce HIV incidence resulting from i.v. drug abuse **

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience &**
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DESPR**

## Criminal Justice Drug Abuse Treatment Studies(CJ-DATS)

**Criminal Justice Drug Abuse Treatment Studies****(CJ-DATS)**

***To improve outcomes for offenders with substance use disorders through effective integration of drug abuse treatment, ***
***public health, & public safety systems ***

**Notes:**
CJ-DATS – 
10 sites, 
1 coordinating center, 
2 of 10 sites focused on adolescents in the juvenile justice system.  
Researchers are partnered with many criminal justice systems in states throughout the country.

## CJ System Replete with Addiction: Access to Medications is Needed

**C = Counseling Only; **
**C+T = Counseling & Treatment Referral; **
**C+M = Counseling & Methadone Started in Prison**

**Maryland Prison Study: Treatment Linkage and Opiate-Free **
**One Month Post Release (N=100)**

***Preliminary Analysis:  Tim Kinlock, et al., 2006***

**CJ System Replete with Addiction: *****Access to Medications is Needed***

**C vs. C+M p < .05**

**In Treatment**

**C vs. C+T and C+M p < .01**

**Urine Test Positive**

**Notes:**
The data are from the first 100 participants in the Prison Methadone study.
The proportions of participants in treatment at 1-month post-release are:
-Counseling only, 9%
-Counseling+ Transfer, 42%
-Counseling + Methadone, 65% 
Chi-square goodness-of-fit tests found that there were significant differences between Counseling Only and Counseling+Methadone (p<.001) and Counseling+Transfer (p<.01).
The proportion of participants testing positive for opiates are:
-Counseling only, 76%
-Counseling + Transfer, 50%
-Counseling + Methadone, 34%
Chi-square goodness-of-fit tests found significant differences between Counseling Only and Counseling + Methadone (p<.05). 

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience &**
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DBNBR**

## Bullseye

** ****81 SNPs show the most difference among the cases and controls**

- 6 Million Common SNPs in Genome

**Whole Genome-wide Association Study  **
**Targeting Nicotine Dependence**

## Initial p values of Top 40 K SNPs

**Chromosome**

**Non-coding SNP**

**Coding SNP**

***Observed:***
**81 SNPs at 10****-4**

***Expected:***
**44 SNPs at 10****-4**

## MANY OF THESE GENES HAVE SYNAPTIC FUNCTIONS

***Dean and Dresbach, TINS, 2006***

**      ****CELL **
**ADHESION**

**      ****NEURO-**
**TRANSMISSION**

**         ****SIGNAL **
**TRANSDUCTION**

**TRANSCRIPTION ****       FACTORS**

**MANY OF THESE GENES HAVE SYNAPTIC FUNCTIONS**

**Notes:**
Functionally many of these genes are involved in  synaptic formation and cell signaling as shown here for example neurexin found with both Perlegen and IRP a presynaptic cell adhesion protein that binds with a postsynaptic protein neroligin which is involved in synaptic formation . While the other genes discovered are involved in modulating neurotransmission, signal transduction and gene transcription. 

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience &**
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DCNBR**

## Using Brain Imaging Technology

**   ****fMRI used to determine **
**     ****Coke vs. Pepsi preference**
**   ****fMRI used to determine **
**     ****preference for **
**     ****Super Bowl commercials**
**   **

***...******to better communicate ***
***with adolescents***

**McClure *****et al.,***** 2004**

**Iacoboni *****et al.,***** 2006**

**Notes:**
In their study, the researchers first determined the Coke versus Pepsi preference of 67 volunteer subjects, both by asking them and by subjecting them to blind taste tests. They then gave the subjects sips of one drink or the other as they scanned the subjects' brains using functional magnetic resonance imaging (fMRI). In this widely used imaging technique, harmless magnetic fields and radio signals are used to measure blood flow in regions of the brain, with such flow indicating brain activity levels. In the experiments, the sips were preceded by either "anonymous" cues of flashes of light or pictures of a Coke or Pepsi can. 
The experimental design enabled the researchers to discover the specific brain regions activated when the subjects used only taste information versus when they also had brand identification. While the researchers found no influence of brand knowledge for Pepsi, they found a dramatic effect of the Coke label on behavioral preference. The brand knowledge of Coke both influenced their preference and activated brain areas including the "dorsolateral prefrontal cortex" and the hippocampus. Both of these areas are implicated in modifying behavior based on emotion and affect. In particular, wrote the researchers, their findings suggest "that the hippocampus may participate in recalling cultural information that biases preference judgments." 
The researchers concluded that their findings indicate that two separate brain systems--one involving taste and one recalling cultural influence--in the prefrontal cortex interact to determine preferences. 

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**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**

** ****Division of Clinical**
**Neuroscience &**
**Behavioral Research**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**CCTN**

## Research Utilization  

**Research Utilization  **

***An Example with Adoption of Buprenorphine***

**Source: Roman et al Presented 2006**

***An Example with Adoption of Motivation Incentive***

**Notes:**
	CTPs that participated in the buprenorphine trials were significantly more likely to have adopted buprenorphine than CTPs not in the trials and non-CTN centers

## NIH Roadmap

**ACCELERATING MEDICAL DISCOVERY TO IMPROVE HEALTH**

**NIDA FY 2004 Roadmap Awards (NIDA’s FY04 Contribution: $3.4M)**
**                                                                                     ****Year 1              Year 2  **
**-    ****7 Grants Awarded to NIDA Researchers:       $2,065,403       $3,139,055**
**-    ****15 Grants Related to NIDA’s Research:         **_**$2,490,070**_**       **_**$2,547,116**_
**-    ****Total Amount of 1****st**** and 2****nd**** Year Awards:      $4,555,473       $5,686,171**

**NIDA FY 2005 Roadmap Awards (NIDA’s FY05 Contribution: $6.36M)**
**                                                                                      ****Year 1**
**-    ****8 Grants Awarded to NIDA Researchers:     $   1,516,243   **
**-    ****16 Grants Related to NIDA’s Research:        **_**$ 14,591,510 **_
**-    ****Total Amount of First Year Awards:             $ 16,152,753 **

## Recent and Upcoming Meetings,

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

## Recent NIDA Sponsored Meetings

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

**Recent NIDA Sponsored Meetings**

## PRISM AWARDS

**10****th**** Annual **
***PRISM AWARDS***

**April 27, 2006**

## Slide 38

## Slide 39

## Preventing Drug Abuse: 

**Preventing Drug Abuse: **
**A Developmental Science**

- A Congressional Briefing Sponsored by

**The *****FRIENDS OF NIDA***

**Monday, June 12, 2006**
**Noon - 2:00 pm**
**(Lunch will be served)**
**Rayburn House Office Building Room 2168 (Gold Room)**

## BLENDING

**BLENDING**

## Slide 42

## Advantages

**May be prescribed in physician’s offices or OTPs**
**Better safety profile than full agonists**
**Less likelihood of overdose**
**Lower abuse potential / lower diversion**
**Easier to stop:  If withdrawal occurs, it’s mild to moderate**
**Candidate for initial opiate for narcotic addiction therapy**
**Might be used as a transition to antagonist or drug-free therapy**