Director’s Report to the National Advisory Council

on Drug Abuse

May 8, 2013

Nora D. Volkow, M.D., Director

David Shurtleff, Ph.D. Deputy Director

National Center for Complementary

and Alternative Medicine (NCCAM)

National Institutes of Health

Teresa Levitin, Ph.D. Director, Office of Extramural Affairs

National Institute on Drug Abuse

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

• Budget Update

• Recent NIDA Activities & Events

• What’s New @ HHS/NIH?

NIDA BUDGET (Thousands)

AIDS

TOTAL

NonAIDS

2012 Actuals

$733,076

$319,292

$1,052,368

2013 Operating Level

$691,816

$300,749

$992,565

2014 PB

$739,326

$332,286

$1,071,612

SEQUESTRATION

• Under sequestration, NIH Institutes will likely reduce

the final FY2013 funding levels of non-competing

grants that have yet to be funded this year, and make

fewer awards towards competing grants).

• Regardless of the status of NIH’s appropriation, as long

as the sequestration is in effect NIH would likely not be

able to restore awards to the fully committed levels,

non-competing grants already funded in FY13 could be

restored above the level funded under the CR.

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

• Budget Update

• Recent NIDA Activities & Events

• What’s New @ HHS/NIH?

FICC Members

• David Shurtleff (NIDA)

• Susan Weiss (NIDA)

• Lorraine Gunzerath (NIAAA)

• Michele Bloch (NCI)

• Yvonne Hunt (NCI)

Leaders at NIAAA, NIDA, and NCI have formed a Functional Integration Steering Committee (FISC)

that will guide integration efforts undertaken by the Functional Integration Coordination Committee (FICC),

which consists of representatives from the three ICs.

The FICC, established in April 2013, is meeting regularly to coordinate: 1) development of an FI website 2) FY 14 FOA proposals 3) other short- and long-term plans for the FI (e.g., portfolio analysis, evaluation)

Recent Functional Integration FOAs

Prevention and Health Promotion Interventions to Prevent Alcohol and Other Drug Abuse and Associated Physical and Psychological Health

Problems in U.S. Military Personnel, Veterans and their Families (R01) RFA-DA-13-012 (R34) RFA-DA-13-013

Issued: January 30, 2013; Open Date: April 1, 2013; App. Due Date: May 1, 2013.

Research on Comparative Effectiveness and Implementation of HIV/AIDS and Alcohol Interventions

(R01) RFA-AA-13-003 (R21) RFA-AA-13-004 Issued: March 27, 2013; Letter of Intent Due Date: April 29, 2013; App. Due Date: May 29, 2013.

Mechanisms of Alcohol and Nicotine Co-Addiction (R21) PA-13-193 (R01) PA-13-194 which NIDA subsequently signed on to:

(NOT-DA-13-024); (NOT-DA-13-025) Issued: April 1, 2013; Open Date: September 16, 2013.

To accelerate research on health promotion and prevention interventions with foci on reducing the onset & progression of alcohol, tobacco, & other drug use & abuse and associated mental & physical health problems & on the promotion of health-enhancing behaviors

To advance knowledge of the effective implementation & comparative effectiveness of alcohol-focused interventions among HIV+ individuals

To study neurobiological & behavioral mechanisms contributing to alcohol & nicotine co-addiction

The purpose of this PA is to inform the scientific community of the pain research interests of the various Institutes and Centers (ICs) at the National Institutes of Health (NIH) and to stimulate and foster a wide range of basic, clinical, and translational studies on pain as they relate to the missions of these ICs.

Mechanisms, Models, Measurement, & Management

in Pain Research (R03) PA-13-117 (R01) PA-13-118

(R21) PA-13-119

Issued: February 15, 2013; Open date(s): May 16, 2013.

NIH Pain Consortium Activities

New Common Fund FOAs

NIH Director’s Biomedical Research Workforce Innovation Award: Broadening Experiences in Scientific Training (BEST)

(DP7) RFA-RM-12-022 Due date(s): 5/10/13

Planning Grants for the NIH Building Infrastructure Leading to Diversity (BUILD) Initiative (P20) RFA-RM-13-001 Due date(s): 5/10/13

Support bold & innovative approaches to broaden graduate & postdoctoral training, required for a robust biomedical, behavioral, social and clinical research enterprise; Collaborations with non-academic partners are encouraged.

Encourage institutions with expertise & innovative strategies for developing research & mentoring opportunities for undergraduate students from backgrounds underrepresented in the biomedical research workforce to submit planning grant applications for the NIH Building Infrastructure Leading to Diversity (BUILD) initiative.

Planning Grants for the NIH National Research Mentoring Network (NRMN) (P20) RFA-RM-13-002. Due date(s): 5/10/13

Encourage organizations with experience in the mentorship of individuals underrepresented in the biomedical research workforce to submit planning grant applications for the NIH National Research Mentoring Network (NRMN).

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

• Budget Update

• Recent NIDA Activities & Events

• What’s New @ HHS/NIH?

Substance Use Disorders and Molecular Regulation of

Brain Energy Utilization (R01) RFA-DA-14-005;

(R21) RFA-DA-14-006) Issued: May 3, 2013; Letter of Intent Due Date: July 15, 2013;

Application Due Date: August 15, 2013.

Will support projects investigating the interplay between molecular regulation of brain energy utilization and brain and/or behavioral changes resulting from chronic exposure to abused substances.

New NIDA FOAs

In 2011… • More than 107 million Americans had tried it at least once • An estimated 2.6 million Americans used it for

the first time (averaging about 7,200 new users/day) • The majority (57.7%) of the 2.6 million recent marijuana initiates were younger than age 18

Source: 2011 National Survey on Drug Use and Health, SAMHSA, 2012.

Marijuana is the Most Commonly Used Illicit Drug In the U.S. and in Many Other Countries Worldwide

0

5

10

15

20

25

30

35

40

91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12

Percentage of U.S. 12th Grade Students Reporting Past Month Use of

Cigarettes and Marijuana

SOURCE: University of Michigan, 2012 Monitoring the Future Study.

Cigarettes

Marijuana

NIDA announces the availability of administrative supplements to inform social, behavioral, and public health impacts of recent US marijuana legalization laws/policies.

Research on Marijuana Legalization in the US

(Admin Supp) P A-13-138

Open date(s): April 30, 2013. Application due date(s): May 31, 2013

NIDA Marijuana Portfolio Discussion May 23, 2013

NIDA’s Marijuana research portfolio will be discussed broadly—from basic

science through services and policy research. Discussion will focus on:

• Types of cannabis research currently being supporting/conducted

• The most urgent research questions

• What is needed to address these questions (FOAs, scientific meetings, etc.)

• Suggestions of other ICs/agencies/private sector groups to partner with

Priority Areas

(New Targets & New Strategies)

HIV and Drugs

(Children & Adolescents) genetics/epigenetics development environment co-morbidity

Treatment Interventions

Prevention Research

Prevention

Treatment

Long-Access To Cocaine Decreases Excitability of

Deep-Layer Cortical Neurons

Naive

0.0

1.0

2.0

3.0

4.0

5.0

Bas

elin

e f

irin

g fr

eq

. (H

z)

Naive Cocaine

Prelimbic Photostimulation Decreases Compulsive

Cocaine Seeking Only After Shock Sessions

0

4

8

12

16

0 200 400

Num

ber

of A

Ps

input (pA)

Naive

Sensitive

Resistant

Chen et al., Nature (2013)

Resistant

Priority Areas

(New Targets & New Strategies)

HIV and Drugs

(Children & Adolescents) genetics/epigenetics development environment co-morbidity

Treatment Interventions

Prevention Research

Prevention

Treatment

On Cocaine Self-Administration On Nicotine Self-Administration

Effects of Chronic Buspirone Treatment

Mello NK et al., Neuropsychopharmacology, 2013.

Comparison: Binding Potential (BPnd)

D3 D2 [11C]NNC-112 [11C]Raclopride [11C]PHNO D1

MRI

Baseline

PO 3mg/Kg

1 hr

PO

3mg/Kg 3 hr

MRI

Baseline

IM 0.5 mg/Kg

3 hr

PO 3 mg/Kg

3 hr

MRI

Baseline

IM 0.5 mg/Kg

3 hr

PO 3 mg/Kg

3 hr

CTN-0052: A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults with

Cocaine Dependence (BRAC)

• Pilot enrolled 62 participants at 6 sites. 8/2012 – 3/2013 • Study completes 7/2013; database lock 8/2013 • Results will inform design of full-scale clinical trial

• Aim: evaluate efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential tx who will enter outpatient tx on discharge

• Two-stages: a pilot study, followed by full-scale trial

• Randomization to receive buspirone or placebo for 15 weeks, with a follow-up visit in week 16

A Double Blind, Placebo Controlled Trial Of TV-1380 (A Bioengineered Esterase) In Cocaine Dependence

[Teva/NIDA]

Accelerated cocaine clearance

(3.5 mg/kg, i.v.) in male rats with tx with

Cocaine Hydrolase

Cocaine Hydrolase Engineered from

Human Butyrylcholinesterase (E) Blocks

Reinstatement of Drug Seeking in Rats

C=cocaine; A= Amphetamine S=Saline

Brimijoin et al., Neuropsychopharmacology. 2008

A Double Blind, Placebo Controlled Trial Of NEPICASTAT (Dβh Inhibitor) In Cocaine Dependence

[Biotie/NIDA]

Nepicastat attenuates cue-induced

reinstatement of cocaine seeking

Schroeder et al., Neuropsychopharmacology. 2013 Devoto et al., Addict Biol. 2013

Nepicastat increases DA in PFC

(but not in Nac)

New Treatment FOA

Medications Development Centers of Excellence Cooperative Program (U54) RFA-DA-14-004

Issued: April 26, 2013; Letter of Intent due date(s): July 15, 2013; application due date(s): August 15, 2013

Solicits Specialized Center Cooperative Agreement (U54) applications to provide support for Medications Development Centers of Excellence (MDCE) with emphasis on clinical research directed towards the identification, evaluation, and development of safe and effective medications and biologics for treatment of substance use disorders (SUDs).

Notice of Intent to Publish a Funding Opportunity Announcement

New Ways to Counteract Prescription Drug Diversion and Abuse

(Small Business Technology Transfer [STTR, R41/42],

Small Business Innovation Research [SBIR, R43/44])

Issued by the National Institute on Drug Abuse (NIDA) Notice Number: NOT-DA-13-019; NOT-DA-13-020

Release Date: 2 April 2013

Estimated Publication Date of Announcement: Summer 2013

First Estimated Application Due Date: Fall 2013

Earliest Estimated Award Date: Spring 2014

Earliest Estimated Start Date: Spring 2014

Priority Areas

(New Targets & New Strategies)

HIV and Drugs

(Children & Adolescents) genetics/epigenetics development environment co-morbidity

Treatment Interventions

Prevention Research

Prevention

Treatment

Advancing Exceptional Research Awardees FY13

Julio Montaner, M.D. Director, BC Centre for Excellence in HIV & AIDS

Seek and Treat for Optimal Prevention of HIV & AIDS

(STOP HIV & AIDS) in BC

Jerome Groopman, M.D. Professor of Medicine, Harvard Medical School

Novel Strategies to Antagonize Cocaine-Enhanced

HIV Pathobiology

Phillip Berman, Ph.D. Professor of Biomolecular Engineering, University of California, Santa Cruz

Enhanced Anti-HIV-1 Antibody Responses in

African American Women Seropositive for HCV

New HIV/AIDS FOA

Exceptional Research on HIV/AIDS (R01) RFA-DA-14-003. Issued: March 20, 2013; Open date: July 1, 2013.

Application due date(s): August 1, 2013,

Will support highly innovative R01 applications on HIV/AIDS and drug abuse and will complement the Avant-Garde Award Program for HIV/AIDS research.

Why Are PRESCRIPTION DRUGS Abused

… And What Can We Do About It?

Nora D. Volkow, M.D. Director

CLINTON HEALTH MATTERS INITIATIVE (CHMI) WORKS WITH PARTNERS

TO ADDRESS THE PREVALENCE OF PRESCRIPTION DRUG MISUSE

Military Personnel, Veterans & Their Families: How Substance Abuse Research is Effecting Positive Change

Organized and Sponsored by the Friends of NIDA and

Co-Sponsored by the Congressional Addiction, Treatment and Recovery Caucus

and the Congressional Caucus on Prescription Drug Abuse

March 11, 2013 -- Capitol Hill Briefing