director’s report to the national advisory council on drug ... · cpa, mba office of science...

Director’s Report to the National Advisory Council

on Drug Abuse May 7, 2014

Nora D. Volkow, M.D., Director

In Memoriam

RICHARD DENISCO, M.D. Division of Epidemiology, Prevention

and Services Research, NIDA

Led portfolio on clinical research on pain and opioid analgesics at NIDA NIH Centers of Excellence for the Education of Pain Pain Registry for Pain Consortium

Outstanding scientific leadership and mentoring: •  First woman Head of Laboratory at the Rockefeller University Hospital

•  Director of a NIDA P50 Center

•  Mentor of students and faculty from all over the world

•  Champion of the view that addiction is a brain disease

Seminal contributions to drug abuse and addiction research: •  Development of methadone

•  Pioneered research on the genetic etiology of drug abuse •  Led groundbreaking research on endogenous opioid system and addiction-immune system relationships

Major Accomplishments

ELIZABETH ROBERTSON PH.D. Chief, Prevention Research Branch – 1998-2011

Senior Advisor for Prevention Research--2011- Present

Retiring after 19 Years at NIDA

and selected to receive the

ALBERT AVILA, PH.D. Director

Office of Diversity and Health Disparities (ODHD)

and heading the

Society for Prevention Research’s (SPR) 2014 Presidential Award for outstanding contributions to

advancing the field of prevention science

NIDA Council Subcommittee Working Group on Diversity in the Extramural

Research Workforce charged with providing concrete recommendations to the

NIDA Director on effective strategies to increase the number of underrepresented scientists in

drug abuse research, and to increase the number of grant applications submitted and funded

from underrepresented minorities

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 Actuals

$692,663

$300,749

$993,411

2014 Enacted

713,877

300,714

$1,014,591

President Barack Obama has nominated Sylvia Mathews, Director of the Office of Management and Budget,

as her replacement

HHS Secretary Kathleen Sebelius Resigns…

Change in NIH Resubmission Policy April 17, 2014

•  Effective immediately, for application due dates after April 16, 2014: Following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date.

•  NIH will not assess the similarity of the science in new (A0) application to previously reviewed submissions.

•  New (A0) application does not allow an introduction or responses to previous reviews, NIH encourages applicants strengthen their submissions.

•  Policy described in NIH Guide Notice NOT-OD-14-074 and NIH Guide Notice NOT-OD-14-082.

Enhancing Reproducibility and Transparency of Research Findings

Development of Training Resources

§  NINDS working with IRP on training module in experimental design §  Basic module expected to be road-tested with IRP staff (trainees, fellows, and faculty) by summer of 2014 §  Film version expected to be completed by end of 2014

§  IRP working on TEDMED-like talks on data interpretation considerations for various experimental techniques

§  Talks expected to begin in summer of 2014

§  Potential NIH course/resources on experimental design; could be done through FAES and adapted for online use

§  Options being explored for implementation by end of 2014

IC Pilot Summary Pilot Focus Types of Efforts Being Developed

Evalua:on of scien:fic premise/grant applica:ons

New FOAs with addi.onal review criteria regarding scien.fic premise

Checklist/Repor:ng Guidelines Reviewer checklists regarding repor.ng standards/scien.fic rigor

Changes to Biosketch Biosketch pilot coordinated by the Office of Extramural Research

Approaches to reduce "perverse incen:ves" Exploring award op.ons with a longer period of support for inves.gators

Suppor:ng replica:on studies New FOAs or collabora.ons for replica.on studies, and exploring op.ons to assess (at the .me of applica.on) whether pre-‐clinical findings should be replicated

Training Developing materials for the new training module on research integrity

Other efforts PubMed Commons Pilot system, use of prize challenges to encourage reproducibility of results

Proposed NIDA Division

Office of Diversity & Health Disparities

Albert Avila, PhD

International Program Steven Gust, PhD

Office of Management

Glenda Conroy,, CPA, MBA

Office of Science Policy & Communications

Jack B. Stein, PhD

Center for the Clinical Trials

Network

Betty Tai, PhD

Intramural Research Program

Antonello Bonci, MD

Office of the Director Nora D. Volkow, MD

Director

Wilson M. Compton, MD Deputy Director

Susan R.B. Weiss, Ph.D.

Assoc. Dir for Scientific Affairs

Glenda Conroy, CPA, MBA Executive Officer

AIDS Research Program Jacques Normand, Ph.D.

Division of Clinical

Neuroscience &

Behavioral Research Joseph Frascella, PhD

Division of Basic Neuroscience

& Behavioral Research`

Joni Rutter, PhD

Division of Pharmacotherapies & Medical Consequences

of Drug Abuse

Phil Skolnick, PhD

Division of Epidemiology,

Services & Prevention Research Redonna Chandler, PhD

(acting)

Office of Translational Initiatives and Program

Innovations Elena Koustova, PhD, MBA

Office of Extramural

Affairs

Division of Extramural Research


Current Structure Office of Extramural Affairs •  Office of the Director •  Contracts Review

Branch •  Grants Review Branch •  Extramural Activities

Branch

Proposed Structure Division of Extramural Research • Office of the Director •  Contracts Review Branch and

Grants Review Branch combined into new Scientific Review Branch

• Grants Management Branch •  Extramural Activities Branch

Division of Extramural Research •  Extramural Program Activities

ü  FOA Development ü  Trans-NIH Program Coordination (e.g., CRAN and BRAIN) ü  Training Coordination ü  Extramural Policies ü  Receipt and Referral ü  National Advisory Council on Drug Abuse ü  Grants Management ü  Grants and Contract Review


Please send comments/questions to: [email protected]

Priority Areas

(New Targets & New Strategies)

HIV and Drugs

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

Treatment Interventions

Prevention Research

Prevention Treatment

Driving after Drug or Alcohol Use Associated With Violations

and Accidents in Past Year

*Heavy drinking = 5 or more drinks

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Received Ticket or Warning

Involved in an Accident

Marijuana Heavy drinking Both Neither

P<.05

P<.05

0%

5%

10%

15%

20%

25%

30%

35%

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Marijuana Alcohol Heavy Drinking Other Illicit

O’Malley PM and Johnston LD. American Journal of Public Health, November 2013.

11-Year Trends in Driving or Riding after Drug or Alcohol

Use in Past 2 Weeks

Schmidt., Environ Health Perspect. Oct 1, 2013; 121(10): A298–A303

Non-Genetic Inheritance: Transgenerational Effects of Environmental Exposures

Vassoler Neuroscience, Volume 264, 2014

1.5 mg/kg THC (or vehicle) injections i.p. , every 3 days

Ado

lesc

ence

Young adulthood

Offspring behavior

Raised by drug-naïve mothers

F1

Szutorisz H, et al., Neuropsychopharmacology 2014.

Transgenerational Epigenetic Inheritance from Drug Exposure

0

20

40

60

80

Active lever Inactive lever (FR5: 5 lever presses for 1 heroin infusion)

Num

ber o

f lev

er p

ress

es

Heroin

Striatal DA synthesis and apathy (AES-S score)(p<0.02) Bloomfield et al., Psychopharm 2014.

Reduced striatal DA synthesis capacity in cannabis users relative to controls

DA Imaging In Cannabis Abusers 18F DOPA

Stress-Induced DA Changes in Subjects at Risk for Schizophrenia with and Cannabis Use (CU)

11C PHNO

Mizrahi et al.,Neuropsychoph 2014.

New Prevention FOAs

Avenir Award Program for Genetics or Epigenetics of Substance Abuse (DP2) RFA-DA-15-006.

Early stage investigators who may lack preliminary data for an R01 grant, but who propose high impact research and creativity.

Issued: March 27, 2014; Open date: July 18, 2014 Application due date(s): August 18, 2014, August 18, 2015, August 18, 2016.

Effects of Cannabis Use and Cannabinoids on the Developing Brain (R21) PA-14-162, (R01) PA-14-163, (R03) PA-14-164.

Issued March 26, 2014; Open Date(s): May 5, 2014 (R01); May 16, 2014 (R21 and R03)

To institutions that propose to study the effects and functional consequences of on the developing brain, from pre-, peri-, post-natal development through young adulthood in animal models and humans.

Uber CRAN NIDA NIAAA NCI NICHD NIMH? NINDS? Other agencies (FDA, CDC)?

National Longitudinal Study of Neurodevelopmental Consequences of Substance Use (Uber CRAN)

•  Drug policy changes creates an urgency to understand effects of drugs (cannabinoids, alcohol nicotine) to the developing human brain. •  Study intends to

•  Assess the impact of sporadic vs regular drug use on the developing brain •  Explore gateway interactions •  Identify neurodevelopmental pathways that link adolescent SUD and mental illnesses •  Assess effect of multiple substances in combination

•  Large representative cohort (~ 10,000) youth followed over a 10-year period, beginning before drug use into early adulthood.

•  Outcome measures--substance use, academic achievement, IQ, cognition

•  Estimated to cost $30 million/year for 10 years.

Planned Strategy

•  Expert panel workshop (open to the public) to develop recommendations on best large-scale designs and measures to assess developmental effects of substance exposure (beginning prior to exposure) during childhood through adolescence (in human subjects) – May 27-28, 2014

•  An RFI to get input on proposed study design/measures June, July 2014 •  A revised design based on input from the RFI to be presented for further input at a satellite symposium at SfN

•  An FOA to be released early in 2015

National Longitudinal Study of Neurodevelopmental Consequences of Substance Use

Priority Areas


HIV and Drugs



Prevention Research


Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health

National Rx Drug Abuse Summit April 22, 2014

Realities of Rx Drug Abuse

Nora D. Volkow, M.D. Director

Abuse-Resistant Opioid Prodrug (i.e., Signature Therapeutics)

PAIN: Less Abusable Analgesics

OD: User Friendly Naloxone (nasal spray)

•  AntiOp, single-dose, disposable naloxone nasal spray that combines a nasal spray device with a stable, concentrated naloxone solution •  Investigational New Drug (IND) filed in 2012

•  Product could be on the market in about 18 months •  Lightlake Therapeutics, biopharmaceutical company conducting clinical trials with intranasal naloxone for binge eating disorder is applying it towards the treatment of opioid overdose •  Clinical trials began last fall

mHealth for Preventing OD

Wireless SENSORS

Respiration Oxymeter

Arrythmias

ALARM

Set up delivery Alert Patient

Alert Third Party

NALOXONE DELIVERY

Automatic

Patient Third party

Priority Areas


HIV and Drugs



Prevention Research


New HIV/AIDS FOAs Avenir Award Program for Research on Substance Abuse

and HIV/AIDS (DP2) RFA-DA-15-007.

Early stage researchers who may lack preliminary data required for an R01, but who propose high impact research and creativity.

Issued: April 4, 2014; Open date: October 12, 2014. Application due date(s): November 12, 2014, November 12, 2015, November 14, 2016.

AIDS application due date(s): November 12, 2014, November 12, 2015, November 14, 2016.

NIDA Avant-Garde Award Program for HIV/AIDS and Drug Use Research (DP1) RFA-DA-15-004.

Issued: February 13, 2014; Open date: June 29, 2014. Application due date(s): July 29, 2014, July 29, 2015, July 29, 2016.

New HIV/AIDS FOAs

Issued: February 5, 2014; Open date: June 30, 2014; Application Due Date July 31, 2014.

Advancing Exceptional Research on HIV/AIDS and Substance Abuse (R01) RFA-DA-15-005.

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

Prevention and Treatment of Substance Using Populations with or at Risk for HCV (R34) PA-14-135,

(R21) PA-14-136, (R01) PA-14-137 (with NIDDK)

Encourages research focused on prevention and treatment of Hepatitis C Virus (HCV) to reduce new infections and identify and treat existing infections more effectively.

Issued March 3, 2014; Open Date(s): May 5, 2014 (R01); May 16, 2014 (R21 and R34)

•  4/2/14 – Budget Hearing for the DEA, House Appropriations Committee, Subcommittee on Commerce, Science, Justice & Related Agencies; NIDA Director testified on the science of addiction. •  4/29/14 – Hearing on Heroin and Prescription Drug Abuse, held by the House Energy & Commerce Subcommittee on Oversight & Investigations; NIDA Director, SAMHSA, & CDC participated. •  5/14/14 - Hearing on the Causal Role Prescription Drug Abuse has had on the Increased Use of Heroin in the United States, held by the Senate Caucus on International Narcotics Control; NIDA Director, Acting Director ONDCP, Director SAMHSA, and CMO Phoenix House will testify. •  6/19/14 – Hearing on Marijuana held by the House Oversight and Government Reform Subcommittee on Government Operations; NIDA and FDA will testify.

NIDA Participation in Recent Congressional Hearings

NIDA’s Fourth National Drug Facts Week Reached Millions Nationwide!

Over 1,000 events in 50 states

•  Overlapping Neuronal Circuits in Addiction and Obesity

•  Advances in Addiction Research

•  Biological Approaches to Treat Substance Use Disorders

•  Cannabis Use and Youth Risk Assessment and Implications for Clinical Practice

•  Diagnostic and Assessment Considerations for the Treatment of Comorbid Opioid Addiction and Chronic Pain

•  The Role of Substance Use in Violence Against Self and Others: How Research Can Inform Clinical Understanding of Risk

•  Persistence and Desistance of Comorbid Drug Abuse and Psychiatric Disorders in Adolescence

NIDA-SPONSORED ACTIVITIES •  NIDA International Satellite Meeting

•  Grant-Writing and Career Development Workshop •  NIDA Blending Initiative will provide support for a session titled: “Addiction Treatment Research vs Usual Care: What are the Foreseeable Risks?” •  NIDA will be granting 20 CPDD travel awards to NIDA-supported NRSA trainees, NRSA fellows, and Minority Supplement recipients

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