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Director’s Report to the National Advisory Council on Drug Abuse
May 2, 2017 Nora D. Volkow, M.D., Director National Institute on Drug Abuse @NIDAnews
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Search for DPMC Director
NIDA Office of the Director Office of Diversity & Health Disparities AIDS Research Program Office of Translational Initiatives and Program Innovations International Program Office of Management Office of Science Policy & Communications Intramural Research Program Division of Extramural Research Center for the Clinical Trials Network Division of Therapeutics and Medical Consequences Division of Neuroscience and Behavior Division of Epidemiology, Services and Prevention Research Search for DPMC Director On Hold Federal Hiring Freeze Dr. Rita Valentino
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Director, Division of Neuroscience and Behavior
Rita Valentino, Ph.D. Director Stress Neurobiology Division, Dep Anesthesiology, at Children’s Hospital of Philadelphia Professor of Anesthesiology and Critical Care at the University of Pennsylvania School of Medicine Her research has focused on the effects of social stress throughout development, the impact of coping style on behavioral and cognitive health and on substance use and on sex differences in responses to stress
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Director’s Report to the National Advisory Council on Drug Abuse
Budget Update What’s HHS/NIH? Recent NIDA Activities & Events
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UPDATE? NIDA BUDGET FY 2017 FY 2015 FY 2016 FY 2017 AIDS TOTAL
(Thousands) FY 2017 PB FY 2015 Actuals FY 2016 Operating Plan FY 2017 Senate Markup UPDATE? NonAIDS $716,833 $298,862 $1,015,695 $756,306 $294,244 $1,050,550 $756,306 $294,244 $1,050,550 AIDS $1,103,032 TOTAL Currently under a C.R. until April 28, 2017
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President’s 2018 NIH Budget Request
House Hearing – May 17, 2017 Senate Hearing – June 22, 2017
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Director’s Report to the National Advisory Council on Drug Abuse
Budget Update What’s HHS/NIH? Recent NIDA Activities & Events
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Focus on Brain Circuits
Foster Innovation: Focus on Brain Circuits Goal: Elucidate circuit structure and function to understand: How the brain works How to manipulate circuits for improved function Discover what circuits cause brain disorders Goal: Make circuit abnormalities the basis of diagnostics, and normalization of circuit function the target of intervention Emphasize technology development FIRST FIVE YEARS Emphasize discovery driven science SECOND FIVE YEARS Molecular/Structural Pathology Circuit Dysfunction Neuro/Mental/Substance Abuse Functional Disability
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30 Funding Opportunities in FY2017
Four on cell phenotyping: Classifying human and non-human brain cells, building a mouse brain atlas, and establishing associated data centers Two on post-doctoral training and career enhancement Three on informatics infrastructure Two support SBIR and STTR One on ethical issues in human brain research and neurotechnologies Four on integrated, interdisciplinary research on circuit function Twelve FOA re-issued from FY 2016 Imaging and non-invasive neuro-modulation in humans, Tool and technology development across scales BRAIN Public-Private Partnership Program, build partnerships between investigators and manufacturers of novel neural stimulation and/or recording devices Pending passage of the FY17 budget, new awardees will be announced following May and September Councils
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Director’s Report to the National Advisory Council on Drug Abuse
Budget Update What’s HHS/NIH? Recent NIDA Activities & Events
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National Academy of Sciences Report
Released: January 12, 2017 PURPOSE: To provide a comprehensive review of the current evidence regarding the health effects of using cannabis and cannabis-derived products RECOMMENDATIONS: Address Research Gaps Improve Research Quality Improve Surveillance Capacity Address Research Barriers From Susan…Announce the NASEM Cannabis Report and a briefing that NASEM is having on their new cannabis report for multiple stakeholders (we have also invited them to present at the next Advisory Council meeting). The Stakeholder Engagement Meeting will be held on February 21, 2017 at the National Academy of Sciences building in Washington, DC. Stakeholder representatives and members of the committee will be given the opportunity to engage in discussions about the report’s recommendations and proposed opportunities to advance the cannabis research agenda. They are still working on the meeting’s agenda and the proposed list of invited speakers, but the meeting is expected to run from 10am-4pm (EST) and will be webcast.
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ABCD Update ABCD Study Announces Fast Track Data release - SPRING 2017
This inaugural data release contains unprocessed neuroimaging data from 2000 participants, aged 9-10 years old, as well as basic participant demographics (age, sex), including: High-resolution structural data (3D T1 - and T2-weighted scans) Advanced diffusion MRI (multiple b-values and directions) Resting State fMRI Task fMRI (Monetary Incentive Delay, Stop-Signal, and Emotional N-Back), along with raw E-Prime task files
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National Advisory Council on Drug Abuse (NACDA)
Tobacco Industry Funding Workgroup Teleconference held on April 10, 2017 Workgroup Members: Anne C. Andorn, M.D. Laura Bierut, M.D. H. Westley Clark, J.D., M.D. Arthur T. Dean, M.A. Marie Dyak Edward Nunes M.D. (not present) Robert G. Rancourt, J.D. NIDA Staff Members: Susan Weiss, Ph.D. Carol Alderson Katia Howlett, Ph.D., M.P.P., M.B.A. Mary Kautz, Ph.D. Phylicia Porter, M.P.H. Mark Swieter, Ph.D. Kevin Walton, Ph.D. Ivan Montoya, M.P.H., M.D. National Cancer Institute Staff: Mark Parascandola, Ph.D., M.P.H. Michele Bloch, M.D., Ph.D. (not present) NIDA sought guidance: Tobacco Industry Funding of Investigators: --recommend principles and guidelines for funding decisions involving applicants with financial support from tobacco industry Data Access and Data Repositories: --open access databases for studies such as PATH and ABCD
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1. Tobacco Industry Funding of Investigators:
Selected Recommendations The applicant’s affiliated institution (academic or not) should have a demonstrated independent infrastructure. Researchers who are funded by tobacco must assure NIDA that they have complete freedom to publish any results. NIDA should require that any grantee financially supported by tobacco refrain from mixing those funds with NIDA or NIH funding. 2. Data Access and Data Repositories Selected Workgroup Recommendations Open-access data sources may contain unlimited data (e.g., from surveys) and limited data (e.g., biospecimens); No precautions were recommended for tobacco companies accessing such data; however, NIDA could post a statement conveying expectations that data will be used to benefit public health. Biospecimens from tobacco industry supported research would be acceptable for our repositories, provided they were collected in an ethical manner (with IRB approval etc.) and appropriate consent.
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Opioid Prescriptions have started to Decrease but Opioids Fatalities are still Increasing
Opioid morphine milligram equivalents (MME) dispensed fell by over 15% from Opioid OD Deaths US, 2015 Overdose Deaths: 52,404 Any Drug 33,091 Any Opioid National Overdose Deaths—Number of Deaths from Benzodiazepines, with and without opioids. The benzodiazepines from 2002 to 2015, with the red line representing the number of benzodiazepine deaths that also involved opioids, and the purple line representing benzodiazepine deaths that did not involve opioids. From , benzodiazepine deaths involving opioids increased twice as much as those not involving opioids. Source: IMS Health, U.S. Outpatient Retail Setting
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Fentanyl Synthesis from NPP
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Using Research to End the Opioid Crisis
NIH OPIOID RESEARCH INITIATIVE Using Research to End the Opioid Crisis PAIN MANAGEMENT Safe, more effective strategies OPIOID ADDICTION TREATMENT New and innovative medications and technologies OVERDOSE REVERSAL Interventions to reduce mortality and link to treatment
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Safe, More Effective Strategies for Pain Management
Soergel DG et al., Pain 2014; 155(9):1829–1835. Biased Mu-Opioid Receptor Ligands: New Generation Of Pain Therapeutics Non-Opioid Analgesics Cannabinoids; Inflammatory mediators; Ion channel blockers Targeted Opioid Analgesics with reduced potential for addiction and overdose Biologics e.g. antibodies that bind to pain producing cytokines Non-pharmacological treatment Neural stimulation; Surgical interventions; Meditation
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NARCAN® Nasal Spray device
Intravenous User Friendly Naloxone NARCAN® Nasal Spray device $37.50 per 4mg Approved by FDA November 2015 Naloxone Px increased 3.5X in past year NARCAN® Nasal Spray is the most prescribed naloxone 900,000 NARCAN® Nasal Spray doses distributed since launch in 2/16 Overdose Treatment: Saving Lives for Future Recovery New stronger, longer acting formulations to address more potent opioids (e.g. fentanyl) Stimulation devices to prevent respiratory depression Overdose detection and alert technologies Post-overdose interventions to ensure engagement in treatment
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Innovative Opioid Addiction Treatments:
Fentanyl Vaccine 2016: First vaccine for fentanyl and fentanyl analogs reported in a mouse model Successfully stimulated antibody production Reduced fentanyl reaching the brain Reduced analgesia and protected against overdose Bremer et al, 2016; Janda and Treweek, 2012.
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The Case for a Public-Private Partnership on Development of Non-Addictive Pain Medicines
Urgent public health crisis Absence of highly potent alternatives to opioids – market failure? Emergence of numerous potential drug targets Possibility of development and validation of biomarkers for pain relief Strong support at the highest level of U.S. Government FDA participation will be critical Potential for additional industry incentives
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New NIDA FOAs Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants (R21/R33) RFA-DA Issued: April 10, 2017; Open Date: May 20, 2017; Application Due Date(s):June 20, 2017. Solicit applications proposing to test approaches for expanding MAT for OUD in the general health care sector or linking individuals with OUDs who receive naloxone for the reversal of overdose in the context of states’ plans for use of funds authorized under the 21st Century Cures Act.
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Priority Areas Prevention Research Treatment Interventions
(Children & Adolescents) genetics/epigenetics development environment co-morbidity Prevention Research Priority Areas (New Targets & New Strategies) Treatment Interventions
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Lofexidine In development by US WorldMeds for:
2nd Pivotal Study: SOWS-G Scores In development by US WorldMeds for: Mitigation of opioid withdrawal Facilitation opioid discontinuation treatment Supported by 2 NIDA collaborative grants R01 converted to U01 awarded in 2010 to support final clinical pharmacology/PK study requirements for registration GO-MED grant awarded in 2012 to support 2nd pivotal study and open label safety study Fast Track Designation awarded by FDA in 12/2016 Final Submission of NDA targeted 10/2017 Target Approval May 2018 Target Launch Q3 2018 SOWS Gossop : 2-4 points change is a clinically meaningful response
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Priority Areas Prevention Research Treatment Interventions
` (Children & Adolescents) genetics/epigenetics development environment co-morbidity Prevention Research Priority Areas Treatment Interventions HIV and Drugs Prevention Treatment (New Targets & New Strategies)
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2017 Avant-Garde Awards for HIV/AIDS Research
Michael Farzan, Ph.D., The Scripps Research Institute A safety switch for an effective HIV-1 vaccine Preclinical studies on gene therapies for prevention of HIV infection in high-risk populations, such as IDU. Eric M. Poeschla, Ph.D., University of Colorado Denver Novel Approaches to Innate Immunity Against HIV-1 and Other Viruses Will use animal and human cells to explore the use of viral RNA-dependent RNA polymerase (RdRP) to enhance innate immunity against HIV-1 and other viruses. Peter S. Kim, Ph.D., Stanford University Making the HIV-1 gp41 pocket amenable to small-molecule drug discovery Will employ a strategy that increases the structural rigidity in the HIV-1 gp41 region in order to test new therapeutics that target gp41 pocket to prevent HIV infection.
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New NIDA FOAs Advancing Exceptional Research on HIV/AIDS and Substance Abuse (R01) (RFA-DA ) Posted Date: March 3, 2017; Open Date (Earliest Submission Date) : July 22, 2017; Letter of Intent Due Date(s):July 22, 2017 Application Due Date(s): August 22, 2017; August 22, 2018; August 22, AIDS Application Due Date(s): August 22, 2017; August 22, 2018; August 22, 2019. Innovative research projects that have the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention and treatment of HIV/AIDS in SUD. Nexus with drug abuse has to be clearly described. Avant-Garde Award Program for HIV/AIDS and Drug Use Research (DP1) (RFA-DA ) Issued: March 7, 2017; Open Date: June 30, 2017; Application Due Date(s): July 31, 2017, July 31, 2018, July 31, 2019. Innovative, basic research that may lead to improved prevention, treatments and outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV.
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Recent Increases in Reported Number of Acute HCV Infections in USA, 2000–2013
IDU main source of HCV infection Currently IDU in USA Surge in HCV in young IDUs (18-25 years old) 75% of new heroin abusers transitioned from Rx opioids to heroin National Notifiable Diseases Surveillance System (NNDSS) Better access to effective treatments for OUD to Prevent HCV Buprenorphine, Methadone and Naltrexone
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Opioid Treatment Programs in the USA
MAT Prevents HCV 2012 N-SSATS Data, SAMHSA Opioid Treatment Programs in the USA Long- vs Short-Term Buprenorphine Injection Past 30 Days 100 90 80 70 60 50 40 30 20 10 Baseline Week 26 p<0.05 LT-MAT (48 weeks) ST-MAT (2 weeks) Metzger DS et al., J AIDS 2015. Risky Behavior Reduction Shared Needles Buprenophine Methadone Probuphine: 26 mm long, 2.5mm diameter Implantable Buprenorphine - Probuphine™ (6 months) Percent Rosenthal et al., Addiction 2013;105. BASELINE 24 Week Woody GE et al., JAIDS. 2014.
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Rosenthal et al., Addiction 2013;105.
Cascade of Chronic HCV Care in USA OUD Cascade of Care in USA Current estimates Treatment gap 90% goal Yehia BR et al., Plos One 2014; 9(7): e Cascade of HCV Care in NJ Heroin Users Probuphine: 26 mm long, 2.5mm diameter Implantable Buprenorphine - Probuphine™ (6 months) Williams AR, Nunes E, Olfson M. Health Affairs Blog, 2017 Rosenthal et al., Addiction 2013;105. Akyar et al.,. Emerg Infect Dis. 2016;22(5):
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NCHHSTP/CDC, & CSAT/SAMHSA
HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Epidemics in US: Building Systems for Prevention, Treatment & Control (UG3/UH3) RFA-DA NIDA, National Center for HIV/AIDS, Viral Hepatitis, STD &TB Prevention NCHHSTP/CDC, & CSAT/SAMHSA Two stage, multi-method research projects that inform community response and promote comprehensive, integrated approaches to prevent HIV and HCV infection, along with associated comorbidities, among IDU in rural US communities. Hepatitis C Virus (HCV) Advanced Molecular Detection in Support of Systems for Prevention, Treatment and Control of HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States (U24) RFA-DA NIDA and NCHHSTP/CDC Support a Center for HCV next-generation sequencing using Global Hepatitis Outbreak and Surveillance Technology (“GHOST”) in collaboration with CDC. The GHOST Center will support HCV next-generation sequencing activities of research projects funded by the companion RFA (RFA-DA ).
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April , Atlanta GA Educational Advisor
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DHHS Secretary Thomas E. Price, M.D.
Announced $485 million in grants for prevention and treatment of OUD as part of the 21st Century Cures Act, passed Dec 2016 Funds will be followed next year by another half-billion dollar based upon an HHS assessment where funds can be most successful. HHS's top five priorities in addressing the opioid epidemic are: • Expanding access to treatment and recovery services • Supporting use of opioid overdose reversal drugs • Improving public health surveillance of the epidemic • Supporting research on pain and addiction • Advancing best practices for pain management
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Premiers May 1, 2017 at 10 PM This documentary portrays an emotional description of opioid addiction through the eyes of families who have lost loved ones, or who are struggling to help family members NIDA has worked with HBO on this hour long documentary and has helped them build an online resource page to offer more information on MAT and evidenced based treatment
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The Case for a Public-Private Partnership on Development of Non-Addictive Pain Medicines
Urgent public health crisis Absence of highly potent alternatives to opioids – market failure? Emergence of numerous potential drug targets Possibility of development and validation of biomarkers for pain relief Strong support at the highest level of U.S. Government FDA participation will be critical Potential for additional industry incentives
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NIDA-Supported HCV Research
NIDA is the 2nd largest supporter of HCV research at NIH (behind NIAID): 60 projects, $27.1 M in FY2015 Types of projects supported: HIV and HCV comorbidity in IDUs Basic research: HIV and HCV pathogenesis and the human genome; neuronal effects; viral and drug interactions Implementation research: Integration models for care Criminal Justice: risk reduction; testing and linkage to care Gender studies: Brief interventions for rural, at-risk women; support for women in drug tx court; prenatal care for pregnant women with HCV
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New NIDA-Supported HCV Research
NIDA: 2nd largest NIH funder—60 projects, $27.1 M (FY2015) Interventions for rural, at-risk women; support for women in drug court; financial literacy & vocational training for at-risk women; tailored prenatal care for pregnant women Rapid HCV testing in care settings Utilization of case managers within a coordinated care framework Adaptation of HIV model of “treatment as prevention” Efficacy of direct acting antivirals in substance using populations
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Recent Congressional Activities
2/14/17 House Energy and Commerce Committee, Subcommittee on Oversight and Investigations staff briefing on fentanyl & related issues (Volkow) 3/9/17 Meeting with Rep. Evan Jenkins (R-WV) & doctors/researchers from his district to discuss neonatal abstinence syndrome (NAS) & related issues (Volkow) 3/21/17 Hearing on Fentanyl for the Energy and Commerce Subcommittee on Oversight and Investigation (Compton) 4/3/17 Meeting with Senator Shelley Moore Capito (R-WV) as part of a broader NIH tour to discuss opioid research issues (Volkow) 4/4/17 NIH Caucus/Act4NIH – hill briefing on opioids (Volkow) 4/4/17 GOP Doctors Caucus: Discussion with 12 members of this caucus on a full range of marijuana issues (Volkow) 4/6/17 APA/ASAM Hill briefing on opioids (Volkow) 4/17-20/17 National Rx/Heroin Summit: Opportunity to meet and discuss issues with Senator Ed Markey (D-MA); Representative Hal Rogers (R-KY); Representative Buddy Carter (R-GA); and Representative Patrick Meehan (R-PA) (Volkow)
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Program Components
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New NIDA FOAs NIDA Translational Avant-Garde Award for Development of
Medication to Treat Substance Use Disorders (UG3/UH3) (RFA-DA ) Posted Date: March 8, 2017; Open Date: June 25, 2017; Application Due Date(s): July ; July 25, 2018; July 25, 2019. Support outstanding basic and/or clinical researchers with the vision and expertise to translate research discoveries into medications for the treatment of SUD from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U01) (PAR ) and (U19) (PAR ) (NIDA, NIMH & NIAAA) Posted Date: March 1, 2017; Open Date: May 23, 2017; Application Due Date(s): ): June 23, 2017… Advance discovery, preclinical development, and proof of concept testing of new, rationally based candidate agents and neuro-stimulation approaches to treat mental disorders, SUDs including alcohol addiction
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Priority Areas Prevention Research (Children & Adolescents)
genetics/epigenetics development environment co-morbidity Prevention Research Priority Areas
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New NIDA FOAs Functional Genetics, Epigenetics, and Non-coding RNAs in Substance Use Disorders (R01) (PA ) and (R21) (PA ) Posted Date: February 8, 2017; Open Date (Earliest Submission Date) May 5, 2017/May 16, 2017. Encourages genetic and genomic research in: 1. functional validation to determine which candidate genes/variants/epigenetic/non-coding RNA features have a role in SUDs, and 2. detailed elucidation of molecular pathways and processes modulated by candidate genes/variants, particularly for genes with an unanticipated role in SUDs. Evaluating the NIDA Standardized Research E-Cigarette in Risk Reduction and Related Studies (U01) (PAR ) Posted Date: February 8, 2017; Open Date: March 24, 2017; Application Due Date(s): April 24, 2017; April 24, 2018; April 24, 2019. Accelerate research evaluating e-cigarettes as a potential means of reducing risks associated with combustible tobacco use.
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Open Date (Earliest Submission Date) May 5, 2017.
New NIDA FOAs Marijuana, Prescription Opioid, or Prescription Benzodiazepine Drug Use Among Older Adults (R01) (PA ); (R21) (PA ); and (R03) (PA ) (NIDA & NIA) Posted Date: March 7, 2017; Open Date (Earliest Submission Date) May 5, 2017. This initiative will focus on two distinct populations of older adults: individuals with earlier onset of drug use who are now entering this stage of adult development or individuals who initiate drug use after the age of 50.
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NIH BRAIN Investment Fiscal Year Actual Budget # New BRAIN Awards
Blueprint NCCIH NEI NIA NIAAA NIBIB NICHD NIDA NIDCD NIMH NINDS OBSSR OD ORWH Fiscal Year Actual Budget # New BRAIN Awards 21st Century Cures ACD WG Recommendation FY14 $46.1M 58 FY15 $85M 67 $100M FY16 $154M 108 $190M FY17 TBD $10M $300M FY18 $86M $400M FY19 $115M $500M EXECUTIVE SUMMARY SLIDE 1
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Increases Incidence of HCV Between 2006 and 2012
Partnership Between NIDA and Appalachian Regional Commission (ARC) Increases Incidence of HCV Between 2006 and 2012 Particularly in Rural Communities Fund grants to address Increased opioid IDU, OD, HIV and HCV One-year planning grants to: problem’s scope; contributing health trends Identify resources, obstacles 4 Grants Funded RFA-DA Probuphine: 26 mm long, 2.5mm diameter Implantable Buprenorphine - Probuphine™ (6 months) In FY2017 broadened program with ARC to include CDC & SAMHSA Rosenthal et al., Addiction 2013;105. Anil G. Suryaprasad et al. Clin Infect Dis
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21st Century Cures Act Enacted in December 2016; provides funding for biomedical research; streamlines the drug approval process ` Provisions related to mental health and substance use disorders include: Increasing Providers in Underserved Areas Pediatric Mental Health Care Eating Disorders Awareness, Training and Parity Community Resources Grants to Address Opioid Abuse--The Act authorizes $1 billion in federal grants to states for use in carrying out opioid abuse prevention and treatment programs HIPAA Clarifications Federal Leadership The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental Health Crisis Reform Act of 2016. Key provisions related to mental health and substance use disorders include: Mental Health Parity Guidance and Enforcement. The Secretaries of Health and Human Services, Labor and the Treasury, in consultation with the Inspectors General of such agencies, are directed to issue a compliance program guidance document, not later than 12 months following enactment of the Act, which must include illustrative, de-identified examples of compliance and non-compliance with existing mental health parity requirements. The Secretary of Health and Human Services must also produce an action plan for improved federal and state coordination related to enforcement of mental health parity and addiction equity requirements. Medicaid Clarification and Expansion. The federal Medicaid statute is clarified to permit same-day billing of mental health and primary care services furnished at the same facility and, effective January 1, 2019, expand coverage of children receiving Medicaid-covered inpatient psychiatric hospital services. Increasing Providers in Underserved Areas. Grants are authorized to encourage professionals, including medical residents and fellows, nurse practitioners, physician's assistants, health service psychologists and social workers, to provide mental health and substance use disorder services in underserved communities and a Minority Fellowship Program is created to increase the number of mental health and substance use disorders professionals providing services to ethnic minorities. Both will be administered by the Health Resources and Services Administration (HRSA). Pediatric Mental Health Care. HRSA grants are authorized for behavioral health integration in pediatric primary care, including pediatric mental health statewide or regional telehealth networks. Additionally, the Act requires that at least 10 percent of states' annual block grants of funding for mental health be used for early intervention programs. Eating Disorders Awareness, Training and Parity. The Secretary of Health and Human Services and the Secretary of Education are directed to provide training for health professionals and school personnel to identify eating disorders and intervene early. The Act also clarifies that residential treatment for eating disorders is included within the scope of mental health parity. Community Resources. A number of grants and pilot programs are authorized or reauthorized to address mental health and substance use disorders in the community, including crisis intervention team programs and de-escalation training for law enforcement and other first responders, a pilot federal mental health court program and expansion of treatment and transitional services for individuals with serious mental illness or substance use disorders. Grants to Address Opioid Abuse. The Act authorizes $1 billion in federal grants to states for use in carrying out opioid abuse prevention and treatment programs, including (1) improving state prescription drug monitoring programs; (2) implementing and evaluating prevention activities to identify effective strategies to prevent opioid abuse; (3) training health care practitioners in best practices for prescribing opioids, pain management, recognizing potential cases of substance abuse, referral of patients to treatment programs, and overdose prevention; (4) supporting access to health care services, including opioid treatment programs; and (5) other public health-related activities as the state deems appropriate. HIPAA Clarifications. In an effort to clarify permitted uses and disclosures of health information by health care professionals to facilitate communication with caregivers of adults with serious mental illness, the Act directs the Secretary of Health and Human Services to ensure that health care providers, professionals, patients and their families, and others involved in mental health or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate uses and disclosures of protected health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To this end, the Secretary is required to develop and disseminate model training programs and materials within one year of enactment of the Act. Further, the Secretary is directed to convene a group of stakeholders to determine the effect of federal regulations relating to confidentiality of alcohol and drug abuse patient records on patient care, health outcomes, and patient privacy, not more than one year after such regulations are updated (a final rule updating the 42 C.F.R. Part 2 confidentiality regulations was published on January 18, 2017 and will take effect February 17, 2017). Federal Leadership. New high-level federal positions are established, including an Assistant Secretary for Mental Health and Substance Use and a Chief Medical Officer for the Substance Abuse and Mental Health Services Administration. The authorities of the existing SAMHSA Administrator are transferred to the Assistant Secretary. The Act also establishes interdisciplinary working groups focused on improving the coordination and delivery of mental health services.
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Rosenthal et al., Addiction 2013;105.
We have tools: To treat patients with SUD who are HCV+ …But we have MAJOR CHALLENGES 1. Treating Substance Abusers with antivirals 2. Treating HCV+ Patients for Substance Abuse Probuphine: 26 mm long, 2.5mm diameter Implantable Buprenorphine - Probuphine™ (6 months) Rosenthal et al., Addiction 2013;105.
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Training/Dissemination?Theory
Scientific Stewardship: NIH BRAIN Investment Theory/Training/Dissemination Training/Dissemination?Theory * Scientific goals and overarching principles of the BRAIN 2025 report and the BRAIN Multi-Council Working Group (MCWG) continue to guide NIH funding decisions BRAIN MCWG assessed progress in Feb. 2017, recognized investments towards 65/74 short-term goals Total President Budget = $195M in FY17 *All FY17 information is an estimate, as we do not know the FY17 budget.
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Rosenthal et al., Addiction 2013;105.
Lessons Learned from HIV Prevention: Applying it to HCV Comprehensive approach is needed for addressing HCV, : Expanded and regular HCV testing Links to care & treatment for HCV with antivirals Access to treatment for SUD including expanded access of MAT Wide availability of needle and syringe programs MAT for IDU is a prevention strategy for HIV and HCV MAT improves adherence to ARV and outcomes for HIV and HCV MAT is still very restricted and its use should be expanded within the health care system and in criminal justice settings. Success in implementing MAT is necessary for achieving an AIDS free generation and for containing the growing HCV epidemic. Probuphine: 26 mm long, 2.5mm diameter Implantable Buprenorphine - Probuphine™ (6 months) Rosenthal et al., Addiction 2013;105. John W. Ward, M.D., CDC
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