Health Research and Development to Stem the Opioid Crisis: A National Roadmap

2018·1.4 MB·English

by  National Science and Technology Council

HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
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HEALTH RESEARCH A ND DEVELOPMENT
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TO STEM THE OPIOID CRISIS:

A NATIONAL ROADMAP

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A Report by the
FAST TRACK ACTION COMMITT EE ON HEALTH SCIENCE AND
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TECHNOLOGY RESPONSE TO THE OPIOID CRISIS
COMMITTEE ON SCIENCE
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of the
NATIONAL SCIENCE & TECHNOLOGY COUNCIL
October 2018
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
About the National Science and Technology Council
The National Science and Technology Council (NSTC) is the principal means by which the Executive Branch
coordinates science and technology policy across the diverse entities that make up the Federal research
and development enterprise. A primary objective of the NSTC is to ensure science and technology policy
decisions and programs are consistent with the President's stated goals. The NSTC prepares research and
development strategies that are coordinated across Federal agencies aimed at accomplishing multiple
national goals. The work of the NSTC is organized under committees that oversee subcommittees and
working groups focused on different aspects of science and technology. More information is available at
http://www.whitehouse.gov/ostp/nstc.
About the Office of Science and Technology Policy
The Office of Science and Technology Policy (OSTP) was established by the National Science and
Technology Policy, Organization, and Priorities Act of 1976 to provide the President and others within the
Executive Office of the President with advice on the scientific, engineering, and technological aspects of
Dthe economy, national security, homeland security, health, foreign relations, the environment, and the
technological recovery and use of resources, among other topics. OSTP leads interagency science and
technology policy coordination efforts, assists the Office of Management and Budget with an annual review
and analysis of Federal research and development in budgets, and serves as a source of scientific and
technological analysis and judgment for the President with respect to major policies, plans, and programs
of the Federal Government. More information is available at http://www.whitehouse.gov/ostp.
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About the FTAC on Health S&T Response to the Opioid Crisis
In December 2017, OSTP convened a Fast-Track Action Committee (FTAC) on Health Science and
Technology (S&T) Response to the Opioid Crisis (Opioid FTAC) under the NSTC Committee on Science. The
Opioid FTAC was chartered to facilitate coordination of health research and development (R&D) and
related S&T activities across ageAncies, and with other Administration initiatives, in support of the national
response to the opioid crisis; facilitate interagency sharing of opioid-related health R&D findings, standard-
based data and tools, and best practices; assess gaps in, and opportunities for strengthening, the R&D and
related S&T response to the opioid crisis; and identify opportunities to expedite promising and potentially
groundbreaking R&D and public health surveillance efforts to rapidly combat the crisis.
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About this Document
This Opioid FTAC Roadmap identifies R&D critical to addressing key gaps in knowledge and tools, and
opportunities to improve coordination of Federal R&D essential to combating the opioid crisis. It builds on
the recommendations in the report from the President’s Commission on Combating Drug Addiction and
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The Opioid Crisis, as well as recommendations from multiple other sources, including the National
Academies report on Pain Management and the Opioid Epidemic, the Interagency Pain Research
Coordinating Committee’s Federal Pain Research Strategy, the National Governors Association report on
Governor’s Recommendations for Federal Action to End the Nation’s Opioid Crisis, and the Surgeon General’s
report Facing Addiction in America.
Copyright Information
This document is a work of the United States Government and is in the public domain (see 17 U.S.C. §105).
Subject to the stipulations below, it may be distributed and copied with acknowledgment to OSTP.
Copyrights to graphics included in this document are reserved by the original copyright holders or their
assignees and are used here under the government’s license and by permission. Requests to use any
images must be made to the provider identified in the image credits or to OSTP if no provider is identified.
Published in the United States of America, 2018.
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
NATIONAL SCIENCE & TECHNOLOGY COUNCIL
Executive Director
Chair (Acting)
Chloé Kontos, National Science and
Ted Wackler, Deputy Chief of Staff and
Technology Council
Assistant Director, Office of Science and
Technology Policy
COMMITTEE ON SCIENCE
Co-Chairs OSTP Liaison
Francis S. Collins, Director, NIH Lloyd J. Whitman, Principal Assistant
Director, Physical Sciences and Engineering
France A. Córdova, Director, NSF
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Michael J. Kratsios, Deputy Assistant to the
President, OSTP
FAST TRACK ACTION COMMITTEE ON HEALTH SCIENCE AND TECHNOLOGY
RESPONSE TO THE OPIOID CRISIS
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Co-Chairs OSTP Liaison
Wilson M. Compton, NIH Jean Paul Chretien, OSTP
Fay Lomax Cook, NSF
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Members
Sara Brenner, OSTP Chanya Liv, OASH
Betty-Ann Bryce, USDA Emily Mok, OMB
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Michael Colston, DOD Jayne Morrow, NIST
Deborah Dowell, CDC Alicia Richmond Scott, OASH
Farnoosh Faezi-Marian, OMB Vanila Singh, OASH
Christopher Jones, SAMHSA CecelTia Spitznas, ONDCP
Jeremy Kinsman, DOT Douglas Throckmorton, FDA
Tara Kunkel, DOJ Gamunu Wijetunge, DOT
Audrey Kusiak, VA Stephanie Xu, OSTP
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Table of Contents
Abbreviations .......................................................................................................... v
Executive Summary ................................................................................................ vi
Introduction ............................................................................................................ 1
1. Biology and Chemistry of Pain and Opioid Addiction ........................................... 3
Goal Statement ....................................................................................................................................... 3
State of the Science ................................................................................................................................. 3
Research Gaps and Needs ....................................................................................................................... 4
2. Non-Biological Contributors to Opioid Addiction ................................................. 5
Goal Statement ....................................................................................................................................... 5
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State of the Science ................................................................................................................................. 5
Research Gaps and Needs ....................................................................................................................... 5
3. Pain Management ............................................................................................... 7
Goal Statement ....................................................................................................................................... 7
State of theR Science ................................................................................................................................. 7
Research Gaps and Needs ....................................................................................................................... 7
4. Prevention of Opioid Addiction ........................................................................... 9
Goal Statement ....................................................................................................................................... 9
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State of the Science ................................................................................................................................. 9
Research Gaps and Needs ....................................................................................................................... 9
5. Treatment of Opioid Addiction and Withdrawal .................................................. 11
Goal Statement ..................................................................................................................................... 11
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State of the Science ............................................................................................................................... 11
Research Gaps and Needs ..................................................................................................................... 12
6. Overdose Prevention and Recovery .................................................................... 14
Goal Statement ....................................................................T................................................................. 14
State of the Science ............................................................................................................................... 14
Research Gaps and Needs ..................................................................................................................... 15
7. Community Consequences of Opioid Addiction .................................................. 17
Goal Statement ..................................................................................................................................... 17
State of the Science ............................................................................................................................... 17
Research Gaps and Needs ..................................................................................................................... 18
8. Opportunities for Enhanced Coordination .......................................................... 20
Conclusion ............................................................................................................ 21
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Abbreviations
ASPE Assistant Secretary for Planning and Evaluation
CDC Centers for Disease Control and Prevention
DOD Department of Defense
DOJ Department of Justice
DOT Department of Transportation
EMS Emergency medical services
FTAC Fast-Track Action Committee
GDP Gross domestic product
GSA General Services Administration
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HHS Department of Health and Human Services Human
HIV immunodeficiency virus
NIH National Institutes of Health
NIST NaRtional Institute of Standards and Technology
NSF National Science Foundation
NSTC National Science and Technology Council
OASH Office of the Assistant Secretary for Health
A
OMB Office of Management and Budget
ONDCP Office of National Drug Control Policy
OSTP Office of Science and Technology Policy
PDMP Prescription Drug Monitoring ProgrFam
R&D Research and development
SAMHSA Substance Abuse and Mental Health Services Administration
S&T science and technology
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USDA Department of Agriculture
VA Department of Veterans Affairs
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Executive Summary
As the opioid crisis continues to devastate the United States and its communities, science and
technology have been recognized as key components of the U.S. approach to combat the crisis.
Achieving scientific breakthroughs and advancements to help resolve the opioid crisis requires a
Federal research portfolio that strategically supports basic, applied, and implementation science. In
December 2017, the Office of Science and Technology Policy (OSTP) convened a Fast-Track Action
Committee (FTAC) on Health Science and Technology Response to the Opioid Crisis (Opioid FTAC) under
the National Science and Technology Council (NSTC) Committee on Science. The Opioid FTAC was
charged with creating a Roadmap for health research and development (R&D), and related science and
technology (S&T), to support the President’s opioid response. This Roadmap achieves its purpose by
identifying (1) R&D critical to addressing key gaps in knowledge and tools, and (2) opportunities to
improve coordination of R&D essential to combating the opioid crisis.
To organize its efforts and the Roadmap, the Opioid FTAC identified seven areas of R&D: (1) the Biology
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and Chemistry of Opioid Addiction and Pain; (2) Non-Biological Contributors to Opioid Addiction; (3)
Pain Management; (4) Prevention of Opioid Addiction; (5) Treatment of Opioid Addiction and
Withdrawal; (6) Overdose Prevention and Recovery; and (7) Community Consequences of Opioid
Addiction. The research recommendations generated by the FTAC in each of these areas, as well as an
eighth section that includes recommendations on ways to enhance coordination, are summarized
below. R
Biology and Chemistry of Pain and Opioid Addiction
• Elucidate the mechanisms and pathways that underlie both opioid addiction and pain.
• Integrate various investigative approaches to better understand the full complexity of opioid
addiction and pain.
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• Develop novel models, methods, and tools to study the basic biology of opioid addiction and pain.
Non-Biological Contributors to Opioid Addiction
• Characterize and develop effective approaches to address stigma.
• Identify the sociocultural and socioeconomic factors that contribute to opioid misuse and
addiction to inform effective risk mitigatioFn strategies.
• Increase understanding of how geographic disparities influence the effectiveness of prevention
and treatment approaches.
• Investigate how gaps in public and professional knowledge contribute to opioid misuse in
patients.
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• Study the efficacy of policies designed to address the opioid crisis.
• Investigate the impact of clinical and coverage policies on pain management, opioid misuse, and
addiction.
Pain Management
• Understand the factors driving the transition from acute to chronic pain.
• Develop non-addictive alternatives to opioids for treatment of acute and chronic pain.
• Determine effective, evidence-based, non-opioid, and non-pharmacological therapies and
interventions for pain management.
• Develop and test models and clinical practice guidelines for integrated pain management.
• Study the risks and benefits of treating and managing childhood and adolescent pain with opioids
and develop and test alternative strategies.
• Develop advanced, objective tools to more accurately, reliably, and quantitative assess of pain.
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Prevention of Opioid Addiction
• Improve data collection and interoperability to track and assess the opioid crisis and response.
• Assess ways opioid marketing, packaging, and disposal are related to opioid misuse and
inappropriate access to prescription opioids.
• Test whether the long-term impact of early childhood and adolescent interventions reduce later
opioid misuse and use disorder.
• Determine the effectiveness of population-based interventions, such as national, multi-platform
media and awareness campaigns, to reduce demand for prescription and illicit opioids.
• Evaluate the effectiveness of clinical interventions to reduce unnecessary use and misuse of
prescription opioids.
• Identify strategies to improve real-time or near real-time use of interoperable and interconnected
databases and access to data—including prescription drug monitoring program data—to curb
overprescribing and misuse of opioids.
• Determine how to scale up and sustain preventive strategies locally.
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Treatment of Opioid Addiction and Withdrawal
• Determine the effectiveness of novel approaches in treating opioid addiction, including new
medications, vaccines, and devices as part of treatment.
• Conduct research to inform development of best practices and guidelines for opioid addiction
treatment in women who are or plan to become pregnant that considers risks and benefits to both
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the pregnant woman and the developing fetus.
• Develop smart technologies to deliver care, support recovery, and monitor the impacts of
pharmacological therapeutics.
• Conduct research to inform the development and effective implementation of clinical best
practices, guidelines, and standards for the treatment of opioid addiction.
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• Enhance access to care through innovative strategies.
• Assess the effectiveness of peer and faith-based recovery support services as a component of the
public health response.
• Determine how to integrate public health approaches into criminal justice settings.
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Overdose Prevention and Recovery
• Develop additional methods for preventing opioid overdose deaths, such as vaccines, devices, and
novel medications.
• Develop new tools and local capacity to detect, identify, and characterize novel synthetic opioids.
• Research communication strategies to enhance awareness of opioid overdose reversal medication
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in at-risk populations and clinical service providers.
• Identify and track trends in fatal and non-fatal opioid overdoses to inform distribution and
availability of appropriate products and services.
• Research appropriate access to, and delivery of, overdose reversal products and services.
• Conduct research to identify factors associated with successful and unsuccessful long-term
outcomes for people who have overdosed.
Community Consequences of Opioid Addiction
• More quickly and accurately assess opioid morbidity and mortality.
• Identify how public health resources can be effectively allocated with the goal of long-term
sustainability.
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
• Identify how existing public health system actions, services, and partnerships can be leveraged to
build resilience in communities impacted by the opioid crisis.
• Determine the efficacy of innovative and creative approaches to the opioid response that address
a community’s unique features and culture.
• Monitor the full impact of prenatal opioid exposure on infant health and child development.
• Examine the vulnerabilities of children residing with opioid-addicted caregivers, including
developmental delays and addiction trajectory.
• Evaluate the role of recovery community organizations in mitigating community consequences of
opioids, including faith-based recovery communities.
• Determine the fate and transport of opioid and opioid metabolites in the environment.
Opportunities for Enhanced Coordination
• Align related research funding opportunity announcements.
• Establish a Federal opioid crisis research community of practice.
D• Promote additional coordination of the public health community with law enforcement and other
justice systems working to address the opioid crisis.
These research recommendations are intended to serve as a guide that identifies opportunities for
strengthening, expanding, and further coordinating core research and development efforts to reduce
the adverse public health impact of opioids and maximize the public health benefit of Federal
investments. R
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Introduction
Opioid misuse, addiction, and overdose have reached crisis levels in the United States. In addition to
the misuse and abuse of prescription opioids, a dynamic illicit drug market is causing an increasing
number of deaths due to overdose, including deaths from novel compounds previously unknown to the
scientific community. From 1999 to 2016, the number of overdose deaths involving opioids increased
more than five-fold, from 8,050 deaths to 42,250 (Figure 1).1 Both prescription and illicit opioids (e.g.,
heroin) contributed to this increase, with deaths involving synthetic opioids spiking in the most recent
years, from 3,100 deaths in 2013 to over 19,400 in 2016.2 Prescription opioids have been the mainstay
of pain management for many of the 100 million adults with chronic pain.3 Safer treatment options are
needed to reduce our reliance on opioids for pain relief.
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Figure 1: Drug Overdose Deaths in the U.S. Involving Opioids, 1999 to 2016. Source: NCHS WONDER, National
Vital Statistics System, Mortality

1 https://www.cdc.gov/nchs/data/databriefs/db294.pdf
2 https://www.ncbi.nlm.nih.gov/pubmed/29715347
3 https://www.ncbi.nlm.nih.gov/pubmed/22553896
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HEALTH RESEARCH & DEVELOPMENT TO STEM THE OPIOID CRISIS: A FEDERAL ROADMAP
Other consequences of the opioid crisis include high rates of opioid addiction and,4 increasing
infectious disease transmission (such as Hepatitis, HIV, and bacterial infection) due to sharing of
injection paraphernalia, including needles.5,6 The impacts of the opioid crisis are not limited to users
themselves, but extend to their families and their communities. For example, in the United States in
2014, one infant is born every 15 minutes diagnosed with opioid withdrawal after being exposed to
opioids before birth; the rate of neonatal opioid abstinence syndrome has increased by 433% (1.5 to 8.0
per 1000 hospital births) from 2004 to 2014.7,8 A recent multi-state analysis of opioid use disorder among
delivery hospitalizations reported that from 1999–2014, the national prevalence of opioid use disorder
increased 333%, from 1.5 cases per 1,000 delivery hospitalizations to 6.5, an average annual increase of
0.4 per 1,000 delivery hospitalizations per year.9 These direct and indirect consequences of the opioid
crisis carry a substantial economic cost, estimated at $504 billion in 2015—2.8 percent of GDP—
according to the White House Council of Economic Advisers.10
The Trump Administration has taken decisive steps to combat the opioid crisis. In March 2017, President
DTrump established the President’s Commission on Combating Drug Addiction and the Opioid Crisis.11
In October 2017, the President directed the Department of Health and Human Services (HHS) to
consider whether to declare the opioid crisis a nationwide public health emergency.12 In March 2018,
the White House announced the President’s Initiative to Stop Opioid Abuse and Reduce Drug Supply
and Demand, which identifies research and development (R&D) as an integral component of the
comprehensive response to the crisis.13
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Achieving scientific breakthroughs and advancements to help resolve the opioid crisis requires a federal
research portfolio that strategically supports basic, applied, and implementation research. The FTAC
Report builds on the recommendations in the President’s Commission on Combating Drug Addiction
and The Opioid Crisis’ report14 as well as recommendations from multiple other sources, such as the
National Academies’ report oAn Pain Management and the Opioid Epidemic,15 the Interagency Pain
Research Coordinating Committee’s Federal Pain Research Strategy,16 the National Governors
Association’s report on Governor’s Recommendations for Federal Action to End the Nation’s Opioid

4 https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf
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5 https://www.ncbi.nlm.nih.gov/pubmed/27468059
6 https://www.ncbi.nlm.nih.gov/pubmed/25950251
7 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4520760/
8 https://www.ncbi.nlm.nih.gov/pubmed/29572288
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9 http://dx.doi.org/10.15585/mmwr.mm6731a1
10 https://www.whitehouse.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/
11 https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Final_Report_Draft_11-1-2017.pdf
12 https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-
address-national-opioid-crisis.html
13 https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-initiative-stop-opioid-abuse-
reduce-drug-supply-demand-2/
14 https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Final_Report_Draft_11-1-2017.pdf
15 https://www.nap.edu/catalog/24781/pain-management-and-the-opioid-epidemic-balancing-societal-and-
individual
16 https://iprcc.nih.gov/Federal-Pain-Research-Strategy/Overview
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