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U.S. Overdose Crisis: 52,404 Deaths in 2015 (33,091 from Prescription and Illicit Opioids) National Institute on Drug Abuse Bringing the full power of science to bear on drug abuse and addiction Nora D. Volkow, M.D. Director National Institute on Drug Abuse Science = Solutions Wilson M. Compton, M.D., M.P.E. Advancing Addiction Science Deputy Director National Institute on Drug Abuse Marked Geographic and Temporal Variation in Overdose Deaths : Estimated Age-adjusted Death Rates for Drug Poisoning by County 1999 2015 https://www.cdc.gov/nchs/data-visualization/drug-poisoning-mortality/ Increasing Prenatal Exposure Admissions for Newborn Withdrawal Syndromes (Number per 1000 Admissions) Source: Tolia VN, Patrick SW, et al. NEJM 2015;372:2118-2126 Science = Solutions HIV and Hepatitis C Outbreak Linked to Oxymorphone Injection Use in Indiana, 2015 Peters et al. New England Journal of Medicine 2016;375:229-239 Overdose Deaths Primarily from Opioids: Prescription Drugs, Heroin and Synthetics (i.e. Fentanyl and similar) Any Opioid Commonly Prescribed Opioids (natural and semi-synthetic opioids and methadone) Heroin Other Synthetic Opioids (e.g. fentanyl) ENVIRONMENTAL AVAILABILITY: Current Opioid Crisis Originated with Prescribing Increases 250 200 Opioid Prescriptions in MILLIONS Opioid prescriptions Tripled to MORE THAN 200 MILLION prescriptions in recent years 150 100 50 0 ECONOMICS: Heroin Increases Due to Lower Price and Greater Availability $3,500 "Retail" Price Per Pure Gram $3,000 $2,500 $2,000 $1,500 $1,000 $500 $- National Drug Control Strategy--Data Supplement 2014. https://www.whitehouse.gov/sites/default/files/ondcp/policy-and-research/ndcs_data_supplement_2014.pdf Increasing Deaths from Illicitly produced (and very potent) Synthetic Opioids: Fentanyl (and related chemicals) Laced-Heroin and Prescription Pills ECONOMICS: CHEAP Fentanyl Precursor Chemicals Opioid Priority Areas Advancing the practice of pain management Expanded availability and distribution of treatments for opioid overdoses (i.e. naloxone) Expanded access to treatment and recovery services Strengthening public health surveillance Supporting cutting edge research Opioid Education Resources for Medical Students, Resident Physicians & Faculty Medical schools have developed innovative curriculum resources about how to identify and treat patients with substance use disorders Web training on pain assessment and treatment Bringing NIDA research to clinical practice Archived NIDA CME Courses: Upcoming NIDA CME Course: Safe Prescribing for Pain Managing Pain Patients Who Abuse Rx Drugs Adolescent Substance Use (Prescription Opioid Module) Recent Declines in Opioid Prescriptions 70 60 Opioid MME in BILLIONS 50 40 30 20 10 0 Opioid Morphine Milligram Equivalents Prescribed Declined 23.1% from 3rd quarter 2010 to 2nd quarter 2016 RESEARCH TARGET: Safe, Effective Strategies for Pain Management Knowledge of Pain Pathways – New Biomarkers for Pain? New study assess glial role in human pain • Patients with low back pain (LBP) versus controls –Uses PET to detect levels of glial protein (TSPO) –Demonstrates role of glial activation in human pain –Possible biomarker –May suggest new treatments for chronic pain Loggia et al., Brain 2015;138. Science = Solutions New Target for Pain Control • Congenital analgesia: rare condition, individuals cannot feel pain –Mutation identified in gene that encodes for Nav1.7 – sodium channel that regulates pain-sensing neurons • Targeting Nav1.7 to produce analgesia –Several companies now have drugs in pipeline to block channel • Targeting complications –Understanding what happens when Nav1.7 is blocked Science = Solutions A Promising New Generation Of Pain Therapeutics: Biased Mu-Opioid Receptor Ligands Soergel DG, et al., Pain 2014. Manglik A, et al., Nature 2016. DeWire SM, et al., JPET 2013. Bohn LM, et al., Science 1999 Science = Solutions Predicting Addiction? Variant Common Type • OPRM1 encodes for the target of opioids • Can variants predict likelihood addiction? • OPRM1 variant – Affects receptor levels in brain – Associated with increased risk for addiction, overdose severity Hancock et al., Biol Psychiatry 2015; 78. Manini et al., J Med Toxicol 2013; 9. Peciña et al., Neuropsychopharmacology 2015; 40. Mapping the differences Direct Overdose Intervention Naloxone Distribution for opioid overdose victims. The potential for direct intervention to save lives. “Evzio” naloxone auto-injector APPROVED BY FDA, April 3, 2014 “Narcan Nasal Spray” naloxone APPROVED BY FDA, November 18, 2015 Science = Solutions Retail Pharmacy Prescriptions for Naloxone Increase Markedly 2016 25000 20000 15000 2015 2014 10000 5000 Sources: Jones CM, Lurie PG, Compton WM. Am J Public Health. 2016;106(4):689-690; IMS Health, published https://www.performance.gov/content/reduce-opioid-related-morbidity-and-mortality 2Q2016 1Q2016 4Q2015 3Q2015 2Q2015 1Q2015 4Q2014 3Q2014 2Q2014 1Q2014 4Q2013 3Q2013 2Q2013 1Q2013 4Q2012 3Q2012 2Q2012 1Q2012 4Q2011 3Q2011 2Q2011 1Q2011 4Q2010 3Q2010 0 2Q2010 • Outpatient prescribing of naloxone may complement community-based distribution and first responder access. 30000 1Q2010 • Retail prescriptions show an increase of 9520% from the 4th quarter of 2013 to 2nd quarter 2016. 35000 Science = Solutions Overdose Treatment Research: 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 Medications Are Effective Medication Assisted Treatment (MAT) DECREASES: • Opioid use • Opioid-related overdose deaths • Criminal activity • Infectious disease transmission And INCREASES • Social functioning • Retention in treatment Kakko J et al., The Lancet 2003. Medications are Underused In 48 states and D.C., Opioid Abuse and Dependence Rates Exceed Buprenorphine Treatment Capacity In 2014, only 25% of opioid admissions had treatment plans that included receiving medications. 75% 25% Jones C et al., Am J Public Health 2015. MAT No MAT Treatment Episode Data Set (TEDS): 2004-2014. Science Driven Solutions: Improving Addiction Treatment Recent Advances: Advancing Addiction Science • Probuphine: buprenorphine implant; releases sustained dose for up to 6 months (FDA Approval May 26, 2016) • Initiating buprenorphine treatment in the emergency department improves treatment engagement and reduces illicit opioid use • Extended release naltrexone initiated in criminal justice settings lowers relapse rates and overdoses Lee JD, et al., Addiction 2015;100:1005-1014 and New Eng J Med 2016;374:1232-1242 Non-Pharmacological Treatments for Addiction Transcranial Magnetic Stimulation (TMS) Transcranial Direct Current Simulation (tDCS) Salling and Martinez, 2016. Deep Brain Stimulation (DBS) Implanted electrodes emit electrical stimulation to targeted brain region NIH Opioid Research Initiative Using Research to End the Opioid Crisis PAIN MANAGEMENT Safe, effective, non-addictive strategies OPIOID ADDICTION TREATMENT New, innovative medications and technologies Nonpharmacological Treatments (e.g. TMS) Opioid Vaccines Biomarkers For Pain Non-Opioid Analgesics Respiratory Stimulation Devices OVERDOSE REVERSAL Interventions to reduce mortality and link to treatment Science = Solutions : Using Research to Improve HIV and Hepatitis C in Rural Areas NIH is partnering with the CDC, SAMHSA and the Appalachian Regional Commission (ARC) to conduct research to address increased opioid injection drug use and resulting overdose, HIV and Hepatitis C infection. –Improve understanding problem’s scope; contributing health trends –Identify resources, obstacles –Develop intervention approaches to address these health threats Science = Solutions : Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of SAMHSA Opioid STR Grants (RFA-DA-18-005) • 21st Century Cures Act authorized and $500 million appropriated FY2017 ($500 anticipated FY2018). • Opportunity for research on expanding MAT for OUD • FOA solicits rigorous research, in collaboration with Single State Agencies, on effectiveness of approaches to – expanding MAT in primary care – continuity of care for individuals with OUD – linking individuals treated with naloxone to OUD treatment • Phased projects: 1 year planning phase (R21), 3 year research research project phase (R33). $200K/$500K direct maximum. • Due date June 20, 2017 Science = Solutions Advancing Addiction Science www.drugabuse.gov