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What Is Addiction?

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What Is Addiction? Methadone and Buprenorphine Maintenance: Effective Treatments for Opiate Addiction Mary Jeanne Kreek, M.D. Patrick E. and Beatrice M. Haggerty Professor Head of Laboratory The Laboratory of the Biology of Addictive Diseases The Rockefeller University Senior Physician The Rockefeller University Hospital June 11, 2019 International Conference on Opioids Boston, MA funded primarily by NIH-NIDA, NIH-NCRR and the Adelson Medical Research Foundation What is Addiction? Compulsive drug seeking behavior and drug self-administration, without regard to negative consequences to self or others. (adapted from WHO) “drug” = nicotine, alcohol – legal drugs prescription opiates, marijuana (cannabis) – medicines (?) heroin, cocaine – illegal drugs 2019 Natural History of Drug and Alcohol Abuse and Addictions relapse to addiction without pharmacotherapy 90% - opiate; Primary Possible Utility of Vaccines Medications Useful 60% - cocaine, alcohol Prevention and Selected Medications and Needed Initial Sporadic Regular Addiction Early Protracted Self-Administration Intermittent Use Withdrawal Abstinence of Drug of Abuse Use (abstinence) Progression sustain abstinence with no specific medications ADDICTION: Compulsive drug seeking behavior 10% - opiate; and drug self-administration, without regard to 40% - cocaine, alcohol negative consequences to self or others (adapted from WHO). Adapted from Kreek et al., Nature Reviews Drug Discovery, 1:710, 2002; 2019 1 Prevalence of Specific Drug Abuse and Vulnerability to Develop Addictions – 2019 National Household Survey and Related Surveys – 2007 – 2016 Heroin Use – ever ~ 5.2 million Heroin Addiction ~ 626,000 Illicit Use of Opiate Medication – ever ~ 37.1 million (i.e., 14.2% of the population 12 and over) Dependence on Opiate Medication ~ 2.1 million Opiate (heroin, fentanyl, other) Overdose Deaths ~ 72,300 (in 2017)* Cocaine Use – ever ~ 40.5 million Cocaine Addiction ~ 966,000 Alcohol Use – ever ~ 216 million Alcoholism ~ 14.5 million Marijuana Use – ever ~ 123 million Marijuana Daily Use ~ 4 million Development of Addiction After Self-Exposure to Specific Drugs Opiate Addiction ~ 1 in 5 to 1 in 15 (20% to 6.5%) Alcoholism, Marijuana, and Cocaine Dependency ~ 1 in 8 to 1 in 15 (12.5% to 6.5%) SAMHSA Nat’l Survey on Drug Use and Health, 2017; Others, 2007-18; *Nat’l Center for Health Statistics (CDC), 2019 • Drug overdoses, primarily opioids, killed more than 72,300 Americans in 2017, a record and a rise of approximately 10% over 2016 • Drug overdose deaths in 2017 were higher than the peak yearly deaths from HIV, car accidents, or gun Overdose Deaths in Thousands in Preceding 12 months deaths 30 thousand Synthetic opioids • Overdose deaths have begun to fall in Massachusetts, Vermont, and Rhode 20 Heroin Island following major Other public health opioids campaigns, including Cocaine increased access to 10 treatment, in response Other Psychostimulants to the early arrival of fentanyl in those states Methadone 0 Sanger-Katz, NY Times, 2015 2016 2017 Aug 15, 2018 RECOMMENDATIONS FOR ADDRESSING THE CRISIS OF OPIATE OVERDOSE AND ADDICTION IN THE UNITED STATES prepared by Miriam Adelson, MD and Mary Jeanne Kreek, MD (November 2017; Updated April 2019) PROBLEM AND PREVENTION • Doctors, nurse practitioners, and dentists should not prescribe opiates for acute pain (short-term use) for longer than 7 days. • Further, they should encourage the patient to return any unused opiates to the physician, dentist, or pharmacy immediately. HISTORY OF PROBLEMS OF OPIOID OVERPRESCRIPTION AND MISUSE • Guidelines surrounding treatment of pain need to be revised to include a clear definition of acute pain versus chronic pain, with additional clarification of what kinds of chronic pain may respond to treatment with opiates (e.g., cancer-related pain and some types of neuropathic pain). • Types of pain which do not respond to chronic opiate treatment include pain related to essentially all types of arthritis, lower back pain, and many types of neurodegenerative diseases). • There is urgent need for development of new pain medications with novel neurobiological targets to treat the disorders in which pain is not relieved by opiate medications. Kreek, Adelson, 2017, 2019 2 Update on Laws Governing Prescribing of Opioids In Various States “In 2016, Massachusetts became the first state in the nation to pass a law limiting first time opioid prescriptions to 7 days.” (Of interest, at this meeting in June 2015, MJK, an early-morning speaker, had an invited public dialogue on this topic with newly elected governor, Charlie Baker, after his talk.) “Since then, over half of all states have enacted laws that restrict the prescribing or dispensing of opioids for acute pain. To date, there is no data on whether and to what extent these laws mediate opioid-related morbidity and mortality.” Subsequently, “fifteen states have passed laws limiting opioid prescribing for acute pain in an opioid naive patient to a 7-day supply. These states include Alaska, Hawaii, Colorado, Utah, Oklahoma, Louisiana, Missouri, Indiana, West Virginia, South Carolina, Pennsylvania, New York, Maine, Connecticut, Massachusetts. In addition, Arizona, North Carolina, and New Jersey limit initial prescribing to 5 days.” Pharmacy Times, February 5, 2019 RECOMMENDATIONS FOR ADDRESSING THE CRISIS OF OPIATE OVERDOSE AND ADDICTION IN THE UNITED STATES prepared by Miriam Adelson, MD and Mary Jeanne Kreek, MD (November 2017; Updated April 2019) ACUTE INTERVENTION FOR OVERDOSE.* • Naloxone (Narcan) is the only available effective treatment for narcotic overdose. It should be widely communicated that naloxone is effective for only 60-90 minutes; repeated doses of naloxone must be given when a long-acting opiate (or large dose of short-acting opiate) has caused the overdose. • For public health reasons, the cost of naloxone formulations should be kept appropriately low. *NB – According to SysGalaxy Market Research report Global Naloxone Market 2013-2018 and Forecast 2019-2024 ($2500 to purchase report), parenteral or nasal naloxone in different ampules or total doeses available from ADAPT Pharma, Amphastar Pharmaceuticals, Pfizer, kaleo, Sandoz, Amneal Pharmaceuticals, West Ward Pharmaceuticals, and Mylan. Kreek, Adelson, 2017, 2019 RECOMMENDATIONS FOR ADDRESSING THE CRISIS OF OPIATE OVERDOSE AND ADDICTION IN THE UNITED STATES prepared by Miriam Adelson, MD and Mary Jeanne Kreek, MD (November 2017; Updated April 2019) CHRONIC EFFECTIVE TREATMENT FOR OPIATE ADDICTION: MAINTENANCE TREATMENT WITH METHADONE OR BUPRENORPHINE-NALOXONE • Access to methadone maintenance treatment and buprenorphine-naloxone maintenance treatment should be expanded throughout the nation. Also, more long-term medical maintenance clinics are needed in all States. • The Federal Regulations surrounding criteria for entry into methadone maintenance treatment, which currently require one year of daily self- administration of a short accent opiate, should be appropriately reduced to match the criteria for entry into buprenorphine-naloxone treatment (i.e., when a physician identifies that opiate addiction exists, usually after three months of daily self-administration of any short-acting opiate). • Appropriate counseling, or other psychiatric or psychological care, should be strongly encouraged to augment buprenorphine-naloxone treatment (as is already required for methadone maintenance treatment). • Major medical centers should be encouraged to house onsite treatment programs so that patients may have access to top-level medical, psychiatric, and psychological health care. Kreek, Adelson, 2017, 2019 3 RECOMMENDATIONS FOR ADDRESSING THE CRISIS OF OPIATE OVERDOSE AND ADDICTION IN THE UNITED STATES prepared by Miriam Adelson, MD and Mary Jeanne Kreek, MD (November 2017; Updated April 2019) ELIMINATION OF STIGMA • Efforts should be made to educate the public that addictions are diseases of the brain, and not simply anti-social or criminal behaviors (as has been well- established by the scientific and medical community for over 50 years). • Further, efforts should be made to educate the public that excellent treatments are available, and that opiate addiction usually requires long- term, chronic treatment with medications like methadone or buprenorphine- naloxone, in the same way that diseases like hypertension and diabetes require long-term treatment with appropriate medications. Kreek, Adelson, 2017, 2019 Initial Development of Methadone Maintenance Treatment and Current Use of Maintenance Treatment with Methadone or Buprenorpine-Naloxone for Opiate Addiction The Beginning: 1963-1964 Treatment of Heroin Addiction: Identification of Need, Formulation of Hypothesis, Basic Clinical and Related Laboratory Research, Translational Research, and Evaluations Autumn Vincent P. Dole, Jr., MD recruitment of two new staff 1963 members to his Laboratory of Physiology and Metabolism at The Rockefeller Institute for Medical Research: 1) Marie Nyswander, MD – psychiatrist, years of work with heroin addicts in New York City and Lexington, KY. Author of book The Addict as a Patient. 2) Mary Jeanne Kreek, MD – second year Resident in (Internal) Medicine (“PGY-2”) at Cornell-New York Hospital with experience in clinical and laboratory based research at NIH and Columbia P&S. January – New team formed and first patients admitted to the July 1964 Rockefeller Hospital; initial research accomplished by July. AATOD 2013; EUROPAD 2014; 2019 4 55th Anniversary of Development of Methadone Maintenance Treatment Vincent P. Dole, Jr., MD;
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