The ATTC Network Ten Regional Centers northwest@attcnetwork.org www.attcnetwork.org/northwest phone. 206-685-4419 1107 NE 45 th St, Ste 120, Seattle, WA 98105 http://attcnetwork.org/northwest U.S. Opioid Epidemic U.S. Opioid Epidemic Distribution of Rx Opioids in Idaho 2016 ARCOS data, U.S. Drug Enforcement Administration, 2016
U.S. Drug Overdose Death Rates 1999-2016 U.S. Drug Overdose Death Rates by Age Group 1999-2016 Source: NCHS, National Vital Statistics System, Mortality Source: NCHS, National Vital Statistics System, Mortality U.S. Drug Overdose Death Rates 2016 Source: NCHS, National Vital Statistics System, Mortality Rate per 100,000 15 10 5 0 Opioid-Related Drug Deaths 1999-2016 1 9 9 9 2 0 0 1 2 0 0 3 2 0 0 5 2 0 0 7 2 0 0 9 2 0 1 1 2 0 1 3 2 0 1 5 Washington Oregon Alaska Idaho Centers for Disease Control and Prevention, National Center for Health Statistics; 1999-2016 on CDC WONDER Online Database Heroin-Related Drug Deaths in Idaho 2001-2016 2016 Prescription Drug Overdose Program Data, Idaho Dept. of Health and Welfare.
Drug-Drug Interactions CNS DEPRESSANTS SEDATIVE-HYPNOTICS ETHANOL, BARBITURATES, BENZODIAZEPINES OPIOID ANALGESICS MORPHINE, HEROIN, METHADONE, CODEINE, OXYCODONE, DEMEROL, FENTANYL HEROIN & OTHER OPIOIDS ACUTE USE SYMPTOMS DECREASED HEART RATE, BLOOD PRESSURE AND RESPIRATION RATE CONSTRICTED PUPILS DROOPING EYELIDS AND SLURRED SPEECH SLEEPINESS / SEDATION NAUSEA RELIEF OF PHYSICAL / EMOTIONAL PAIN (ANALGESIA) HEROIN & OTHER OPIOIDS CHRONIC USE SYMPTOMS Constipation Decreased Sexual Interest Tolerance Hyperalgesia Heroin & Illicit Prescription Opioids: Criminal lifestyle to support habit Lifestyle changes Hepatitis and HIV infection through needle sharing and other high risk acts Opioid Withdrawal Syndrome Acute Symptoms FLU-LIKE SYMPTOMS RUNNY NOSE WATERY EYES DILATED PUPILS GOOSE FLESH STOMACH CRAMPS & DIARRHEA INCREASED HEART RATE & BLOOD PRESSURE INTENSE DISCOMFORT 4-7 days (short-acting opioids) 10-21 days (methadone, if on long term) Opioid Withdrawal Syndrome Protracted Symptoms Deep muscle aches and pains Insomnia, disturbed sleep Poor appetite Reduced libido, impotence, anorgasmia Depressed mood, anhedonia Drug craving and obsession ADDICTION INVOLVES MULTIPLE FACTORS Biology/Genes Environment DRUG Brain Mechanisms Addiction
Drug Dependence: A Chronic Medical Illness Genetic Heritability twin studies Hypertension 25-50% Diabetes Type 1: 30-55%; Type 2: 80% Asthma 36-70% Nicotine 61% (both sexes) Alcohol 55% (males) Marijuana 52% (females) Heroin 34% (males) Voluntary Choice shaped by personality and environment Pathophysiology neurochemical adaptations Treatment Response Medications effectiveness and compliance Behavioral interventions McLellan, A.T., et.al., Drug Dependence, a Chronic Medical Illness Journal of the American Medical Association 284:1689-1695, 2000. If addiction is a chronic disease: Addiction treatment doesn t cure the disease. The goal of treatment is to: Provide patients the tools to help them manage their addiction and medications are among those tools Teach them how to use those tools to achieve and maintain recovery Psychological and Social Problems Opioid addiction treatment medicines X Addiction X Counseling & social supports Brain changes and Dependence Medications for the Treatment of Opioid Use Disorders Research clearly and consistently shows that medication assisted treatment for opioid use disorder saves lives and money. mortality rates were 75 percent higher among those receiving drug-free treatment compared to those receiving buprenorphine (or methadone) Health Affairs, August 2011 vol. 30 no. 8 1425-1433 How do Medications for Opioid Addiction Work? How do Medications for Opioid Addiction Work? There are three types of medications that can block the high : Agonists produce opioid effects Partial Agonists produce moderate opioid effects Antagonists block opioid effects Opioid Effect Full Agonist (e.g., methadone) Dose of Opioid Partial Agonist (e.g. buprenorphine) Antagonist (e.g. Naloxone)
How does methadone work? Treatment Outcome Data: Methadone Methadone binds to the same receptor sites as other opioids. Orally effective Slow onset of action Long duration of action Slow offset of action 8-10 fold reduction in death rate Reduction of drug use Reduction of criminal activity Engagement in socially productive roles; improved family and social function Improved physical and mental health Reduced spread of HIV Excellent retention Methadone Treatment Opioid Treatment Programs (OTPs) are regulated by CSAT, DEA, state laws and rules and accreditation bodies. Patients must come daily for the first 90 days in treatment; can qualify for takehome privileges with progress in recovery. Urine drug testing, treatment planning and counseling required. 4 OTPs in Idaho; all in or near Boise. Methadone & Pregnancy Fetal outcomes better on MMT than heroin; MOTHER study demonstrates less NAS with buprenorphine. Detoxification from opioids risky for fetus; put mother at risk for relapse to opioid use Hidden withdrawal (in utero) vs. Neonatal Abstinence Syndrome (NAS) Methadone dose needs to be monitored by a physician or ARNP/PA-C during pregnancy May need split dosing to improve serum stability Formulations of Buprenorphine Buprenorphine is currently marketed for opioid treatment under the trade names: Buprenorphine Buprenorphine/ Naloxone Subutex (buprenorphine) Suboxone Suboxone Sublingual Film (buprenorphine/naloxone) (buprenorphine/naloxone) Zubsolv (buprenorphine/naloxone) (1 Mo. Inj.) Sublocade 5.7 mg. bup./1.4 mg. nalox. 1.4 mg. bup./0.36 mg. nalox. Probuphine - 6 months implant requires surgical procedure 33
Drug Addiction Treatment Act of 2000 (DATA 2000) Expanded treatment options to include both the general health care system and opioid treatment programs. Expanded the number of available treatment slots Allows opioid treatment in office settings Sets physician qualifications for prescribing the medication Comprehensive Addiction and Recovery Act (2016) Gives nurse practitioners and physician assistants the ability to prescribe buprenorphine in states where those medical professionals have full practice authority. Physicians must: DATA 2000: Prescriber Qualifications Be licensed to practice by his/her state Have the capacity to refer patients for psychosocial treatment Originally limited to 30 patients later expanded to allow for 100 patients after the first year of experience; after two years can increase to 275 patients with some additional reporting requirements. Be qualified to provide buprenorphine (complete an 8 hour training) and receive a license waiver ARNPs and PA-Cs must: complete 24 hours of training. HHS has started issuing waivers to these professionals. DATA 2000: Waivered Prescribers in Idaho Physicians 78 ARNPs/PAs 37 SAMHSA Provider Locator: https://www.samhsa.gov/medicationassisted-treatment/physicianprogram-data/treatment-physicianlocator Why not more waivered prescribers in Idaho? What we know from studies in other states that impacts prescribers willingness to do this work: OUD patients are often present with complicated problems and prescribers may not feel they have enough resources/support to take them on. Afraid that their practice may be overwhelmed by new patients seeking MAT Reimbursement for services viewed as inadequate for the complexity of patient problems. Lack of viable counseling/support resources in the community to which to refer. Idaho Medicaid Buprenorphine and Buprenorphine/Naloxone Utilization (2011-2017) 2017) Idaho Division of Medicaid (September 2017) Physician-Based vs. Clinic-Based Treatment In clinic-based treatment there are many rules (observed dosing, counseling, urinalysis), imposed by regulatory authorities (federal & state); physicianbased treatment has no such rules, only guidelines. Physician-based perhaps more geographically available and certainly more private.
Specific Research on Buprenorphine and Pregnancy MOTHER Study, Jones, et.al., 2010. Randomized double blind, double dummy comparison between methadone and buprenorphine (Subutex ) in pregnant women in a large multi-site trial. Women dosed daily under observation 7 days per week. No difference in NAS frequency in babies born to mothers on either medication. Two statistically significant findings: shorter hospital stay for buprenorphine, less NAS medication used. No data available to inform determination of patients who should be maintained on methadone rather than buprenorphine Comprehensive integrated services and daily observation (methadone clinic) vs. office based medication. Clinical Guidance for Treating Pregnant and Parenting Women with OUD: https://store.samhsa.gov/shin/conte nt//sma18-5054/sma18-5054.pdf The Prescription Opioid Addiction Treatment Study (POATS) Largest study ever conducted for prescription opioid dependence 653 participants enrolled Compared treatments for prescription opioid dependence, using buprenorphine-naloxone and counseling Conducted as part of NIDA Clinical Trials Network (CTN) at 10 participating sites across U.S. Examined detoxification as initial treatment strategy, and for those who were unsuccessful, how well buprenorphine stabilization worked 42 Take Home Message: News from the 42 month Follow-up Results revealed significant improvements at 42 months: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; 31.4% were using opioids without agonist therapy Weiss RD, et al. Long-Term Outcomes from the National Drug Abuse Treatment Clinical Trial Network Prescription Opioid Study. Drug and Alcohol Dependence 2015 (in press) 43 Opioid Antagonists How Does Naltrexone Work? Naltrexone Naltrexone for Extended- Release Injectable Suspension Naltrexone is an opioid receptor antagonist and blocks opioid receptors. Revia or Depade Vivitrol This prevents the effects of selfadministered opioids. Naltrexone
Naltrexone Hydrocholoride What Does the Research Say? Marketed As: ReVia and Depade Indication Used in the treatment of alcohol or opioid dependence and for the blockade of the effects of exogenous administered opioids and/or decreasing the pleasurable effects experienced by consuming alcohol. Has not been found to be addictive or produce withdrawal symptoms when the medication is ceased. Administering naltrexone will invoke opioid withdrawal symptoms in patients who are physically dependent on opioids. Naltrexone is effective for opioid and alcohol addiction: Reduces risk of re-imprisonment Lowers risk of opioid use, with or without psychological support Extended-release naltrexone addresses the issue of patient compliance Extended-Release Naltrexone Dosing: Induction Burden One 380mg injection deep muscle in the buttock, : every 4 weeks Must be administered by a healthcare professional and should alternate buttocks each month. Blocks opioid receptors for one entire month compared to approximately 28 doses of oral naltrexone. It is not possible to remove it from the body once extended-release naltrexone has been injected. Pricing: $800 1200 per month (one injection) Abstinence requirements: must be taken at least 7-10 days after last consumption of opioids What do we know about MAT? The medications can be highly effective in reducing the morbidity and mortality associated with OUD. Detoxification from opioids alone increases the risk of overdose. Drug-free counseling alone is much less effective in reducing harms and leading to recovery. Volkow ND, McLellan AT. N Engl J Med 2016;374:1253-1263
Methadone Maintenance vs. 180 Day Detoxification What do we know about MAT? 12 month study of 179 opioid dependent patients randomly assigned to: Methadone Maintenance mean dose=85.3mg for 14 months 180 Day Methadone Detoxification mean dose=86.3 mg prior to taper at 120 days followed by psychosocial Tx for 8 months Methadone maintenance therapy resulted in greater treatment retention and lower heroin use rates than did detoxification. K.L. Sees et al., JAMA 2000 The medications provide a platform of neurochemical support so that the person on MAT can start making the changes toward recovery from OUD. William White on MAT & Recovery What don t we know about MAT? Recovery Support for People in Medication Assisted Recovery: The Context April 27, 2018 http://www.williamwhitepapers.com/blog/2018/04/recove ry-support-for-people-in-medication-assisted-recoverythe-context.html Recovery-oriented Methadone Maintenance http://www.williamwhitepapers.com/books_monographs/ Which medication is the best fit for a person with OUD. How long a person needs to remain on MAT. Whether or not and for how long counseling should be required for a person on MAT. Fig. 1 Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population Morgan JR, et.al., Journal of Substance Abuse Treatment Volume 85, Pages 90-96 (February 2018) National Resources 5/11/2018 Drug information and research findings National Institute on Drug Abuse (NIDA) https://www.drugabuse.gov/ Medication-Assisted Treatment Substance Abuse & Mental Health Services Administration https://www.samhsa.gov/medication-assistedtreatment Evidence-Based Practices - SAMHSA https://www.samhsa.gov/ebp-resource-center
National Resources Medications for the Treatment of Opioid Use Disorder TIP 63 https://store.samhsa.gov/product/sma18-5063fulldoc Opioid Addiction: A Chronic Disease: Brochure for AI/AN Communities: http://ctndisseminationlibrary.org/pdf/aianopioidaddiction.pdf