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What Pediatric Primary Care Providers Need to Know About Medication Assisted Therapy for Adolescent Opioid Addiction Diana Deister, MS, MD Child and Adolescent Psychiatrist Adolescent Substance Use and Addictions Program Division of Developmental Medicine Boston Children’s Hospital October 24th, 2017
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Disclosure Diana Deister, MS, MD has no relationships with commercial companies to disclose.
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Learning outcomes Review the neurobiology of opioids
Review the epidemiology of opioid use in adolescents and opioid related deaths in MA Review the evidence for appropriate use of medication-assisted therapy (MAT) for opioid use disorders in adolescents Understand how to monitor patients on MAT even if they are receiving MAT elsewhere
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Opiates Opioids 20 mg Oxycodone
Adolescent Substance Abuse: New Strategies for Primary Care 5
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Opioid Pharmacology The human body produces molecules called “endorphins” that bind to mu-opioid receptors. Binding in the CNS results in a sense of well-being, satisfaction and pleasure, all of which are important for homeostasis. Opioids mimic endorphins and bind to the same receptor. Opioid µ-receptor and agonist The human body also has kappa and delta opioid receptors, though their role in addiction is not well defined.
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CNS Areas with High Mu-Opioid Receptor Density
Brain Region Function Prefrontal Cortex “Executive Functions” Limbic System** Pleasure and Reward Brain Stem Respiration, Cough Spinal Cord Pain ** The limbic system is one of the “oldest” portions of the brain, is critical for adaptive memory and plays an important role in addiction.
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A Dynamic System Immediately after tissue injury, spinal cord receptors become available, allowing injured patients to tolerate large opioid doses without euphoria or overdose. The same large dose could result in overdose in the same individual, once the pain has subsided and receptors are downregulated. Pain patients on appropriate treatment should not experience a euphoric “high,” which reduces the risk of developing an addiction.
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Physiologic Adaptations: Tolerance and Withdrawal
Tolerance is the need for increasing amounts of the substance to achieve the desired effect. Withdrawal is a physiological response to a rapid decline in receptor binding, due to either rapidly decreasing concentrations of the opioid, or presence of a blocking agent. Symptoms are listed on the next slide. Note that tolerance and withdrawal occur whenever there has been chronic exposure to opioids – whether for long term pain management or in addiction. Tolerance and withdrawal alone are not sufficient to make a diagnosis of addiction. . American Psychiatric Association. DSM IV-TR. Diagnostic and Statistical Manual of Mental Disorders Text Revision Fourth Edition ed. Washington DC; 2000. 18
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Opioid Withdrawal Dysphoric Mood Insomnia Nausea/Vomiting Diarrhea
Muscle aches/cramps Sweating Lacrimation Rhinorrhea Hypertension Tachycardia The signs listed above are all consistent with opioid withdrawal. These can be quantified using the “Clinical Opioid Withdrawal Scale,” or COWS. A COWS is used to follow patients who are detoxing.
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Length and Timing of Withdrawal Period
Short-acting opioids (e.g., heroin, hydrocodone, oxycodone): withdrawal usually begins 6-12 hours after last dose, peaks at hours, and lasts about 5 days Long-acting opioids (e.g., methadone, buprenorphine): withdrawal begins hours after last dose, peaks at 4-5 days, and can last up to 2 weeks.
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VIETNAM WAR Civil War METHADONE HARRISON DRUG ACT
“PAIN” AS THE 5th VITAL SIGN Civil War 1914 1974 1860’s 1970’s 1999 METHADONE HARRISON DRUG ACT
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Increase in Opioid Rx, 1991-2013 No. of Rx’s (millions)
Nearly threefold increase in 22 years from 76 million to 207 million prescriptions. Volkow ND. America’s Addiction to Opioids: Heroin and Prescription Drug Abuse. Natl. Inst. Drug Abus Available at:
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Monitoring the Future 2015 survey
Monitoring the Future is an annual survey of 8th, 10th, and 12th graders conducted by researchers at the University of Michigan, Ann Arbor, under a grant from the National Institute on Drug Abuse, part of the National Institutes of Health. Since 1975, the survey has measured drug, alcohol, and cigarette use and related attitudes in 12th graders nationwide. Eighth and 10th graders were added to the survey in 1991. Overall, 44,892 students from 382 public and private schools participated in the 2015 survey.
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Monitoring the Future 2015 – 8/10/12th graders, Past Month Use
Courtesy of NIDA:
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Monitoring the Future 2015 survey – 12th graders, Past Year Use
Courtesy of NIDA:
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Rates of opioid misuse by 12th graders
Source: Johnston LD, et al., Monitoring the Future – National Results on Adolescent Drug Use: Overview of Key Findings, 2016
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Mass Opioid Death Rate
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Confirmed Unintentional/Undetermined1 Opioid-related Deaths Compared to All Deaths by Age: January 2016-December 2016 1 Unintentional poisoning/overdose deaths combine unintentional and undetermined intents to account for a change in death coding that occurred in Suicides are excluded from this analysis. Note: Due to rounding, percentages under “All Deaths” do not add up to 100%.
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Reason for Opioid Misuse
Easy to get from medicine cabinet 62% Available everywhere 52% Not illegal 51% Easy to get through other people’s prescription 50% Can claim you have a prescription if caught 49% Cheap 43% Safer to use than illegal drug 35% Less shame attached to using 33% Easy to purchase over the Internet 32% Fewer side effects than street drugs Parents don’t care as much if you get caught 21% Lifetime opioid misuse rates rose dramatically between 1993 and 2003, and has subsequently leveled off near 13%. Nearly half of all new recreational users of prescription pain medications are under 18. Partnership for a Drug-Free America. The Partnership Attitude Tracking Study (PATS): Teens in grades 7 through ; May 16, 2006
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Heroin Heroin (di-acetyl morphine) rapidly crosses the blood brain barrier, where it is metabolized to morphine, resulting in very rapid delivery of morphine to the central nervous system. Because it is potent and relatively inexpensive, individuals who have become addicted to opioids may switch to heroin to combat tolerance Increased purity of heroin since the 1990s has made snorting or smoking practical alternatives to injecting, thus lowering the barrier to initiate use.
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Age of onset of non-medical use of prescription drugs
Source: McCabe SE et al. Does early onset of non-medical use of prescription drugs predict subsequent prescription drug abuse and dependence? Results from a national study. Addiction (12):
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Prescribed opioid use Opioid misuse
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Association between prescribed opioids and opioid misuse
Prescribed pain relief AOR: 1.33 (95% CI ) McCabe (2017): Of those adolescents who reported both medical and nonmedical use of opioids, most reported medical use prior to NUPO. (Can’t find AOR) Source: Miech, et al. Pediatrics. (2015). 136(5):e
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Prescribed opioid use Opioid misuse Alc/MJ/tobacco use
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Gateway to Opioid Misuse
Lifetime Marijuana use AOR: 2.44 (95% CI ) Lifetime Cigarette use AOR: 1.25 (95% CI ) What does exposure mean here? What type of opioid use – misuse, opioid use disorder, pills, heroin, any opioid *summarize study here Lifetime Alcohol use AOR: 1.23 (95% CI ) Source: Fiellin et al. (2013) Prior use of alcohol, cigarettes, and marijuana and subsequent abuse of prescription opioids in young adults.
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Opioid addiction Opioid misuse Prescribed opioid use Younger age
Genetic vulnerability Mental health disorders Motivation Opioid misuse Opioid addiction Alc/MJ/tobacco use
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Younger age* AOR = adjusted odds ratio *AOR decreases by 5% each year that non-medical use is delayed (after one year, AOR: 0.95 with 95% CI ) Sources: McCabe et al. Addiction. (2007). 102(12):
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Mental health and opioid use
Familial alcohol problem/drug use Drug abuse/Dependence OR: Major depression, anxiety disorder, or panic disorder Opioid use OR: 4.43 (95% CI ) PTSD Drug abuse/Dependence OR: 8.68 Sources: 1) Kilpatrick DG, Acierno R, Saunders B, Resnick HS, Best CL, Schnurr PP (2000). 2) Risk Factors for Adolescent Substance Abuse and Dependence: Data From a National Sample. J Consult and Clin Psych 63(1): ) Sullivan MD, Edlund MJ, Zhang L, Unützer J, Wells KB (2006). Association Between Mental Health Disorders, Problem Drug Use, and Regular Prescription Opioid Use. Arch Intern Med 166(19):
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Motivations for opioid misuse
11.1% of 12th graders have misused prescription opioids in their lifetime Source: McCabe et al. Add Behav (5):651-6.
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Association between motivation for use and Opioid Use Disorder
Unprescribed pain relief AOR: 1.8 (95% CI ) Boyd et al., 2009: Refers to the increased odds of “general substance or opioid abuse/dependence disorder.” (abstract) but later only refers to substance use disorder. “For every additional motive endorsed, the odds of a positive score on the DAST-10 (positive score meaning moderate level of risk for substance abuse/self-treatment with opioids) increased by a factor of 1.8.” (Boyd et al., 2006) Recreational use AOR: 3.42 (95% CI ) Sources : 1) Boyd et al. J. Addict Dis (3): ) Boyd et al. Pediatrics. (2006). 118(6):
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DSM-5 Criteria for Substance Use Disorder
Use in larger amounts or for longer periods of time than intended Unsuccessful efforts to cut down or quit. Excessive time spent taking the drug Failure to fulfill major obligations Continued use despite knowledge of problems Important activities given up Recurrent use in physically hazardous situations Continued use despite social or interpersonal problems Tolerance Withdrawal Craving Severity is designated according to the number of symptoms endorsed: 0 - 1: No diagnosis 2 - 3: mild SUD 4 - 5 : moderate SUD 6 or more: Severe SUD
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Overview of Treatment for Opioid Addiction
Non-pharmacologic Pharmacologic Residential Treatment Detox methadone, buprenorphine, clonidine, “comfort meds” Intensive Outpatient/Partial 12-Step Fellowships and other Peer support groups Antagonist Therapy naltrexone PO or IM Individual, Group, or Family Therapy Agonist Therapy methadone, buprenorphine Therapeutic School/Community Opioid dependence is a chronic, relapsing neurological condition; patients who remain in long-term treatment generally do best. Supportive therapy combined with pharmacologic treatment seems to produce the best outcomes. Most efficacy studies have been done with adults, and little is known about the effects of treating developing adolescents with opioid agonists.
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Pharmacologic Treatment Options
Detoxification: eases discomfort associated with withdrawal. Can be achieved with opioids or non-opioid “comfort meds” such as ibuprofen, trazodone and clonidine for symptomatic relief. Opioid Antagonist Therapy: “blocks” opioid receptor so patients cannot get high. Naltrexone used for long-term treatment can be given PO or IM. Opioid Agonist Therapy: long-term treatment aimed at quelling cravings, improving functioning and reducing relapse rates. Options include methadone (full agonist) and buprenorphine (partial agonist).
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Detoxification Adult studies have recurrently found high relapse rates after detoxification without subsequent treatment. An NIH consensus statement regarding treatment of opioid dependent adults indicated detoxification alone is insufficient treatment. National Institute of Health Consensus Development Conference Statement, 1997. Kosten TR, Schottenfeld R, Ziedonis D, Falcioni J. Buprenorphine versus methadone maintenance for opioid dependence. Journal of Nervous and Mental Disease 1993;181(6): ; Mattick et al., Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients., Addiction, 2003 Apr;98(4): ; Gowing, L., Buprenorphine for the management of opioid withdrawal., Cochrane Database Syst Rev. 2000;(3):CD Woody, GE., et al. Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth. JAMA 300(17) : , 2008.
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Medication Assisted Treatment
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Opioid Function at Receptors
Different exogenous molecules have varying levels of “fit” at the opioid receptor, resulting in different levels of receptor activity with binding Substances are divided into three groups: full agonists, partial agonists and antagonists. In general, antagonists have the highest receptor affinity and full agonists the lowest.
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Methadone Methadone – very limited options for patients under age 18
Schedule II Highly regulated Can only be prescribed through “methadone clinics”; very few can take patients under 18 years old. Methadone programs are highly structured, which offers an advantage for patients, especially with limited social support Some patients who are not successful with the partial agonist buprenorphine can be successful with methadone. Studies in adults comparing methadone to buprenorphine have found nearly identical treatment retention and outcomes
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Partial Agonist Therapy: Buprenorphine
Partial agonists occupy the receptor and blocks binding of full strength opioids. Receptors are only partially activated even with full occupancy Less reinforcing and less commonly abused than full agonists. The potential for misuse is not zero
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Buprenorphine Buprenorphine – FDA indication for treating patients > 16 years Schedule III Can be prescribed from physician offices Combination product (with naloxone) limits misuse potential Antagonist properties may be therapeutically useful Safer than methadone in overdose Mildly reinforcing which may support medication adherence Studies in adults comparing methadone to buprenorphine have found nearly identical treatment retention and outcomes
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Buprenorphine Preparations
Buprenorphine/naloxone combination product is the recommended formulation for treatment of opioid dependence Naloxone is present only to reduce diversion to injected abuse When taken sublingually, naloxone is poorly absorbed and has no physiologic effect Patients who use the combination product IV or IN get primarily blocking from naloxone (and can precipitate withdrawal) rather than euphoria from a large dose of buprenorphine Buprenorphine Naloxone
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Research Trials with Adolescents
Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth: A Randomized Trial Study design Participants years old with opioid dependence via DSM-IV, N=152 Randomly assigned to 1 of 2 groups: 2-week detox w/ max dose of 14 mg/day buprenorphine (n=78) 12-week treatment buprenorphine-naloxone w/ max dose of 24 mg/day for 5-7 days/ week for 12 weeks (n=74) All participants received group and individual counseling each week for 12 weeks Methods Randomized-controlled trial Participants years old, N=156 2-week detox vs 12-week treatment All patients also received 2 counseling sessions (1 individual and 1 group) for 12 weeks Results Compared to patients who received 2 week detox, those who received 12 weeks of medication assisted treatment Had better treatment retention Had fewer positive opioid drug tests at 4 and 8 weeks and fewer positive opioid tests overall : No differences by 12 weeks The authors concluded that based on their study, longer-term opioid replacement is superior to short term. Department of Pschiatry UPENN: JAMA.†2008;300(17): Woody, GE., et al. JAMA 300(17) : , 2008
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Research Trials with Adolescents
Extended vs. Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth: A Randomized Trial Summary of Findings Fewer Opioid positive urine screens in 12-week-treatment group Higher retention rates in 12-week-treatment group Methods Randomized-controlled trial Participants years old, N=156 2-week detox vs 12-week treatment All patients also received 2 counseling sessions (1 individual and 1 group) for 12 weeks Results Compared to patients who received 2 week detox, those who received 12 weeks of medication assisted treatment Had better treatment retention Had fewer positive opioid drug tests at 4 and 8 weeks and fewer positive opioid tests overall : No differences by 12 weeks The authors concluded that based on their study, longer-term opioid replacement is superior to short term. Department of Pschiatry UPENN: JAMA.†2008;300(17): Woody, GE., et al. JAMA 300(17) : , 2008
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Buprenorphine Waiver Training:
The Half and Half Course – specifically for Pediatricians and Family Physicians in addressing adolescent specific issues Prescriber’s Clinical Support System
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Treatment with Naltrexone: Overview
FDA indication for Naltrexone is a long-acting, high affinity, competitive opioid receptor antagonist with an active metabolite (6-β-naltrexol) Naltrexone blocks the euphoric effects of opioid use. A study with adults aged 18 and over found that compared to placebo, patients who received naltrexone had less opioid use, better treatment retention and fewer cravings. There are no data regarding the efficacy or adverse effects profile in children. Krupitsky et al., 201
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Naltrexone: Pharmacology
5-40% bioavailability when administered orally Metabolized in the liver, renal excretion Effective opioid blockade lasts from 1-3 days depending on dose Recommended adult dose is 50 mg daily or 380 mg IM monthly Naltrexone can precipitate opioid withdrawal; start after the withdrawal period is completed – generally 7 days, longer if patient had been using long acting opioid such as methadone
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Efficacy of Naltrexone: oral vs. XR injection
Retention in treatment is used as a primary outcome of treatment with NTX as a great majority of patients retained on NTX are abstinent from opioids Treatment retention rate in groups treated with XR preparations is twice that of the oral group, approximating 50-70% at 6 months
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How long will my patient be on MAT?
SUD’s are like any chronic illness requiring maintenance treatment. Early sobriety Longer sobriety Relapse Early Sobriety, etc Patient response to treatment is individual, but should be multi-modal Changes to lifestyle / diet / exercise help Psychosocial support should start with MAT and continue after its discontinuation Individual medication needs vary in short term and long term
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Monitor Directly observed induction All medication observed by parents
Pill counts at each visit Small prescriptions, no early refills Random drug testing to monitor for medication compliance and use of illicit drugs
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MAT with outside provider
Get a release to speak with the provider that specifically states substance abuse treatment is part of the information being communicated Notify external provider about critical medical updates Monitoring patients who get MAT somewhere else Drug tests – you can order them! Buprenorphine/norbuprenorphine should be in the sample if patient is taking this medication
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Conclusions Opioid use among adolescents and young adults is a serious problem with potentially life-threatening consequences Pediatric health care providers can have a significant impact on this problem by: Recognizing that adolescents can develop opioid use disorders Using caution in prescribing opioids Counseling patients and parents about prescription drug misuse Supporting medication-assisted treatment for patients with severe opioid use disorders
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Adolescent Substance Abuse Program (ASAP)
Acknowledgements Adolescent Substance Abuse Program (ASAP) Clinicians Diana Deister, MD, MS Leslie Green, MSW, LICSW Scott Hadland, MD, MPH Sharon Levy, MD, MPH Shannon Mountain-Ray, MSW, LICSW Patricia Schram, MD Jesse Schram, LICSW Nicholas Chadi, MD Research Assistants Dylan Kaye, BA Lily Rabinow, MS Parissa Salimian, BA Meghana Vijaysimha, MPH Rosemary Ziemnik, BS Teaching Collaborators Pamela Burke, PhD, RN, FNP, PNP, FSAHM, FAAN Linda Malone, DNP, RN, CPNP Sarah Pitts, MD Marianne Pugatch, MSW, LICSW Jennifer Putney, PhD, LICSW Research Collaborators Co-principal investigators: Elissa Weitzman, ScD, Msc & Sharon Levy, MD, MPH Elizabeth Harstad, MD, MPH Lauren Wisk, PhD Research Project Management Julie Lunstead, MPH, Program Manager Erin Huang, MPH, Data Manager PCSS MAT Training Providers' Clinical Support System for Medication Assisted Treatment
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