9/18/2013. Buprenorphine for Opioid Dependence: NIDA/SAMHSA Blending Initiative. According to the Webster Dictionary definition

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1 2013 Annual Conference for Behavioral Health Wichita, Kansas September 18, 2013 Alex Barajas-Muñoz, MS Buprenorphine for Opioid Dependence: A Training for Multidisciplinary Addiction Professionals NIDA/SAMHSA Blending Initiative According to the Webster Dictionary definition To Blend means: a. combine into an integrated whole; b. produce a harmonious effect webster.com/dictionary/blend 1

2 NIDA/SAMHSA Blending Initiative Developed in 2001 by NIDA and SAMHSA/CSAT, the initiative was designed to meld science and practice to improve addiction treatment. "Blending Teams," include staff from CSAT's ATTCs and NIDA researchers who develop methods for dissemination of research results for adoption and implementation into practice. Scientific findings are able to reach the frontline service providers treating people with substance use disorders. This is imperative to the success of drug abuse treatment programs throughout the country. Blending Team Members Leslie Amass, Ph.D. Friends Research Institute, Inc. Greg Brigham, Ph.D. CTN Ohio Valley Node Glenda Clare, M.A. Central East ATTC Gail Dixon, M.A. Southern Coast ATTC Beth Finnerty, M.P.H. Pacific Southwest ATTC Thomas Freese, Ph.D. Pacific Southwest ATTC Eric Strain, M.D. Johns Hopkins University ATTC representative NIDA researcher/community treatment provider Additional Contributors Judith Martin, M.D. 14th Street Clinic, Oakland, CA Michael McCann, M.A. Matrix Institute on Addictions Jeanne Obert, MFT, MSM Matrix Institute on Addictions Donald Wesson, M.D. Independent Consultant The ATTC National Office The O.A.S.I.S. Clinic developed and granted permission for inclusion of the video, Put Your Smack Down! A Video about Buprenorphine 2

3 Goals for the Training Understand the history of opioid treatment in the United States. Understand changes in the laws regarding treatment of opioid addiction and the implications for the treatment system. Identify groups of people who are using opioids. Understand how buprenorphine will benefit the delivery of opioid treatment. Introduction Please introduce yourself: Your name and the organization in which you work Experiencewith opioid treatment Your expectations for this training So who are the participants in this endeavor? 3

4 An Introduction to SAMHSA/CSAT SAMHSA/CSAT CSAT s Mission: To improve the lives of individuals and families affected by alcohol and drug abuse by ensuring access to clinically sound, costeffective addiction treatment that reduces the health and social costs to our communities and the nation. CSAT's initiatives and programs are based on research findings and the general consensus of experts in the addiction field that, for most individuals, treatment and recovery work best in a community based, coordinated system of comprehensive services. Because no single treatment approach is effective for all persons, CSAT supports the nation's effort to provide multiple treatment modalities, evaluate treatment effectiveness, and use evaluation results to enhance treatment and recovery approaches. The ATTC Network 4

5 ATTC Network Regional Centers An Introduction to NIDA The Mission of the National Institute on Drug Abuse To lead the Nation in bringing the power of science to bear on drug abuse and addiction This charge has two critical components. Strategic support and conduct of research across a broad range of disciplines Ensuring the rapid and effective dissemination and use of the result of that research to significantly improve prevention, treatment and policy as it relates to drug use and addiction 5

6 So what is this thing called the CTN? NIDA s Clinical Trials Network Established in 1999 NIDA s largest initiative to blend research and clinical practice by bringing promising therapies to community treatment providers Network of 16 University based Regional Research and Training Centers (RRTCs) involving 240 Community Treatment Programs (CTPs) in 23 states, Washington D.C., and Puerto Rico CTN Node Community Treatment Program Community Treatment Program Community Treatment Program Regional Research & Training Center Community Treatment Program Community Treatment Program Community Treatment Program Community Treatment Program Community Treatment Program 6

7 What do we know? What are your thoughts about buprenorphine? What hopes/concerns do you have about buprenorphine coming to your community? Buprenorphine Treatment: The Myths and The Facts MYTH #1: Patients are still addicted FACT: Addiction is pathologic use of a substance and may or may not include physical dependence. Physical dependence on a medication for treatment of a medical problem does not mean the person is engaging in pathologic use and other behaviors. 7

8 MYTH #2: Buprenorphine is simply a substitute for heroin or other opioids FACT: Buprenorphine is a replacement medication; it is not simply a substitute Buprenorphine is a legally prescribed medication, not illegally obtained. Buprenorphine is a medication taken sublingually, a very safe route of administration. Buprenorphine allows the person to function normally. MYTH #3: Providing medication alone is sufficient treatment for opioid addiction FACT: Buprenorphine is an important treatment option. However, the complete treatment package must include other elements, as well. Combining pharmacotherapy with counseling and other ancillary services increases the likelihood of success. MYTH #4: Patients are still getting high FACT: When taken sublingually, buprenorphine is slower acting, and does not provide the same rush as heroin. Buprenorphine has a ceiling effect resulting in lowered experience of the euphoria felt at higher doses. 8

9 A Brief History of Opioid Treatment A Brief History of Opioid Treatment 1964: Methadone is approved. 1974: Narcotic Treatment Act limits methadone treatment to specifically licensed Opioid Treatment Programs (OTPs). 1984: Naltrexone is approved, but has continued to be rarely used (approved in 1994 for alcohol addiction). 1993: LAAM is approved (for non pregnant patients only), but is underutilized. A Brief History of Opioid Treatment 2000: Drug Addiction Treatment Act of 2000 (DATA 2000) expands the clinical context of medicationassisted opioid treatment. 2002: Tablet formulations of buprenorphine (Subutex ) and buprenorphine/naloxone (Suboxone ) were approved by the Food and Drug Administration (FDA). 2004: Sale and distribution of ORLAAM is discontinued. 9

10 Understanding DATA 2000 Drug Addiction Treatment Act of 2000 (DATA 2000) Expands treatment options to include both the general health care system and opioid treatment programs. Expands number of available treatment slots Allows opioid treatment in office settings Sets physician qualifications for prescribing the medication DATA 2000: Physician Qualifications Physicians must: Be licensed to practice by his/her state Have the capacity to refer patients for psychosocial treatment Limit number of patients receiving buprenorphine to 30 patients for a least the first year File for a new waiver after first year to increase their limit to 100 patients. Be qualified to provide buprenorphine and receive a license waiver 10

11 DATA 2000: Physician Qualifications A physician must meet one or more of the following qualifications: Board certified in Addiction Psychiatry Certified in Addiction Medicine by ASAM or AOA Served as Investigator in buprenorphine clinical trials Completed 8 hours of training by ASAM, AAAP, AMA, AOA, APA (or other organizations that may be designated by Health and Human Services) Training or experience as determined by state medical licensing board Other criteria established through regulation by Health and Human Services Approval of Buprenorphine and Buprenorphine/Naloxone U.S. FDA approved buprenorphine (marketed as Subutex ) and buprenorphine/naloxone (marketed as Suboxone ) for opioid addiction treatment on October 8, Product launched in U.S. in March 2003 Interim rule changes to federal regulation (42 CFR Part 8) on May 22, 2003 enabled Opioid Treatment Programs (specialist clinics) to offer buprenorphine. Approval of Buprenorphine and Buprenorphine/Naloxone (SAMHSA, 2006) 11

12 Only physicians can prescribe the medication. However, the entire treatment system should be engaged. Effective treatment generally requires many facets. Treatment providers are important in helping the patients to: Manage physical withdrawal symptoms Understand the behavioral and cognitive changes resulting from drug use Achieve long term changes and prevent relapse Establish ongoing communication between physician and community provider to ensure coordinated care Engage in a flexible treatment plan to help them achieve recovery Prevalence of Opioid Use and Abuse in the United States 12

13 Rates of Current Heroin Use Drug demand data show that, nationally, current heroin use is stable or decreasing. Rates of Past Year Heroin Use NSDUH, 2009 % of US population Individuals (12 & older) Adolescents (12 17) Adults (18 25) Adults (26 & older) (SAMHSA, NSDUH, 2009) Who Uses Heroin? Individuals of all ages use heroin: More than 3.8 million US residents aged 12 and older have used heroin at least once in their lifetime. Heroin use among high school students is a particular problem. Slightly more than 2% percent of US high school seniors used heroin at least once during their lifetime. Approximately 1.6% of young adults (ages 19 28) reported lifetime use (CDC, 2009; SAMHSA, NSDUH, 2007) Prevalence of Use Rates of heroin use are declining among youth 8 th grade use peaked in th grade use peaked in th grade use peaked in 2000 Rates of non medical use of opioids are increasing Rates in all ages peaked in 2007 Rates highest in year olds (Johnston et al., 2009; SAMHSA, OAS, NSDUH, 2009) 13

14 Initiation of Heroin Use During the latter half of the 1990s, the annual number of heroin initiates rose to a level not reached since the late 1970s. In 1974, there were an estimated 246,000 heroin initiates. Between 1988 and 1994, the annual number of new users ranged from 28,000 to 80,000. Between 1995 and 2001, the number of new heroin users was consistently greater than 100,000. Between 2002 and 2008, the number of new heroin users ranged from 91,000 to 114,000. (SAMHSA, OAS, 2008; SAMHSA, NSDUH, 2009) Other Opioid Use in a National Survey Population According to the 2007 National Survey on Drug Use and Health: An estimated 6.9 million persons (2.8% of the U.S. population aged 12 or older) were currently using certain prescription drugs nonmedically. An estimated 5.2 million were current users of pain relievers for nonmedical purposes. Approximately 4.4 million persons had used OxyContin nonmedically at least once in their lifetime. Non medical pain reliever incidence increased from 1990 (628,000 initiates) to 2007, when there were 2.1 million new users. (SAMHSA, OAS, 2008; SAMHSA, NSDUH, 2009) The Prescription Drug Epidemic is Unique in Some Ways Prescription drugs are not inherently bad When used appropriately, they are safe and necessary Threat comes from abuse and diversion Just because prescription drugs are legal and are prescribed by an MD, they are not necessarily safer than illicit substances. SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse

15 Prescription Drugs are Easy to Obtain Easily obtainable from family, friends, and health care professionals (doctors, dentists, pharmacists) Medicine cabinets are likely source Pill mills and storefront pain clinics Internet online pharmacies Credit card number + access to computer No prescription necessary No/incomplete identity verification SOURCE: ATTC National Office, CONNECT to Fight Prescription Drug Abuse. 43 Sources Where Pain Relievers were Obtained: Past Year Non-Medical Users Aged 12 or Older: % Friend/Relative for Free Bought from Friend/Relative Took from Friend/Relative Prescription from One Doctor From Drug Dealer or Stranger From Internet Other/unknown 11.4% 17.3% 4.4% 6.7% 0.4% 55.0% SOURCE: SAMHSA, NSDUH, 2010 results. 44 Emergency Department Visits Related to Heroin/Other Opioids According to the Drug Abuse Warning Network : An estimated 200,666 drug misuse/abuse ED visits were related to heroin. One third (33%) of nonmedical use ED visits were related to Central Nervous System (CNS) agents. Among CNS agents, the most frequent drugs were opiates/opioid analgesics, specifically: Hydrocodone/combinations (22,912 visits) Oxycodone/combinations (44,489 visits) Methadone (23,498 ED visits) (SAMHSA, OAS, DAWN, 2009) 15

16 New Non-Medical Users of Pain Relievers In million new non medical users (a decline from 2.5 million in 2003, but still a lot!) 6,000 new users per day Among youth aged 12 17, females more likely to use non medically Among young adults aged 18 25, males more likely to use non medically (SAMHSA, OAS, 2009) New Non-Medical Users of Prescription Pain Relievers In million new non-medical users Approximately 5,500 new users per day Among persons aged 12 to 49, average age at first use was 21.0 years for pain relievers 17.6% of new illicit drug initiates reported pain relievers as first drug used SOURCE: SAMHSA, OAS, NSDUH, 2010 results. 47 Past Month Illicit Drug Use among Persons Aged 12 or Older: U.S., 2010 SOURCE: SAMHSA, OAS, NSDUH, 2010 results. Numbers in Millions 48 16

17 Percentage of U.S. Population with Past Month Non- Medical Use of Prescription Medications, by Type Percent Using in Past Month SOURCE: SAMHSA, OAS, NSDUH, 2010 results. 49 Lifetime Non-Medical Use of Prescription Pain Relievers among Individuals Aged 12 or Older Drug % Change Darvocet/Darvon 7.9% 7.0% 0.9% Percocet/Percodan 4.5% 5.4% +0.9% Vicodin/Lortab 7.2% 8.9% +1.7% Codeine 2.6% 2.7% +0.1% Hydrocodone 2.9% 4.0% +1.1% OxyContin 1.4% 2.4% +1.0% Morphine 1.0% 1.2% +0.2% Prevalence and Patterns of Nonmedical Use of OxyContin and Other Pain Relievers,ages 12 or older. SOURCE: SAMHSA, OAS, NSDUH, 2010 results. 50 Treatment Admissions for Opioid Addiction 17

18 Number of Admissions 350, , , , , ,000 50,000 0 Heroin & Other Opioid Treatment Admissions TEDS admissions for primary opioid abuse increased from 16% of all admissions in 1997 to 19% in Admissions for other opioids have increased consistently since the late 1990s 1% to 5% between 1997 and Heroin Other Opiates (SAMHSA, OAS, TEDS, 2009). Percent of All Admissions Treatment Admissions for Primary Heroin and Prescription Medication Abuse: U.S., % % Heroin Opiates/Synthetics Stimulants Tranquilizers Sedatives/Hypnotics SOURCE: SAMHSA, Treatment Episode Data Set, 2009 results. 53 National Treatment Admissions for Heroin and Other Opiates in Percentage of Treatment Admissions by Age Heroin Other Opiates (SAMHSA, OAS, TEDS, 2009) 18

19 Who Enters Treatment for Heroin Abuse? 68% male 53% non Hispanic White; 22% Hispanic; 22% non Hispanic Black 64% injected; 32% inhaled Average age at admission 36 years 71% used heroin daily (SAMHSA, OAS, TEDS, 2009) Who Enters Treatment for Heroin Abuse? 51% of patients entering treatment for heroin abuse primary heroin abuse in 2007 had at least one prior treatment episode; 26% had 5+ prior episodes 29% had a treatment plan that included medicationassisted opioid therapy 65% reported secondary drug use cocaine 51% alcohol 18% marijuana 11% (SAMHSA, OAS, TEDS, 2009) Who Enters Treatment for Other Opioid Abuse? (Non prescription use of methadone, codeine, morphine, oxycodone, hydromorphone, opium, etc.) 53% male 88% non Hispanic White; 4% Hispanic; 4% non Hispanic Black 72% administered opiates orally; 16% inhaled; 10% injected Average age at admission 32 years 20% had a treatment plan that included medication assisted opioid therapy 63% reported secondary drug use alcohol 22% marijuana 22% cocaine 18% (SAMHSA, OAS, TEDS, 2009). 19

20 Primary Heroin Treatment Admissions vs. Primary Other Opiate Treatment Admissions: A Side-by-Side Comparison Percent of Admissions 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% % Male % White % Injected % Rec'd Medication Heroin Admissions Other Opiate Admissions (SAMHSA, OAS, TEDS, 2009) Four Reasons for Not Entering Opioid Treatment 1. Limited treatment options Methadone or Naltrexone Drug Free Programming 2. Stigma 1. Many users don t want methadone It s like going from the frying pan into the fire Fearful of withdrawing from methadone 2. Concerned about being stereotyped 3. Settings have been highly structured 4. Providers subscribe to abstinence based model N.I.M.B.Y. Syndrome Methadone clinics are great, but Not In My Back Yard New opioid treatment programs are difficult to open. Zoning regulations and community reaction often create delays or prevent programs from opening. 20

21 A Need for Alternative Options Move outside traditional structure to: Attract more patients into treatment Expand access to treatment Reduce stigma associated with treatment Buprenorphine is a potential vehicle to bring about these changes. Module I - Summary Use of medications as a component of treatment can be an important in helping the person to achieve their treatment goals. DATA 2000 expands the options to include both opioid treatment programs and the general medical system. Opioid addiction affects a large number of people, yet many people do not seek treatment or treatment is not available when they do. Expanding treatment options can make treatment more attractive to people; expand access; and reduce stigma. Review of Opioid Pharmacology, Buprenorphine Treatment, and the Role of the Multidisciplinary Treatment Team 21

22 Opioid Addiction and the Brain Opioids attach to specific receptors in the brain called mu receptors. Activation of these receptors causes a pleasure response. Repeated stimulation of these receptors creates a tolerance requiring more drug for same effect. Buprenorphine: An Exciting New Option Buprenorphine Research Outcomes Buprenorphine is as effective as moderate doses of methadone (Fischer et al., 1999; Johnson, Jaffee, & Fudula, 1992; Ling et al., 1996; Schottenfield et al., 1997; Strain et al., 1994). Buprenorphine is as effective as moderate doses of LAAM (Johnson et al., 2000). Buprenorphine's partial agonist effects make it mildly reinforcing, encouraging medication compliance (Ling et al., 1998). After a year of buprenorphine plus counseling, 75% of patients retained in treatment compared to 0% in a placebo plus counseling condition (Kakko et al., 2003). 22

23 The Role of Buprenorphine in Opioid Treatment Partial Opioid Agonist Produces a ceiling effect at higher doses Has effects of typical opioid agonists these effects are dose dependent up to a limit Binds strongly to opiate receptor and is long acting Safe and effective therapy for opioid maintenance and detoxification Partial vs. Full Opioid Agonist and Antagonist Full Agonist (e.g., methadone) Opioid Effect Partial Agonist (e.g. buprenorphine) Dose of Opioid Antagonist (e.g. naloxone) 68 Patient Selection Counselors can screen and recommend patients for referral to qualified physicians. Physicians will consider the following questions: Is the patient currently addicted to opioids? Is buprenorphine the best medication? Is the office the best setting for treating the patient? 23

24 Patient Selection Assessment Questions Is the patient addicted to opioids? Is the patient aware of other available treatment options? Does the patient understand the risks, benefits, and limitations of buprenorphine treatment? Is the patient expected to be reasonably compliant? Is the patient expected to follow safety procedures? Patient Selection: Assessment Questions Is the patient psychiatrically stable? Is the patient taking other medications that may interact with buprenorphine? Are the psychosocial circumstances of the patient stable and supportive? Is the patient interested in office based buprenorphine treatment? Are there resources available in the office to provide appropriate treatment? Issues Requiring Consultation with the Physician Dependence upon high doses of benzodiazepines or other CNS depressants Significant psychiatric co morbidity Multiple previous opioid treatment episodes with frequent relapse 24

25 Issues Requiring Consultation with the Physician High level of dependence on high doses of opioids High risk for relapse based on psychosocial or environmental conditions Pregnancy Poor support system Issues Requiring Consultation with the Physician HIV and STDs Hepatitis or impaired liver function Issues Requiring Consultation with the Physician Use of alcohol Use of sedative hypnotics Use of stimulants Poly drug addiction 25

26 General Counseling Issues Confidentiality Urine toxicology testing Working with, not against, medication Psychosocial treatment Supporting medication maintenance Patient comfort during withdrawal

27 FREE Self Paced Courses CEUs Available ($5/hour) NASW NBCC NAADAC CME/CNE 79 Psychotherapeutic Medications Online & Mobile View + Mobile View Compatible across systems (i.e., device-agnostic) 80 What concepts from this presentation can I apply in my agency? What concepts from this presentation I am already applying in my agency? 27

28 Thank You! Let us rise up and be thankful, for if we didn't learn a lot today, at least we learned a little, and if we didn't learn a little, at least we didn't get sick, and if we got sick, at least we didn't die; so, let us all be thankful. Buddha Evaluation 28