Addressing Opiate Abuse

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1 Addressing Opiate Abuse William B. Lawson, MD, PhD, DLFAPA Associate Dean of Health Disparities University of Texas at Austin Dell Medical School

2 Opioids Medications that relieve pain Reduce the intensity of pain signals reaching the brain and affect those brain areas controlling emotion, which diminishes the effects of a painful stimulus In addition to their pain relieving properties, some of these drugs codeine and diphenoxylate (Lomotil) for example can be used to relieve coughs and severe diarrhea

3 Opiates & Opioids Opiates = naturally present in opium e.g. morphine, codeine, thebaine Opioids = manufactured Semisynthetics are derived from an opiate heroin from morphine buprenorphine from thebaine Synthetics are completely man-made to work like opiates methadone

4 This class includes : Hydrocodone (e.g., Vicodin) Oxycodone (e.g., OxyContin, Percocet) Morphine (e.g., Kadian, Avinza) Codeine Heroin Methadone

5 The problem According to the (CDC), in 2012, US providers wrote 259 million prescriptions for painkillers, enough for every American adult to have a bottle of pills. The CDC also reports that 46 Americans die every day from overdosing on prescription painkillers.

6 Pain Relief and Euphoria

7 Who Gets Addicted? Jamie Fox Rush Limbaugh Whitney Houston Robin Williams Prince?

8 Use Among Youngsters Children s Safety Network. Texas 2015 Fact Sheet.

9 Consequences

10 Neurotoxicity AIDS, Cancer Mental illness Homelessness Crime Violence Health care Productivity Accidents

11 HIV and Hepatitis Injection drug use and needle sharing are responsible for about 10% of HIV cases annually, and one in six people with HIV/AIDS have used an illegal drug intravenously in their lifetime Co-infection with hepatitis C occurs in a quarter of Americans living with HIV. Among injection drug users and needle sharers, rates of co-infection are even higher (80%). Most people with hepatitis C are unaware of their infection and, for many, this can result in significant damage to the liver including the development of life-threatening conditions such as cirrhosis or hepatocellular carcinoma. Among people living with HIV, liver disease due to hepatitis C is the most common cause of non-aids related death.

12 Why Do Some People Use Drugs? To feel good To have novel: feelings sensations experiences AND to share them To feel better To lessen: anxiety worries fears depression hopelessness

13 Addiction A chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences. It is considered a brain disease because drugs change the brain they change its structure and how it works. These brain changes can be long-lasting, and can lead to the harmful behaviors seen in people who abuse drugs. severe substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5, 2013).

14 Dependence vs. Addiction Physical dependence occurs because of normal adaptations to chronic exposure to a drug and is not the same as addiction. Addiction, which can include physical dependence, is distinguished by compulsive drug seeking and use despite sometimes devastating consequences. Someone who is physically dependent on a medication will experience withdrawal symptoms when use of the drug is abruptly reduced or stopped. These symptoms can be mild or severe (depending on the drug) and can usually be managed medically or avoided by using a slow drug taper. Dependence is often accompanied by tolerance, or the need to take higher doses of a medication to get the same effect. When tolerance occurs, it can be difficult for a physician to evaluate whether a patient is developing a drug problem, or has a real medical need for higher doses to control their symptoms..

15 Drugs Are Usurping Brain Circuits And Motivational Priorities

16 Circuits Involved In Drug Abuse and Addiction All of these must be considered in developing strategies to effectively treat addiction

17 Key area: nucleus acumbens

18 % of Basal DA Output DA Concentration (% Baseline) Natural Rewards Elevate Dopamine Levels 200 FOOD NAc shell 200 SEX Empty Box Feeding Time (min) 100 Sample Number Female Present Copulation Frequency Mounts Intromissions Ejaculations Di Chiara et al., Neuroscience, Fiorino and Phillips, J. Neuroscience, 1997.

19 Dopamine D2 Receptors are Lower in Addiction DA DA Cocaine DA DA DA DA DA DA DA DA DA DA Meth Reward Circuits Non-Drug Abuser DA DA Alcohol DA DA DA DA Heroin Control Addicted Reward Circuits Drug Abuser

20 Effects of Drugs on Dopamine Release Di Chiara and Imperato, PNAS, 1988

21

22 The Chemistry Described as a central nervous system disorder, opiate addiction results when prolonged opiate use leads to damage of the sensory nerves and the brain which causes cells to stop producing endorphins. Medically termed endogenous opiates, endorphins are naturally occurring painkillers that, in a nonopiate abuser, stop pain by blocking the nerve perception of the pain.

23 Consequences Prolonged opiate use will lead to nerve damage that results in an inability for the body to cope with or stop pain. Damage to the nerves result a reduced or completely eliminated production of endorphins and as a result, the user is unable to mask pain. Over time, nerve cells continue to degenerate to an extent that the user requires opiates in order to feel comfortable and to prevent extreme bodily pain. This resulting damage to the nerves that stops endorphin production and causes a dependence on opiates to produce similar effects is known as opiate addiction.

24 Opiate Sites of Action

25 Drug addiction is a chronic illness with relapse rates similar to those of hypertension, diabetes, and asthma McLellan et al., JAMA, 2000.

26 Percent of Patients Who Relapse 40 to 60% 30 to 50% 50 to 70% 50 to 70% Relapse Rates Are Similar for Drug Addiction & Other Chronic Illnesses Drug Addiction McLellan et al., JAMA, Type I Diabetes Hypertension Asthma

27 The Drug Abuse Treatment Outcome Study (DATOS) outpatient methadone outpatient drug-free long-term residential short-term inpatient

28

29 CORRECTIONAL SYSTEMS The large-scale incarceration of drug users has resulted in a disproportionate rate of infection and burden of HIV/AIDS among the prison population, and correctional facilities have emerged as critical settings for interventions to prevent, diagnose, and treat HIV and other infectious diseases.

30 Report: Treating Drug Users to Reduce Crime Cuts drug abuse in half Reduces criminal activity up to 80 percent Reduces arrests up to 64 percent Reduces the spread of HIV/AIDS, hepatitis, and other infectious diseases Treatment was greatly enhanced by drug court and buprenorphine programs NIH Record. NIDA Recommends Treating Drug Abusers To Save Money, Reduce Crime. September 8, Tim Bell former offender and Substance User Dr. Volkow unveils new report

31 Non Medical Treatments Cognitive Behavioral Therapy seeks to help patients recognize, avoid, and cope with the situations in which they are most likely to abuse drugs. Contingency Management uses positive reinforcement such as providing rewards or privileges for remaining drug free, for attending and participating in counseling sessions, or for taking treatment medications as prescribed. Motivational Enhancement Therapy uses strategies to evoke rapid and internally motivated behavior change to stop drug use and facilitate treatment entry. Family Therapy (especially for youth) approaches a person s drug problems in the context of family interactions and dynamics that may contribute to drug use and other risky behaviors.

32 Medication Assisted Therapy Opioid Addiction Methadone Buprenorphine Naltrexone

33 MAT The cravings and withdrawal symptoms associated with quitting opiate use are very strong and difficult to overcome. It is for this reason that medication-assisted treatments are often recommended. These therapies address the changes that drugs have caused in a user s brain, according to the National Institute on Drug Abuse. The most common drugs used to treat opioid addiction and dependence are opioid agonists or partial opioid agonists, which interact with and activate the opiate receptors in the brain

34 Methadone Clinics & MMT One of the most common ways of overcoming opiate addiction is to seek treatment in a methadone clinic or through methadone maintenance treatment. Methadone maintenance treatment involves being administered a dosage of methadone each day which will counteract the withdrawal symptoms by tricking the body into believing that it is still using heroin or other opiates.methadone maintenance is most effective when combined with counseling and therapy.

35 About Buprenorphine Therapy In October 2002, the Food and Drug Administration (FDA) approved buprenorphine monotherapy product, Subutex, and a buprenorphine/naloxone combination product, Suboxone, for use in opioid addiction treatment. The combination product is designed to decrease the potential for abuse by injection. Subutex and Suboxone are currently the only Schedule III, IV, or V medications to have received FDA approval for this indication.

36 The Case for Buprenorphine 36 The spread of HIV in the U.S. is fueled in part by the use of illicit drugs. Injection drug use is directly related to HIV transmission through the sharing of drug equipment The use of both injected and noninjected drugs impairs decision-making and increases sexual risk-taking behavior, which increases the risk for acquiring HIV. Even though substance abuse treatment is crucial for staying in HIV care and adhering to a treatment regimen, it is in short supply. The introduction of buprenorphine offers hope for improved access to treatment for addiction. Source: Health Resources and Services Administration, Substance Abuse and HIV/AIDS In the United States, June 2006, retrieved 2/15/08

37 Methadone Vs Buprenorphine Methadone No Ceiling Can top off when in treatment Can take months to titrate does up or down Diversion or mis- used Provided in specialized treatment centers Mulitple side effects at theraupeutic doses including sedation Depressogenic? Buprenorphine Ceiling does of 32mg Blockade effect, limiting the effects of additional opioid use High Safety profile Low potential for abuse and diversion Provided Minimal side effects Putative antidepressant effect

38 Buprenorphine s Properties Is a synthetic opioid Partial agonist: Less reinforcing than a full agonist But more acceptable to patients than a full antagonist Easier withdrawal Safety overdose ceiling effect Friedman_march 2005

39 Partial Agonist Activity Levels % Receptor Intrinsic Activity no drug low dose DRUG DOSE Full Agonist (e.g. heroin) At higher doses, even when partial agonist binds all receptors, maximal agonist effect is never achieved Partial Agonist (e.g. buprenorphine) Like full agonists, partial agonist drugs increase activity at lower doses high dose

40 Percent of Patient Sample Buprenorphine Patient Outcomes: Specific Criminal Activities 20% 15% In the past 30 days were you involved in any of the following activities? 16% Baseline 30 Day 6 Month 10% 10% 10% 5% 0% 3% 2% 1% 1% 1% 1% Drug Dealing Prescription Fraud Other Crimes Source: SAMHSA Patient Longitudinal Study, November 2005 n=37 9

41 Mean Days in Last 30 Buprenorphine Patient Outcomes: Acquisition of Drugs on the Street In the past 30 days, how many days did you get drugs on the street? Baseline 30 Day Followup 6 Month Followup Source: SAMHSA Patient Longitudinal Study, November 2005

42 Percent of Patient Sample Buprenorphine Patient Outcomes: Percent of Patients Acquiring Drugs on the Street 100% 80% 60% 67% 40% 20% 0% 4% 20% Baseline 30 Day Followup 6 Month Followup Source: SAMHSA Patient Longitudinal Study. November 2005

43 Percent of Patient Sample Patient Report of Counseling Sessions: First 30 Days of Buprenorphine Treatment 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 41% 12% 8% 10% 10% 4% 6% 4% 3% 2% Number of Counseling Sessions per Patient Source: Evaluation of the Buprenorphine Waiver Program, conducted by SAMHSA/CSAT from n=34 7 4

44 How to Obtain a Waiver Physician Waiver Qualifications The Drug Addiction Treatment Act of 2000 (DATA 2000) enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substances Act for the provision of medication-assisted opioid therapy. This waiver allows qualifying physicians to practice medication-assisted opioid addiction therapy with Schedule III, IV, or V narcotic medications specifically approved by the Food and Drug Administration (FDA). On October 8, 2002 Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) received FDA approval for the treatment of opioid addiction. To receive a waiver to practice opioid addiction therapy with approved Schedule III, IV, or V narcotics a physician must notify the Center for Substance Abuse Treatment (CSAT, a component of the Substance Abuse and Mental Health Services Administration) of his or her intent to begin dispensing or prescribing this treatment. This Notification of Intent must be submitted to CSAT before the initial dispensing or prescribing of opioid therapy. The waiver notification section on this Site provides information on how to obtain and submit a Notification of Intent form. The Notification of Intent can be submitted on-line from this Web site, or via ground mail or fax. The Notification of Intent must contain information on the physician s qualifying credentials (as defined below) and additional certifications including that the physician has the capacity to refer such addiction therapy patients for appropriate counseling and other non-pharmacologic therapies, and that the physician will not have more than 30 patients on such addiction therapy at any one time for the first year. (Note: The 30-patient limit is not affected by the number of a physician s practice locations. One year after the date on which the physician submitted the initial notification, the physician will be able to submit a second notification stating the need and intent to treat up to 100 patients.) The Drug Enforcement Administration (DEA) assigns the physician a special identification number. DEA regulations require this ID number to be included on all buprenorphine prescriptions for opioid addiction therapy, along with the physician s regular DEA registration number.

45 WAIVER DATA 2000, part of the Children s Health Act of 2000, permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the Food and Drug Administration (FDA) including buprenorphine in treatment settings other than OTPs. The Act permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act 1974 (PDF 437 KB) to treat opioid dependency with Schedule III, IV, and V medications or combinations of such medications that have been approved by FDA for that indication. Learn more about buprenorphine to treat substance use disorders.

46 WAIVER Physicians can complete the online Waiver Notification Form SMA-167 or download, complete, and fax Waiver notification Form SMA-167 (PDF 62 KB) to

47 Buprenorphine, Health Disparities and Diversion Lack of access to physician services may be contributing to the diversion and abuse of buprenorphine Financial barriers keep some patients from being able to get their own prescription from a physician Limited number of prescribers may also be a factor. Patients selling their buprenorphine to others dependent on opioids may not hesitate to sell their drugs to non-opioid dependent users. 47

48 Going Forward Last October, AAAP along with AMA, AOA, ADA and many other medical, osteopathic, dental, and other health professional organizations committed collectively to reduce opioid overdose deaths and more effectively treat opioid use disorders. Key measures of our success over the next two years include: Having more than 540,000 health care providers complete opioid prescriber training; Doubling the number of physicians certified to prescribe buprenorphine for opioid use disorder treatment; Doubling the number of providers who prescribe naloxone--a drug that can reverse an opioid overdose; Doubling the number of health care providers registered with their State Prescription Drug Monitoring Programs

49 Treating a Biobehavioral Disorder Must Go Beyond Just Fixing the Chemistry Pharmacological (medications) Behavioral Therapies Medical and Social Services

50 Drug Rehabilatation Some people do not want to go forward with only medicationassisted therapy and therefore do not wish to take part in a methadone maintenance program. For those who decide not to quit cold turkey but also not to take part in a medication replacement program, drug rehab is an option. Drug rehab involves a combination of medical intervention, monitoring, peer support and counseling to effectively help patients overcome opiate addiction. Many drug rehab programs do utilize methadone maintenance of Suboxone, but most provide alternatives that are also effective at helping patients get past the strongholds of opiate addiction and move on with their lives.

51 About SBIRT An Early Intervention Approach The SBIRT Initiative represents a paradigm shift in the provision of treatment for substance use and abuse. The services are different from, but designed to work in concert with, specialized or traditional treatment. New Target Population The primary focus of specialized treatment has been persons with more severe substance use or those who have met the criteria for a Substance Use Disorder. The SBIRT Initiative targets those with nondependent substance use and provides effective strategies for intervention prior to the need for more extensive or specialized treatment. System for Assessment, Intervention, and Treatment The Initiative involves implementation of a system within community and/or medical settings including physician offices, hospitals, educational institutions, and mental health centers that screens for and identifies individuals with or at-risk for substance use-related problems. Screening determines the severity of substance use and identifies the appropriate level of intervention. The system provides for brief intervention or brief treatment within the community setting or motivates and refers those identified as needing more extensive services than provided in the community setting to a specialist setting for assessment, diagnosis, and appropriate treatment. Approach is Successful As of August 2007, SBIRT grantees funded by SAMHSA have screened over 536,000 individuals. Through grantees efforts, researchers are learning how to integrate SBIRT into primary care. Preliminary data suggest the approach is successful in modifying the consumption/use patterns of those who consume five or more alcoholic beverages in one sitting and those who use illegal substances. These grantees have implemented SBIRT in trauma centers/emergency rooms, community clinics, federally qualified health centers, and school clinics.

52 Treat the Whole Person! No single Treatment is appropriate for all individual Treatment must attend to multiple needs of the individual Remaining in treatment for adequate time is vital for success Treatment should be readily available no matter race, gender, orientation, or socio-economic status

53 We Are Getting There Slowly but Surely!

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