Opioid Dependence: A Chronic, Relapsing Brain Disease

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1 Opioid Dependence: A Chronic, Relapsing Brain Disease

2 Presentation Objectives Review the evidence that opioid dependence is a chronic, relapsing disease Demonstrate similarities of opioid dependence to other chronic diseases Emphasize the importance of accepting the chronic disease model as an integral part of providing quality patient care and protecting access to treatment

3 Features of a Chronic, Relapsing Condition Limited chances of complete cure or recovery Relapse common Multifactorial Genetic (heritable vulnerability) Environmental (exposure) Biological (demonstrated pathophysiology) Behavioral (lifestyle aspects) Optimal patient care depends on accepting opioid dependence as a chronic, relapsing condition

4 No Universally Accepted Definition of Addiction National Institute on Drug Abuse (NIDA) A chronic, relapsing brain disease characterized by compulsive drug-seeking and use despite harmful consequences and by long-lasting structural and functional changes in the brain 1 Other definitions exist, but all agree that addiction is: Chronic 2,3 Relapsing 3,4 Progressive 3,4 Compulsive 2,4 1. National Institutes of Health National Institute on Drug Abuse. Accessed July 7, Robinson TE, Berridge KC. Brain Res Rev.1993;18(3): O Brien CP, McLellan AT. Lancet. 1996;347(8996): McLellan AT et al. JAMA. 2000;284(13):

5 Similarities to Other Chronic Diseases 1-3 Characteristics Drug Dependence Diabetes, Asthma, and Hypertension Well studied Chronic disorder Predictable course Effective treatments Curable NO NO Heritable Requires continued care Requires adherence to treatment Requires ongoing monitoring Influenced by behavior Tends to worsen if untreated 1. McLellan AT et al. Addiction. 2005;100(4): ; 2. McLellan AT et al. JAMA. 2000;284(13): ; 3. McLellan AT. Addiction. 2002;97(3):

6 Patients Who Relapse (%) Relapse Rates Are Similar to Other Chronic Diseases 1, % 70% 50% 70% 40% 60% 30% 50% Drug Addiction Type 1 Diabetes Hypertension Asthma 1. McLellan AT et al. JAMA. 2000;284(13): ; 2. National Institute on Drug Abuse. Accessed June 30, 2011.

7 Opioid Dependence Causes Changes in Brain PET scan images The lack of red in the opioid-dependent brain shows that chronic opioid use has reduced dopamine receptor concentration Wang GJ et al. Neuropsychopharmacology. 1997;16(2):

8 Benefits of the Chronic Disease Model Emphasizes comprehensive, sustained treatment to help retain patients, maintain adherence, and focus on success Minimizes stigma associated with opioid dependence Promotes continuity of care Underscores the importance of ongoing monitoring Reinforces the need for a multifaceted, multidisciplinary treatment approach van den Brink W et al. Can J Psychiatry. 2006;51(10):

9 The Multifaceted Components of Opioid Addiction

10 The Multiple Components of Drug Abuse Drug abuse has multiple components: Neurobiologic 1,2 Behavioral, cognitive, and affective Treatment must address each component Drug abuse is learned 3,4 Long-term drug use alters: The way people think about their own behavior 5 Emotional reactions to environmental stimuli 5 1. Koob GF, Le Moal M. Neuropsychopharmacology. 2001;24(2):97-129; 2. Kalivas PW, Volkow ND. Am J Psychiatry. 2005;162(8): Hesselbrock MN et al. Addictions, A Comprehensive Guidebook. New York, NY: Oxford University Press; 1999: Irvin JE et al. J Consult Clin Psychol. 1999;67(4): Larimer ME et al. Alcohol Res Health. 1999;23(2):

11 Neurobiological Aspects: The Cycle of Addiction 1,2 Acute reinforcing effects Tolerance and withdrawal Craving and relapse 1. Koob GF, Le Moal M. Neuropsychopharmacology. 2001;24(2):97-129; 2. Kalivas PW, Volkow ND. Am J Psychiatry. 2005;162(8):

12 Chemical Changes: Craving and Relapse 1,2 Long-term changes in brain responsivity may remain even after withdrawal and sustained abstinence Drug- and cue-induced craving are associated with activation of critical brain regions Patients may always be at risk for craving and relapse upon re-exposure to the drug or environmental cues associated with the drug Orbitofrontal cortex Anterior cingulate Nucleus accumbens Ventral tegmental area 1. Hommer DW. Alcohol Res Health.1999;23(3): ; 2. Volkow ND, Fowler JS. Cerebral Cortex. 2000;10(3):

13 Behavioral Components of Addictive Behavior Within a behavioral framework, drug use is viewed as a special case of operant behavior maintained by the reinforcing effects of the drug 1 Learned behavior Disrupt any element to reduce strength of behavior 2 3-Term Contingency Antecedent Behavior Consequence Drug reinforcement Drugs of abuse function as positive reinforcers in laboratory studies and therapeutic utility of pharmacotherapies can be demonstrated in laboratory studies 3,4 Extinction 2 When responses no longer produce reinforcement, their rate diminishes Initial response to extinction is a rate increase; some behaviors are resistant 1. Bigelow GE et al. Addict Behav. 1981;6(5): ; 2. Skinner BF. Science and Human Behavior. New York, NY: Macmllian; 1953; 3. Katz JL, Goldberg SR. Agents Actions. 1988;23(1-2):18-26; 4. Haney M, Spealman R. Psychopharmacology (Berl). 2008;199(3):

14 Multifaceted Treatment Approach

15 Treatment Goals Retain patients Minimize withdrawal symptoms and cravings Provide psychosocial support

16 The Components of Treatment: Pharmacotherapy and Psychosocial Intervention 1,2 Pharmacotherapy Can control symptoms by normalizing brain chemistry Psychosocial Intervention Essential to change behaviors and responses to environmental and social cues that so significantly impact relapse Both are necessary to normalize brain chemistry, change behavior, and reduce risk for relapse; neither alone is sufficient 1. McLellan et al. Addiction. 1998;93(10): ; 2. McLellan et al. JAMA. 1993;269(15):

17 Buprenorphine and Naloxone Combination Treatment: Opioid Use Urine Samples Negative for Drugs (%) In a four-week, double-blind placebo-controlled trial, the proportion of opiate-negative urine samples was significantly greater for patients on active treatment (17.8%) vs placebo (5.8%; P<.001) Percentage of NEGATIVE Urine Samples Opiates No. of Samples Tested For opiates Weeks Fudala PJ et al. N Engl J Med. 2003;349(10): Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

18 Efficacy of Buprenorphine and Naloxone Treatment: Craving Opiate Craving Scores Buprenorphine-naloxone Placebo Mean opiate craving scores were significantly lower for patients on active treatment vs placebo at all time points (P<.001) Fudala PJ et al. N Engl J Med. 2003;349(10): Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

19 Long-Term Treatment Is Associated With Positive Outcomes Patients (n=5577) receiving medication-assisted therapy with either methadone or buprenorphine in the United Kingdom Probability That Treatment Reduces Overall Mortality Cornish R et al. BMJ. 2010;341:c5475. Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

20 Prolonged Medication-Assisted Treatment Sustains Improvement 4 Studies of Various Treatment Lengths After 6 Months 1 (buprenorphine-only; n=690) Heroin use decreased by 81% Codeine use decreased by 83% Benzodiazepine use decreased by 48% Cocaine use decreased by 74% After 18 Months 3 (buprenorphine/naloxone; n=176) Less likely to report using any substance or heroin More likely to be employed Improved on several psychosocial parameters After 12 Months 2 (buprenorphine-only; n=40) 32% improvement in occupational problems 90% improvement in drug-related problems 90% improvement in crime-related problems After 2-5 Years 4 (buprenorphine/naloxone; n=53) 91% of urine samples were opioid negative 96% of urine samples were cocaine negative 1. Lavignasse P et al. Ann Med Interne (Paris). 2002:153(suppl 3):1S20-1S26; 2. Kakko J. Lancet. 2003;361(9358): ; 3. Parran TV et al. Drug Alcohol Depend. 2010:106(1):56-60; 4. Fiellin DA et al. Am J Addict. 2008;17(2): Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

21 SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII) Label: Psychosocial Counseling Safety and efficacy data for SUBOXONE are derived from studies that all used SUBOXONE (or buprenorphine/naloxone combination) in conjunction with psychosocial counseling as part of a comprehensive addiction treatment program. In order to qualify to prescribe SUBOXONE, physicians must have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy. (FDA Physician Information) [http://suboxone.com/pdfs/suboxonepi.pdf] Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

22 Counseling Improves Outcomes: Opioid Dependence Most recent updates of Cochrane Database reviews of pharmacological interventions for opioid dependence and medical taper with and without psychosocial treatment Opioid dependence: Adding psychosocial support to medicationassisted treatments improves the number of participants abstinent at follow-up 1 Medical taper: Adding psychosocial support to medical taper improves treatment completion and decreases opioid use 2 1. Amato L et al. Cochrane Database Syst Rev. 2008;(4):CD doi: / CD pub3; 2. Amato L et al. Cochrane Database Syst Rev. 2008;(4):CD doi: / CD pub3.

23 Counseling Improves Outcomes: Opioid Dependence Intravenous opiate users were assigned to one of three treatments: Minimum methadone services (MMS; drug alone) Standard methadone services (SMS; drug + counseling) Enhanced methadone services (EMS; drug + counseling + onsite psychosocial interventions) Outcomes were significantly better for the EMS group overall (EMS > SMS > MMS) The figure shows the percentage of subjects in each group with consecutive opiate-free urine samples ( dose response for psychosocial services) McLellan AT et al. JAMA. 1993;269(15):

24 Psychotherapy, Counseling, or Psychosocial Support Improves Outcomes in Other Chronic Diseases Depression Addition of psychotherapy following initial pharmacological control of acute symptoms of major depressive disorder confers advantage in terms of relapse 1-3 Panic disorder Combined pharmacotherapy and psychotherapy is significantly superior to pharmacotherapy alone 4 Nicotine dependence Provision of more intense levels of psychosocial support can facilitate likelihood of quitting 5,6 Alcohol dependence Advantages of combining psychotherapy with pharmacotherapy were not apparent during active therapy, but emerged after therapy ended 6,7 Obesity In the absence of a psychosocial intervention aimed at lifestyle change, weight loss achieved through pharmacotherapy is not sustained 8 1. Petersen TJ et al. J Psychopharmacol. 2006;20(suppl 3):19-28; 2. Nierenberg AA et al. J Clin Psychiatry. 2003; 64(suppl 15):13-17; 3. Trivedi MH et al. Psychopharmacol Bull. 2008;41(4):5-33; 4. Zwanzger P et al. J Neural Transm. 2008;116(6) ; 5. Stead LF et al. Cochrane Database Syst Rev. 2008;(1):CD doi: / CD000146; 6. Doran CM et al. Addict Behav. 2006;31(11): ; 7. Donovan DM et al. J Stud Alcohol Drugs. 2008;69(1):5-13; 8. Woo J et al. J Eval Clin Pract. 2007;13(6):

25 Defining Counseling and Behavioral Therapy for Opioid-Dependence Treatment Encompasses several types of treatment modalities Counseling/psychotherapy, including cognitive behavioral therapy Community-based support (12-step programs, Alcoholics Anonymous [AA]/Narcotics Anonymous [NA]) Other social support (financial, housing, life skills) Treatment should be individualized to address the unique constellation of factors that impacts each patient s condition Dependence history Comorbidities Existing social network Socioeconomic status Psychosocial support may continue beyond pharmacotherapy to aid in relapse prevention 1. Marlatt A, Gordon R. Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors. New York, NY: Guilford; 1985; 2. McKay JR et al. J Consult Clin Psychol. 1997;65(5):

26 Summary Opioid dependence is a chronic, relapsing disease similar to other chronic diseases Medication-assisted maintenance treatment is the standard Treatment is not time limited The disease is multifaceted with neurobiologic and behavioral components Requires a multifaceted treatment approach Combining pharmacotherapy and psychosocial interventions is critical to treat the multiple facets of the disease

27 Important Safety Information

28 Important Safety Information SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act. SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone. SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient s level of stability is essential. Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset. SUBOXONE Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered. Liver function should be monitored before and during treatment. Please see full Prescribing Information available at this presentation.

29 Important Safety Information (cont) Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants. Children who take SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII) can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children. Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms. Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment. Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision. Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported. This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list. Please see full Prescribing Information available at this presentation.

30 Important Safety Information (cont) To report an adverse event associated with taking SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII), please call You are encouraged to report adverse events of prescription drugs to the FDA. Visit or call FDA Please see full Prescribing Information available at this presentation.

31 Prescribing Information SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA). Under the Drug Addiction Treatment Act, prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. SUBOXONE Film should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported. Please see Important Safety Information on slides and full Prescribing Information available at this presentation.

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