Aryeh Levenson, M.D. alevenson@scf.cc (ext 8597) March 26, 2012 SUBOXONE PROGRAM:
Opiate Addiction: History First seriously emerged iatrogenically with Civil War vets By late 19 th century, 2/3 of all those addicted were white middle-upper class Historically used for Menstrual symptoms Used as a cure in sanitoriums Above populations did not create social problem, but showed same characteristics of relapse/craving as current addicts
Opiate Addiction: history Heroine introduced 1898 as cough suppressant Hyperdermic technique introduced into medicine in 1910 s. Harrison Act of 1914: Restricted prescriptions of opiates for other than pain By 1920 s population of opiate addicts change: Now young immigrant males Crime rates skyrocket
Opiate Addiction - History 1929: Congress authorizes first treatment facilities Failure rates from 86%-97% During WWII (1940 s) numbers of addicts plummets due to disruption of shipping By 1960 s # s of addicts increase in inner cities and rise in white middle class Commitment laws enacted for addicts (up to 3 years). Same high failure rate
Opiate Addiction - history Civil Commitment Enacted due to fears about addiction related crimes Up to 3 years Very expensive, failure rates above 80% Discontinued
Opiate Addiction: History Numbers of addicts, associated crimes, and deaths skyrocket. E.gNYC: opiate related deaths #1 cause for 15-35 year olds During Viet Nam 25%-50% of all soldiers developed an opiate addiction However, feared epidemic did not result upon their return 1980 s: 500,000 illicit opiate users 2000: 900,000 users
Origins of Buprenorphine (suboxone TX) Early Rationale: Extremely high rates of relapse led to search for alternative tx options Addicts universally reported severe cravings as cause Morphine, other short acting opiates high sedation, significant tolerance Methadone: 1960 s research indicated less euphoria, reduced cravings, no tolerance Supressed cravings for >24 hours
Origins of Buprenorphine (suboxone TX) 1965 first public Methadone program (NYC) Findings: reduction in relapse, better social outcomes, reduction in crime, increased employment. LAAM Levo-Alpha Acetyl Methadol Reduces cravings for 48-72 hours or longer Became preferred maintenance therapy Due to cardiac side effects, largely discontinued
Opiate Replacement Therapy Methadone Studies going back to the 1970 s show that Methadone treatment much more successful than non opiate replacement therapy Reduction in rates of disease transmission, crime, child morbidity, etc. Thus, instituted as a public health measure
Origins of Buprenorphine (suboxone TX) 1980 s Naltrexone (opiate antagonist) studied Results: block all opiates Does not lower cravings High relapse rate due to poor compliance
Origins of Buprenorphine (suboxone TX) 1990 s Methadone maint. Tx demonstrated: Cost beneficial (tax payer savings of $4 for every dollar of cost Superior to all other forms of treatment: E.g outpatient, IOP, residential, civil commitment Better vocational rehab, reduction of cravings, reduction of relapse, reduction of crime, reduction of diversion, reduction of hospitalization
Origins of Buprenorphine (suboxone TX) Due to regulations, Methadone tx only available through highly specialized programs Institute of Medicine research Federal regulations of Methadone tx inhibited in availability of treatment
In Anchorage, these numbers are likely lower than the national average Dramatic increase of Heroine use throughout the USA and Alaska Only 15-20% opiate abusers receive treatment
Scope of the problem ~ ½ million opiate addicts in country Use highly associated with HIV, Hep B and C transmission Use associated with unemployment, criminality, childhood mental health issues, etc. Estimated opiate addiction costs> $5 billion to society Significant neonatal impact to developing fetus
Scope of Problem Opiates are leading cause of substance related deaths in USA Heroine users have up to 30X death rate as non heroine users In Anchorage opiate dependence related to increase rates of prostitution High percentage of pregnant opiate abusers Long term users develop abstinence Syndrome
Scope of the Problem Differential characteristics of opiate dependence Ultra high relapse rate due to physiological effects of chronic opiate use
Treatment Effectiveness Regrettably standard Psycho-social treatment is less effective for Opiate addicts than addicts of any other substance Relapse rate after psychosocial treatment completion tops 90% Due to Neurophysiological CNS changes induced by High dose Opiate use E.g. Chronic withdrawal/abstinent state
Impact of Methadone tx Methadone decreases mortality by 70% Addicts who drop out of methadone treatment have 8X risk of death compared with those remaining in treatment Reduction in HIV, Hep C transmission Improvement of a number of public health measures Suboxone use reduces mortality by 80% (France)
Problems with Methadone Maintenance Methadone still has high abuse potential Extremely high requirements for certification limits the program availability Requires specialty liscencing Anchorage Methadone program often has 1 year wait list Poor community acceptance
2000 Drug Addiction Treatment Act authorizes use of Opiate maintenance in physician offices by PCP s Increased Availability It will reach more people. Increased Accessibility It will allow treatment to occur in places other than specialized clinics. Better Overall Treatment It will allow simultaneous and improved treatment for other commonly co-occurring medical conditions, such as hepatitis C and HIV.
Thus legislation Regarding use of Suboxone
QUALIFYING UNDER THE ACT 1. Be a licensed physician 1. Complete the required training 2. Obtain a DEA waiver 3. Have available resources to refer to substance abuse programs 4. Treat up to 30 patients during the first year 5. May apply to treat up to 100 patients thereafter 6. (Group practice can combine total number of patients and divide by number of providers to maintain numbers
Opiate pharmacology Mu Receptors Activation analgesia, sleepiness, reduced awareness, respiratory depression, gastrointestinal depression, pupillaryconstriction, and euphoria. Mu receptor activation is also highly reinforcing physically and psychologically, and result in dependence. -morphine, heroin, methadone, levo-alpha-acetyl-methadol, hydromorphone, buprenorphine, hydrocodone, oxycodone, codeine, and fentanyl. Kappa Receptor activation activation of kappa receptors produces analgesia, dysphoriaand aversion Delta Receptors activation Less studied: mediate the emotional aspects of opioid addiction
Opiate Withdrawal symptoms Withdrawal symptoms includes restlessness, weakness, chills, body and joint pains, gastrointestinal cramps, anorexia (loss of appetite), nausea, feelings of inefficiency, and social withdrawal. Severe Cravings: Jonesing Signs of withdrawal: activation of the autonomic nervous system, lacrimation (tearing eyes), rhinorrhea(running nose), piloerection (gooseflesh), tachypnea(rapid breathing), mydriasis (dilated pupils), hypertension (high blood pressure), tachycardia (rapid heart beat), muscle spasms, twitching, restlessness, vomiting, and diarrhea.
Opiate Abstinence Syndrome Chronic Opiate Abstinence Syndrome: Less intense chronic feelings of withdrawal includes restlessness, weakness, chills, body and joint pains, gastrointestinal cramps, anorexia (loss of appetite), nausea, feelings of inefficiency, and social withdrawal. Chronic cravings
Tolerance Vs. Dependence Vs. Abuse Tolerance: require to take more of the medication to get same clinical effect Dependence: sudden discontinuation of medication results in withdrawal symptoms Addiction: Maladaptive behaviors around the use of the substance
Abuse/Dependence (NOT DSM IV) Abuse E.g. Neglect of responsibilities due to use of substance Use of substance in dangerous situations (e.g. driving under influence) Use of substance leads to illegal activities Use of substance results in maladaptive behavior changes Dependence includes the above AND Tolerance/dependence AND Cravings of substance not due to underlying medical condition (e.g. pain)
Drug Seeking Behavior Mistaking Legitimate Users for Drug Misusers Situations in which legitimate narcotic users can be misidentified as drug misusers. Pseudo-addiction: Patients whose pain is undertreated may exhibit drug-seeking behaviors ("doctor shopping," etc.) to relieve their pain. Since these behaviors are also common among drug-abusers, can be mistaken as as addiction. However, pseudo-addicted patients legitimately need more analgesics to adequately treat their pain, and their behavior will stop once pain is adequately treated.
Drug Seeking Behaviors Therapeutic Dependence: concern about losing or interrupting access to pain medication (e.g., by losing or changing medical insurance, changing doctors) leads to opiate seeking behaviors These patients may try to create an emergency supply of medication that can cause legitimate users to be mistaken for drug misusers.
Buprenorphine or bust.. Orwhy use buprenorphine rather than Methadone
Opiate pharmacology Agonist: binds to receptor and activates receptor to do all the fun stuff opiates do. Antangonist: bind to receptor but does not activate. Blocks agonists Partial agonist: Binds to receptor with activation at lower doses, but activation quickly plateaus
BUPRENORPHINE (SUBOXONE) Two formulations: (Schedule III) Buprenorphine alone: Subutex Partial Agonist (now in generic) Used primarily in pregnancy Buprenorphine + Naloxone (Suboxone) -4:1 RATIO Naloxone is antagonist
Buprenorphine Buprenophine is partial agonist Relatively long therapeutic half-life (24-60 hours) Relatively mild withdrawal syndrome Low risk of overdose Preferentially binds to mu receptors over other agonists limits mu receptor activation Blocks effects of other opiates
Buprenorphine Poorly bioavailability orally fair sublingual bioavailability Good IV bioavailability Versus: Naloxone an Opiate Antagonist Good IV bioavailability Poor oral and sublngual bioavailability Thus Abuse of Suboxone will precipiate withdrawal
SCF Suboxone program Philosophy: Based on research, not on theory NOT BASED ON ABSTINANCE MODEL E.g. use of opiate replacement treatment Risk reduction model E.g. THC use Relapses
SCF Buprenorphine Suboxone Program Screening R/O contraindications Referral Refer to Suboxone clinic Pre-induction Establish diagnoses, prepare to start Buprenorphine Induction Start the medication Stabilization Get customer s life stable Maintenance Primary care to prescribe Buprenorphine Discontinuation stopping the medication
SCF suboxone Program Screening stage To R/O contraindications prior to referral Medical Provider Component R/o contraindications Provide physical exam Assess for medical comorbidities (e.g. hepatitis, TB, STDs, HIV, Abcesses, pregnancy, endocarditis, renal/pulmonary disease, head trauma
SCF suboxone Program Screening stage Behavioral Health clinician Component Screen out major psychiatric comorbiditiesthat will require additional MH referral Assess for motivation Assess for reliability Preliminary Opiate abuse/dependence screening Meet diagnosis of Opiate Abuse/Dependence (ICD 9 or DSM IV) Physical tolerance and/or dependence Recurrent use resulting in maladaptive interpersonal, vocational, physical, legal, family functioning REMEMBER: Pseudoaddictionis not Opiate Dependence
SCF Suboxone Program Referral Stage All referrals will come through PCP Whether or not generated by customer, SCF clinics, outside providers, etc After Screen all referrals will go to either Bonny Hughes or Tiffany Dushkin
SCF Suboxone Program Clinic stage Pre-induction Done by Psychiatrist Pre-induction Psychiatric screen/mental status exam by psychiatrist Development of wellness plan Referral to substance abuse program (DAC, CITC, etc) Referral to Suboxone group (Michael Yates) Mental health, etc
SCF Suboxone Program Clinic stage Pre-induction Done by Psychiatrist, Suboxone Case manager Customer education Regarding opiate withdrawal Regarding use of Buprenorphine Regarding induction appointment Customer contract Lost/stolen RX s, early refills, pill counts, toxicology screens, diversion, etc Set up plan for WIthdrawaland induction appt.
SCF Suboxone Program Clinic Phase - Induction Establish in moderate severe opiate withdrawal Provide Buprenorphine dose Re-eval withdrawal symptoms ~Q hour and repeat Buprenorphine challenge until withdrawal complete Monitor for Precipitated withdrawal
SCF Suboxone Program Clinic Phase - Stabilization Done by Psychiatrist, substance abuse, clinic staff Monitor for Medication compliance Monitor for psychosocial treatment compliance (E.g. DAC, SuBoxone group, etc) Monitor for illicit substance abuse/diversion Pill counts, urine tox, urine Buprenorphine screens Monitor for abstinance symptoms Monitor medication Side effects Monitor psychosocial functional improvement Determine when sufficiently stable to refer back to primary care
Treatment Program 2X/week suboxone group. PRN meetings with Bonnie Hughes (case manager, exemplar) Community Support groups (mandatory) Establishment of community sober support system (mandatory) Pill Counts Tox and Buprenorphine Screens On going evaluation of THC, etoh use
Treatment Program Ongoing assessment of functionality and well being Integration of Mental Health Counseling Integration of psychiatric treatment On going dialogue regarding treatment response and limitations
Clinical Use of Buprenorphine Detoxification Determination made by customer unless breaks agreement > 90% relapse after taper Consider Naltrexone/Vivitrol