Opioid Replacement Therapy (ORT): Yes or No?

Transcription

1 Opioid Replacement Therapy (ORT): Yes or No? Carl Christensen, MD, PhD, FASAM Associate Professor, Dept OB Gyn, WSU (retd) Medical Director, Addiction Medicine Services, DMC Past Chair, Michigan Health Professional Recovery Program Past President, Michigan Society of Addiction Medicine Disclaimers Consultant, PCSS Consultant, DEA/FBI/ DOJ Consultant, BCBS Speaker, Reckitt Benckiser Former: Methadone provider, WSU Medical Director, Dawn Farm What is Addiction? What is Addiction? Addiction is not a withdrawal problem. Addiction is not a withdrawal problem. Addiction is: Craving Compulsive use Loss of CONTROL once you start Use despite CONSEQUENCES 9 10 What causes Addiction? Physiologic Dependence: Tolerance and Withdrawal Physiologic Dependence? Lack of willpower? An amoral condition? A brain disease? Tolerance: requiring increasing amounts of drug to get the same effect Withdrawal: the opposite effect of the drug when it is removed NEITHER of these imply chemical dependency (addiction)

2 Physiologic Dependence: Tolerance and Withdrawal Drug WITHDRAWAL: Gardner people are treated with morphine for two weeks after an accident. Their insurance runs out, the morphine is suddenly stopped. 95 of them will have the flu (physical withdrawal) and will go on with their lives. 5 of them will start robbing party stores to get more morphine!!!! = ADDICTION Drug ADDICTION: Gardner 2006 Lack of Willpower? An amoral condition? Brain disease?

3 Nucleus Accumbens = the Pleasure Center The Nucleus Accumbens: GO!!! Responds to dopamine (DA) Part of the LIZARD BRAIN Responds to drugs Responds to food Responds to sex Sends signals to your frontal cortex THE PLEASURE CENTER IS ABNORMAL (DAMAGED) IN ADDICTION VTA: the gas tank : supplies dopamine to the Nucleus Accumbens Frontal Cortex: STOP!!!! Which came first? Do some people develop addiction because they have reward deficiency syndrome (decreased dopamine) OR: Do people with addiction have low dopamine because they have burned out their pleasure centers?

4 Abnormal response to Ritalin (methylphenidate) is due to abnormal brain chemistry Predisposed to addiction? Those who enjoyed methylphenidate (amphetamine) had LOWER levels of dopamine. Those who found it unpleasant had NORMAL levels of dopamine Conclusion? - addiction is an abnormal response to reward I feel like I don t belong in my own skin. anonymous alcoholic Decreased Dopamine receptors =decreased Dopamine = Decreased Hedonic Tone Salsitz 2006 Can you find the (alleged) future alcoholic? Grand Rounds Hutzel Why Can t They Stop????? Alcoholics/addicts who finish treatment will often relapse when they re-enter society. Stimulants & Blood Flow High They will almost ALWAYS relapse if they undergo quick detox and re-enter society. But: their withdrawal is gone. SO: why do they relapse????? Healthy Control Gottschalk, 2001, Am J Psychiatry Cocaine-dependent Low

5 Blood Flow Recovery Non users High Blood Flow Recovery Non users High Cocaine users, 10 days sober Cocaine users, 10 days sober Cocaine Users, 100 days sober Low Cocaine Users, 100 days sober Low Blood Flow Recovery Non users High Blood Flow Recovery Non users High Cocaine users, 10 days sober Cocaine users, 10 days sober Cocaine Users, 100 days sober Low Cocaine Users, 100 days sober Low [C-11]d-threo-methylphenidate RELAPSE: the problem with addiction HOW LONG to recover from Methamphetamine???? Normal Control Methamphetamine Abuser (1 month abstinent) high low Drug triggered: I thought I could (eat/smoke/drink) just one. Stress triggered: I m going through too much right now. Gimme that! Methamphetamine Abuser (14 months abstinent) Cue triggered: Wet faces and wet places 69 Volkow et al., J. Neuroscience,

6 Stress Triggered Relapse: Gardner 2006 RELAPSE: the problem with addiction Drug triggered: I thought I could (eat/smoke/drink) just one. Stress triggered: I m going through too much right now. Gimme that! Cue triggered: Wet faces and wet places Cue Triggered Relapse: Gardner 2006 How Do You Treat Addiction? Voluntary/Forced Abstinence Counseling (CBT) Mutual Help Groups (AA/ NA) Motivational Enhancement OP/IOP/Residential Treatment Medication Assisted Therapy How Do You Treat Addiction? Medication Assisted Therapy: opiates Agonists Methadone Buprenorphine +/- Naloxone Antagonists (NOT FOR PREGNANCY) Naltrexone Rivea (tablets) Vivitrol (injections) Benefits of MMT Salsitz, ASAM, 2012 Reduction in death rates (Grondblah, 1990) Reduction in IVDU (Ball & Ross, 1991) Reduction in # of crime days (Ball & Ross) Reduced HIV seroconversion / HCV conversion Reduction to relapse to IVDU (Ball & Ross) IMPROVED OUTCOME AFTER INCARCERATION 74 6

7 CAREFUL! Ball 1988: reduction in IVDU 78 CAREFUL! Ball 1988: resumption of IVDU! The major risk of methadone is respiratory depression. It makes relapse SAFER Benzodiazepine use makes it MORE DANGEROUS Benzodiazepines should NOT be combined with methadone! 83 Methadone for Addiction: Cochrane database Drug related deaths CDC, July 2012 Buprenorphine is an effective treatment for heroin use in a maintenance therapy approach compared with placebo. However, methadone maintenance treatment at high dose is associated with higher rates of retention in treatment and better suppression of heroin than buprenorphine maintenance treatment. Methadone, however, has been found to be associated with more frequent overdose and death (4.8 vs 0.9/1000 patient-years) (Bell, 2009) 7

8 Methadone deaths: due to CLINCS or PILLS? Policies at the Jefferson Clinic WSU Psychiatry Dept Patients who are positive for benzodiazepines are referred for residential treatment** To have a prescription for benzodiazepines, they must be seeing a psychiatrist who is aware they are going to a methadone clinic. Patients may obtain pain meds from only ONE physician who is aware they are attending a methadone clinic. NO schedule 2 opioids allowed (morphine, Oxycontin, fentanyl) Policies at the Jefferson Clinic Buprenorphine ( Suboxone ) Patients must have a negative urine within 12 weeks, 2 in the second 12 weeks, etc. Relapses are addressed immediately with loss of take homes, increased group attendance, etc. Patients are referred to residential treatment for failure of methadone treatment. A partial opiate agonist Less analgesic effect Less respiratory depression <100 documented deaths in the U.S. (Soyka); PER YEAR WITH METHADONE Treats both pain and opiate dependency Different formulations are approved 91 Agonist, partial agonist, antagonist. Approved for DEPENDENCY Subutex :* sublingual buprenorphine; Approved for PAIN Burpenex : injectable generic ONLY now!; PREFERRED IN PREGNANCY Suboxone : sublingual buprenorphine + naloxone (Narcan ): prevents IV use. NALOXONE DOES NOT CAUSE WITHDRAWAL Now as FILM STRIP Buprenorphine Butrans: transdermal, low dose patch. 93 8

9 Buprenorphine long-term follow up: Fiellin, 2008 Buprenorphine long-term follow up: Fiellin, 2008 Of those who remained in treatment: 91% were negative for opioids 96% were negative for cocaine! Satisfaction score: 86% Treatment Improvement Protocol (TIP)#40: SAMHSA What about pregnancy? Methadone is currently the standard of care in the United States for the treatment of heroin addiction in pregnant women. If such specialized services are refused by a patient or are unavailable in the community, maintenance treatment with the buprenorphine monotherapy formulation may be considered as an alternative. 106 MOTHER STUDY Methadone vs. Buprenorphine: the MOTHER study 107 Measure Methadone Buprenorphine Amount of MS required # of days in hospital Duration of treatment for NAS Birthweight % preterm delivery 19 7* Positive drug screen at delivery 15% 9%* Dropped out 18%

10 Vivitrol (naltrexone) for opioid dependence Vivitrol: abstinence Vivitrol: craving Doc, when can I get off this sh*t (medication)? Detoxing During Pregnancy? Luty 2003 Detoxing During Pregnancy? Luty women underwent detox during pregnancy 40 successfully detoxed. No adverse fetal effects documented 101 women underwent detox during pregnancy 40 successfully detoxed. No adverse fetal effects documented But: only 1/101 patients documented to be abstinent at time of delivery! Luty et al, J Sub Abuse Treat 24 (2003); Luty et al, J Sub Abuse Treat 24 (2003);

11 Maintenance vs. Detox? 40 heroin addicts were started on Suboxone. 20 were detoxed off and offered counseling. 20 were kept on Suboxone and offered counseling. A year later. 118 Subo xone lectur e Conclusions Medication Assisted Treatment is effective. Stopping MAT will usually result in relapse & increased chance of death. Why would you expect otherwise? Buprenorphine and Methadone have similar efficacy. Buprenorphine has a better safety profile. Methadone is more effective at higher doses (?heroin?) Vivitrol (injectable naltrexone) is effective at reducing opioid use. 119 Subo xone lectur e Why do people relapse after release from prison? Lack of housing Lack of employment Financial problems Exposure to drugs Exposure to wet faces and wet places THE UNDERLYING DISEASE OF ADDICTION Hartfree, 2007 Berrien County: 1 clinic Genesee County: 1 clinic Ingham county: 4 clinics Isabella county 1 clinic Jackson County 1 clinic Kalamazoo county 1 clinic Kent county 2 clinics Muskegon County 1 clinic Methadone clinics in Michigan Macomb County 3 clinics Monroe County 1 clinic Oakland County 3 clinics Washtenaw County 1 clinic Wayne County 13 clinics 11

12 Michigan Clinics in Michigan 21 of the 34 methadone clinics are in southeastern Michigan 12 clinics are responsible for over 50,000 square miles of Michigan Many counties have no resource for methadone maintenance Problems with methadone Requires initial daily dosing Must be clean for 2 years before you can dose monthly! Methadone clinics may be a source of wet faces and wet places (people still using drugs) Employers will frequently test for methadone and not employ methadone users, even if they are negative for other drugs. Questions: Does medication assistance improve outcomes after release from prison? Can buprenorphine be used for medication assistance after release from prison, rather than methadone? Does medication improve outcomes in released prisoners? Australia Prisoners who were placed in methadone programs less likely to die than prisoners released without methadone: 17 PRISONERS DIED WITHOUT METHADONE, NONE DIED ON METHADONE Less likely to be re-incarcerated Less likely to be infected with hepatitis C However, less than 1/3 remained on methadone after release. This indicates the need for improved follow up after release and a more acceptable program. Does medication improve outcomes in released prisoners? Riker s Island Prisoners in the Riker s Island KEEP program were less likely to commit crimes and use drugs if they were enrolled in methadone programs before their release. Their likelihood of remaining in methadone programs, however was low, showing a need for improved services. Does medication improve outcomes in released prisoners? Baltimore Prisoners with a history of heroin addiction received counseling prior to release Some also received methadone, either BEFORE they were released or immediately after they were released. TWO OF THE 70 INMATES WHO RECEIVED COUNSELING ONLY DIED. THERE WERE NO DEATHS IN THE METHADONE GROUPS. Only half the prisoners who received ONLY counseling stayed with their treatment 12

13 Does Suboxone work for Release Programs? The Riker s Island Study Rikers Island s program = Key Extended Entry Program (KEEP) provides methadone to opioid addicts while in jail and referral to treatment once released. A study done at Rikers Island randomized inmates enrolled in KEEP to Suboxone (60) or methadone (56) After starting their medication, they completed jail sentences and were released. Inmates were asked if they planned to continue treatment Does Suboxone work for Release Programs? The Riker s Island Study Inmates who started Suboxone were: MORE likely to plan to continue treatment when they were released (93 vs. 44%) MORE likely to show up for treatment after release from jail (48 vs. 14%) MORE likely to continue to take their medication after release (48 vs. 23%) The incidence of drug use, re-arrest and re-incarceration were the same. Inmates were followed up after release from jail; monitored for re-arrest and re-incarceration. Does Suboxone work for Release Programs? The Puerto Rico Study 45 inmates were started on Suboxone before their release from jail 3 dropped out, 3 were lost to follow up WHY BOTHER TO TREAT ADDICTION? One month after discharge, 78% were still using suboxone This is as good as treatment in non-incarcerated clients 75% had negative urines There were large decreases in drug use & crime days for those completing treatment 176 Why Treat Addiction? Drug Dependence, a Chronic Medical Illness: McLellan 2000 Only about 40% of patients will be abstinent at one year after treatment. Failure rates may be due to lack of aftercare, often due to insurance difficulties Low economic status, psych comorbidity and lack of family/social supports also predict relapse. Relapse is often viewed as inevitable and drug dependence as hopeless *

14 Drug Dependence, a Chronic Medical Illness: McLellan 2000 ONLY 60% OF TYPE I DIABETICS ADHERE TO MEDICATION SCHEDULE LESS THAN 40% OF ASTHMATICS ADHERE TO TREATMENT REGIMEN LESS THAN 40% OF HYPERTENSIVES ADHERE TO THEIR TREATMENT REGIMEN DRUG DEPENDENCE =40 TO 60% ADHERENCE Addiction: a chronic illness If you were to stop taking your insulin, and you wound up in a coma in the ICU, your doctor would say: you need to go back on insulin! You could have died! If you were to stop your Suboxone/methadone/12 step treatment, and wind up in the ICU, your doctor would say: You re an addict. You re hopeless!!!!! Obesity Chronic, Treatable but Incurable Diseases Hypertension Diabetes Asthma Addiction Contact info: Carl Christensen ccmdphd@mac.com Voice mail: Fax: Painrecoverysolutions.com