NYSAM 2011 Case Presentation Edwin A. Salsitz, M.D. FASAM Beth Israel Medical Center New York City

Physician Clinical Support System PCSS… answers questions about opioids, including methadone, for treatment of chronic pain answers questions about use of buprenorphine for treatment of opioid dependence

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ADDICTION/PAIN TREATMENT “All Treatments Work For Some People/Patients” “No One Treatment Works for All People/Patients” Alan I. Leshner, Ph.D Former Director NIDA

CT 2010 Case Presentation 54 y.o. ♀ evaluated on 6/19/09 Headaches major medical problem ? Paternal uncle—EtOH Lives with husband, has 2 adult stepchildren Upper level executive in marketing, 250K Through H.S. no drugs or EtOH

CT 2010 Case Boyfriend 1st year of college introduced to heroin IN 1st use may have led to gang rape? Uncontrollable crying over story 1st “migraine” around this time, frequent & severe “nervous breakdown” after boyfriend ends relationship in 2nd year college Heroin INIV x 2yrsillicit methadoneTC Abstinent age 25

CT 2010 Case Migraines lessened in 30’s and 40’s  frequency and severity post-menopause Opioids X 4 years—oxyCR & oxyIR Nationally known HA clinic—weaned off opioids 2 yrs ago—severe HAsopioids(1 mo.) Neuro and Pain Specialist—ran out of meds 1 week early? Inpatient “detox”--?work Current meds. Oxy CR 30mg tid OxyIR 5mg qid(NSAID, ondansetron, prednisone, venlafaxine, topiramate)

CT 2010 Case Age 17—appendectomy—1st opioid— “felt good,” “took away my insecurities” Subsequent heroin--- “energized” Sobbing and Crying at mention of mother who died 9 mos ago at age 93 Felt she was a terrible disappointment to mother Saw therapist on and off for many years—currently not in psychotherapy

Diagnosis and Plan After Initial Consultation Opioid Physical Dependence Pain Paradigm Husband to Dispense Opioids Attempt to taper opioids Rx Oxy CR 30mg—attempt bid One week later 1.Oxy CR bid 2. D/C venlafaxine, start duloxetine 3. Oxy IR 5 q6h prn

3 Weeks later Headaches have markedly increased while on vacation—husband not in agreement on chronic opioid paradigm Neurologist adds gabapentin 300mg tid and topiramate(now 100mg.qd) Continued attempts to taper opioids not successful

4 Weeks Later Husband no longer coming in with patient Headaches daily—making work and home difficult After long discussion, OXY CR d/c’d and methadone low dose started and titrated upwards

After 7 months Stable methadone dose 30mg tid Infrequent short acting opioids Significant improvement in headache frequency, severity, Improved function at work Stopped therapy, and refuses new therapy Marital issues difficult to discuss All urines, pill counts, appts., etc reveal no problematic behavior Overall patient rating 93(as of 4/13/10)

April 2010Present June 2010—2 Rxs given for methadone October 2010---Short Acting Opioids D/C’d October 2010---Methadone  30mg bid Headaches present, but  intensity/frequency Stigma issue around methadone continues Marital issue, no psychosocial Random urines negative

41(59%) Responders by 50% in SHI—freq x duration severe headache/week NEUROLOGY 2004;62:1687-1694 160 enrolled 70 remained on daily scheduled opioids X 4 yrs 74% LA, 26% SA 41(59%) Responders by 50% in SHI—freq x duration severe headache/week

Figure 1. Medical record versus visual analog scale: mean percentage improvement in year 3 or 4 of daily scheduled opioids (year 4 for patients in program for 4 years or more)‏ Saper, J. R. et al. Neurology 2004;62:1687-1694

Dose Violation most common Most problems not “severe” Figure 2. Problem drug-related behavior: patients with any incident of problem opioid behavior over 4 years of daily scheduled opioids Saper, J. R. et al. Neurology 2004;62:1687-1694 Dose Violation most common Most problems not “severe”

OPIOIDS ? Endorphin Deficiency U B E T Chronic Pain Addiction Somatic Sxs Hedonic Tone OPIOIDS ? Endorphin Deficiency Anti-Depressants Anti-Convulsants Mood Stabilizers Pain Medicine Prescriptions Pharmacies Legitimate Addiction Treatment Methadone Clinics Regulations Stigma Buprenorphine

*Anterior Cingulate Gyrus

MesoLimbic Dopaminergic Circuit Pleasure/Reward Center Acc VTA Amphetamine Cocaine Opiates Cannabinoids Phencyclidine Ketamine HIPP GLU FCX AMYG CRF GLU 5HT GABA OPIOID OPIOID ENK GABA GABA VP DYN 5HT OFT DA BNST GABA NE ABN LC Opiates PAG NE HYPOTHAL END LAT-TEG To dorsal horn Opiates Ethanol Barbiturates Benzodiazepines Nicotine Cannabinoids 5HT ICSS Raphé MesoLimbic Dopaminergic Circuit Pleasure/Reward Center H2O, Food, Sex, Parenting, Socializing RETIC

HCC=Healthcare for Communities 1998, 2001

Association of common mental disorders in 1998 with regular prescription opioid use in 2001: unadjusted odds ratios with 95% confidence intervals Sullivan, M. D. et al. Arch Intern Med 2006;166:2087-2093. Non-Cancer Pain Copyright restrictions may apply.

Journal of Addictive Diseases, Vol.27(3) 2008

Journal of Addictive Diseases, Vol.27(3) 2008

Problematic (Aberrant) Behaviors Probably more predictive Selling prescription drugs Prescription forgery Stealing or borrowing another patient’s drugs Injecting oral formulation Obtaining prescription drugs from non-medical sources Concurrent abuse of related illicit drugs Multiple unsanctioned dose escalations Recurrent prescription losses Probably less predictive Aggressive complaining about need for higher doses Drug hoarding during periods of reduced symptoms Requesting specific drugs Acquisition of similar drugs from other medical sources Unsanctioned dose escalation 1-2 times Unapproved use of the drug to treat another symptom Reporting psychic effects not intended by the clinician Passik and Portenoy, 1998

The ORT Form-Opioid Risk Tool Mark each box that applies 1. Family history of substance abuse Female Male Alcohol [ ] [ ] Illegal drugs [ ] [ ] Prescription drugs [ ] [ ] 2. Personal history of substance abuse Alcohol [ ] [ ] 3. Age (mark box if 16-45) [ ] [ ] 4. History of preadolescent sexual abuse [ ] [ ] 5. Psychological disease Attention deficit disorder, obsessive- compulsive disorder, bipolar, schizophrenia [ ] [ ] Depression [ ] [ ] 1 2 4 3 5 Patients are asked to identify their age; history of preadolescent sexual abuse; family and personal history of substance abuse, including alcohol, illegal drug, or prescription drug abuse; and psychological diseases such as attention deficit disorder, obsessive-compulsive disorder, bipolar disorder, schizophrenia, or depression. The probability of opioid abuse increases with the number of positive responses. Responses to each question are weighted differently based on gender and risk factor. Each risk factor is assigned a point value comparative to other risk factors. Courtesy of Lynn Webster, M.D.

Validation Study Results Total score risk category   Low risk: 0–3   Moderate risk: 4–7   High risk: ≥ 8 Validation Study Results ORT Total Score Risk Category 100 90.9 80 60 Aberrant Behavior Displayed (%) 40 28 The validation study of the ORT showed a strong relationship of the link between the total score risk category and observed aberrant behavior. For those patients in the low risk category, “unlikely to abuse opioids”, only 5.6% displayed an aberrant behavior. For those patients in the moderate risk category, “as likely to abuse opioids as not to abuse opioids”, 28% displayed aberrant behaviors. For those patients in the high risk category, “likely to abuse opioids”, 90.9% displayed aberrant behavior. The ORT displayed excellent discrimination for both sensitivity and specificity and provided gender-specific positive predictive values for high risk patients of 87% to over 95%. 20 5.6 Low Moderate High Webster LR and Webster RM. Predicting aberrant behaviors in opioid-treated patients: validation of the Opioid Risk Tool. Pain Med. 2005;6:432-442. Non-Cancer Pain

Russell Portenoy, M.D.

“…as we know, there are known knowns, there are things we know we know “…as we know, there are known knowns, there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns – the ones we don’t know we don’t know.” – Donald Rumsfeld

“MORPHINE IS GOD’S OWN MEDICINE” Sir William Osler

ADDICTION/PAIN TREATMENT “All Treatments Work For Some People/Patients” “No One Treatment Works for All People/Patients” Alan I. Leshner, Ph.D Former Director NIDA

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