Arwen Podesta, MD. ABIHM, ABAM, Forensic Psychiatry

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The State of Medicine in Addiction Recovery Arwen Podesta, MD ABIHM, ABAM, Forensic Psychiatry www.podestawellness.com 504-252-0026

http://www.addictionpolicy.org/

Overview Addiction is a serious, chronic and relapsing disorder, use multiple evidence based treatments Medications should be considered as part of a comprehensive treatment plan, addressing both disordered physiology and disrupted lives Medications should be considered for treatment of: psychiatric sx s, addictive d/o s, and co-occurring d/o s Emerging literature supports use of meds in youth with SUDs and psychiatric comorbidity

Addiction is a brain disease

ASAM Short Definition of Addiction A Primary, chronic, RELAPSING disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursing reward and/or relief by substance use and other behaviors. -ASAM

Does Abstinence-Based Treatment Work? National Treatment Outcome Research Data on Opioid Addiction Patients 242 patients in residential treatment: 34% relapse w/in 3 days 45% relapse w/in 7 days 50% relapse w/in 14 days 60% relapse w/in 90 days Multiple Studies consistently show 2/3 of patients in abstinencebased programs relapse. Dr Batki, MD Prof of Psy, Upstate Med Center Syracuse

Does Abstinence-Based Treatment Work? Studies: Of patients who complete abstinence-based treatment only 36% are sober at one year. Why? Multiple reasons Hypodopaminergic brain, Post-Acute Withdrawal discomfort, Denial, Minimization, Lack of Support, Co-occurring Illness, No meetings, No sponsor, no Monitoring, Not followed medically like other chronic illnesses.

Why do people relapse?

39% wanted to try opioid drugs once more 62% mood was bad 48% ease of access to opioids Reasons for Relapse 62% cravings were too much 37% 43% someone offered them opioids missed the support of the treatment center References: 1. Ducray K, Darker C, Smyth BP. Situational and psycho-social factors associated with relapse following residential detoxification in a population of Irish opioid dependent patients. Ir J Psych Med. 2012;29(2):72-79. 2. National Institute on Drug Abuse. Principles of Drug Addiction Treatment: A Research-Based Guide. 2nd ed. Bethesda, MD: National Institute on Drug Abuse, National Institutes of Health; 2009. NIH publication 09-4180. 9

Success rates vary Depending on The Individual The Addiction Co Morbid conditions Psychosocial/Family

Podesta A. HOOKED: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers. Indianapolis, IN: Dog Ear Publishing; 2016.

Relapsing Disease Medical relapse Blame the medication or the disease Aggressive work up to find treatments to protect patient from the disease Addiction relapse Blame the patient

Medication Assisted Treatment/Recovery Use sparingly and only when needed Treat symptoms to help patient stay in recovery and learn tools for long term wellness Some meds may be long term, but most will be short term while neurogenesis and synaptogeneiss and neural repair occur, especially in the first 3-6 months of recovery. My whole philosophy is stabilizing until the foundation is built, then moving away from medications when possible.

Medication Assisted Treatment/Recovery Podesta A. HOOKED: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers. Indianapolis, IN: Dog Ear Publishing; 2016.

Medication Assisted Treatment/Recovery: Alcohol FDA-Approved: Disulfuram (Antabuse) PO naltrexone (Revia) IM naltrexone (Vivitrol) Acamprosate (Campral) Non-FDA-approved: Topiramate (Topamax) Ondansetron (Zofran) Baclofen Dependence

Medication Assisted Treatment/Recovery: Opioid Dependence Detoxification: Opioid-based agonist (methadone, buprenorphine) Non-opioid based (clonidine, supportive meds) Antagonist-based (naltrexone: rapid ) Relapse prevention: Agonist maintenance (methadone) Partial agonist maintenance (buprenorphine) Antagonist maintenance (naltrexone) Overdose reversal: Naloxone (Narcan nasal, Auto-injector)

Medication Assisted Treatment/Recovery: Opiate Receptor Activation

Medication Assisted Treatment/Recovery: Opioid Substitution Goals Reduce symptoms & signs of withdrawal Reduce or eliminate craving Block effects of illicit opioids Restore normal physiology Promote psychosocial rehabilitation and non-drug lifestyle

Maintenance Medication- Reduce Relapse Rates 40 Heroin Addicts randomized to: 1 week detox followed by placebo and counseling 1 year BUP maintenance and counseling Heroin use Buprenorphine detox, placebo maintenance = 100% relapsed - 4/20 died!! Buprenorphine maintenance = 75% (SD 60%) opioid negative urine drug screens. 0/20 deaths

Maintenance Medication- Reduce Relapse Rates

Medication Assisted Treatment/Recovery: Buprenorphine Suboxone, Subutex, Zubsolv, Bunavail FDA approved 2002, age 16+ Mandatory certification from DEA (100 pt. limit) Office-based, expands availability Analgesic properties Ceiling effect Mechanism: μ- opioid PARTIAL agonist

Studies of MAT with Suboxone How long should it be used? MAT with Suboxone for 7 days vs 28 days in 990 pts with Opioid SUD Similar relapse rates either way - about 87% at three months (Ling 2009) MAT with Suboxone for 3 mo 60% opioid free at 1 year (Katz 2009/Galanter 2003) MAT with Suboxone for 6 9 mo 90% opioid free after one year (did not look at other drugs) (Badgaiyan 2015)

Naltrexone/Vivitrol For opioids and alcohol dependence Daily oral or 1x monthly injectable Covered by Medicaid/Medicare (LA)

Cost effectiveness of treatment Cost to society of drug abuse is $200 BILLION/year Treatment is less expensive than incarceration Methadone Maintenance = $4700/year Imprisonment = $18400/year Other studies show that every $1 invested in treatment can yield up to $7 in savings

VIVITROL IN OPIOID DEPENDENCE: PRIMARY STUDY ENDPOINT Patients treated with VIVITROL and counseling had a SIGNIFICANTLY HIGHER PERCENTAGE OF OPIOID- FREE WEEKS 124 PLACEBO 126 VIVITROL During weeks 5 24 35% PLACEBO Median placebo patients (with psychosocial support) had 35% cumulative opioid-free weeks P=0.0002 Confirmed abstinence = negative urine drug test and no self-reported opioid use 90% VIVITROL Median VIVITROL patients (with psychosocial support) had 90% cumulative opioid-free weeks Reference: 1. Krupitsky E et al. Lancet. 2011;377(9776):1506 1513. Please see Important Safety Information throughout this presentation. Prescribing Information and Medication Guide will be furnished during this program. 38

VIVITROL IN ALCOHOL DEPENDENCE: PRIMARY STUDY ENDPOINT In the prespecified subset (n=53, 8% of the total study population) patients who abstained for 7 days prior to the first injection had 92% FEWER HEAVY-DRINKING DAYS Median heavy-drinking days per month The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation Baseline for both VIVITROL 380 mg and placebo was 15.2 heavy-drinking days per month 2.5 Days PLACEBO 0.2 Days VIVITROL 380mg Week 24 Week 24 P=0.005 18 PLACEBO 17 VIVITROL Placebo (with psychosocial support) median heavydrinking days per month VIVITROL 380 mg (with psychosocial support) median heavy-drinking days per month 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 References: 1. Garbutt JC et al. JAMA. 2005;293(13):1617 1625. 2. Data on file. Alkermes, Inc. 3. VIVITROL (naltrexone for extended-release injectable suspension) [prescribing information] Waltham, MA: Alkermes, 2015. Please see Important Safety Information throughout this presentation. Prescribing Information and Medication Guide will be furnished during this program. 45

Current Opioid MAT Controversies Which patients should be offered MAT and when in their treatment course should they be offered it? How long do you continue MAT? How to change someone from Methadone or Buprenorphine to Vivitrol? Long-term side effects of all? MAT vs Abstinence and is there a happy medium? Is a patient who uses medication to maintain sobriety in real recovery (and does it matter)????lawsuits alleging failure to meet the standard of care/ best practices???

Naloxone Expanded Access is Recommended Many organizations strongly recommend that naloxone be readily accessible to individuals likely to witness a lifethreatening opioid emergency World, Federal, State, Medical Organizations Arwen Podesta MD www.podestapsychiatry.com

Available Naloxone Formulations Naloxone for Medical Settings Vial and syringe for Injection Prefilled Glass Cartridges for Injection Take-Home Naloxone Naloxone Auto-injector Naloxone Nasal Spray Other Naloxone Option Intranasal (IN) Delivery Kit - Prefilled Cartridge for Injection adapted for IN Administration with Mucosal Atomizer Arwen Podesta MD www.podestapsychiatry.com

The State of Medicine in Addiction Recovery Arwen Podesta, MD ABIHM, ABAM, Forensic Psychiatry www.podestawellness.com 504-252-0026