Treatment for Veterans with Opioid Use Disorders

Treatment for Veterans with Opioid Use Disorders

Medications for Treatment of Substance Use Disorders (SUDs) David Willey MD Substance Use Unit Director Cottonwood Springs Hospital VETERANS HEALTH ADMINISTRATION Original Presentation and multiple slides courtesy of: Karen Drexler, MD Deputy National Mental Health Program Director- Addictive Disorders Office of Patient Care Services 1 Department of Veterans Affairs M

fo Learning objectives The participant will be able to: Understand the rationale for using medications to treat substance use disorders Understand the risks and benefits of different medications for treatment of withdrawal from: Alcohol Opioids Understand the risks and benefits of different medications for treatment of: Alcohol use disorder Opioid use disorder

Reversal of opioid overdose Tobacco use disorder VETERANS HEALTH ADMINISTRATION Overview Why medications? Withdrawal management: Alcohol Opioids Relapse prevention: Alcohol Opioids Tobacco VETERANS HEALTH ADMINISTRATION

Why Medications? SUDs are chronic brain diseases Multifactorial, like other chronic diseases Respond best to comprehensive treatment Require long-term treatment Medications improve treatment outcome over psychosocial interventions alone Prevent medical complications of alcohol and opioid withdrawal Facilitate engagement in psychosocial treatment Reduce craving and risk of relapse Protect against opioid overdose VETERANS HEALTH ADMINISTRATION Substance Use Disorders are Chronic Brain Diseases

Known pathophysiology Treatment response similar to other chronic diseases Respond best to a combination of psychosocial interventions and medications (when available). VETERANS HEALTH ADMINISTRATION 5 Interconnected Networks Mediating Motivation and Decision-making George Koob, PhD (2013)

VETERANS HEALTH ADMINISTRATION Compliance and Relapse in Chronic Medical Disorders Insulin-dependent diabetes Compliance with medication Compliance with diet and foot care Retreated within 12 months <50% <30% 30 50% Medication-dependent hypertension Compliance with medication <30% Compliance with diet <30% Retreated within 12 months 50 60% Substance use disorders Compliance with treatment attendance <40% Retreated within 12 months 10 40% VETERANS HEALTH ADMINISTRATION OBrien CP, McLellan AT. Lancet. 1996;347:237-240. Overview Why medications? Withdrawal management: Alcohol Opioids Relapse prevention: Alcohol (Cocaine) Opioids Tobacco VETERANS HEALTH ADMINISTRATION

Mild-to-Moderate Alcohol Withdrawal Time course Begins 6 to 8 hours after last drink Peaks at 24 to 48 hours after last drink Symptoms may include some or all of the following: Anxiety and/or irritability Insomnia Tremor Headache Gastrointestinal disturbance Perceptual disturbances

Diaphoresis Hypertension Increased heart rate VETERANS HEALTH ADMINISTRATION Myrick H, Anton R. CNS Spectrums. 2000;5:22-32. Severe Alcohol Withdrawal Alcohol withdrawal seizures Usually occur 6 to 48 hours from last drink Delirium tremens Gradual onset 2 to 3 days from last drink, peaks at 4 to 5 days

Includes altered mental status and some or all of the following: Disorientation Perceptual disturbances and/or hallucinations Fluctuating mental status Tremor Diaphoresis Hypertension Increased heart rate Fever Gastrointestinal disturbance VETERANS HEALTH ADMINISTRATION Myrick H, Anton R. CNS Spectrums. 2000;5:22-32.

Alcohol Withdrawal Treatment Assess withdrawal risk using standardized scale (e.g. CIWA-Ar, AUDIT-PC, etc.) Based on and using shared decision-making, determine treatment setting- acute inpatient or ouwithdrawal risk tpatient Stabilize with medication (e.g. benzodiazepine, anticonvulsant)

Gradually withdraw medication (e.g. reduce 20% daily over 5 days) Supplemental vitamins and minerals Thiamine Folic acid Multivitamin Supportive treatment Decrease stimulation, increase fluid and caloric intake VETERANS HEALTH ADMINISTRATION

Myrick H, Anton R. CNS Spectrums. 2000;5:22-32. Inpatient Medically Managed Withdrawal Recommended for patients with: History of delirium tremens or withdrawal seizures Inability to tolerate oral medication

Co-occurring medical conditions that would pose serious risk for ambulatory withdrawal management (e.g., severe coronary artery disease, congestive heart failure, liver cirrhosis) Severe alcohol withdrawal (i.e., Clinical Institute Withdrawal Assessment for Alcohol [revised version] [CIWA-Ar] score >/ = 20) Risk of withdrawal from other substances in addition to alcohol (e.g., sedative hypnotics) VETERANS HEALTH ADMINISTRATION Suggested for patients with at least moderate alcohol withdrawal (CIWA >/= 10) and:

Recurrent unsuccessful attempts at ambulatory withdrawal management Reasonable likelihood that the patient will not complete ambulatory withdrawal management (e.g., due to homelessness) Active psychosis or severe cognitive impairment Medical conditions that could make ambulatory withdrawal management problematic (e.g., pregnancy, nephrotic syndrome, cardiovascular disease, or lack of medical support system) 12 Alcohol Withdrawal

Medications Benzodiazepines (e.g. Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam, Oxazepam) Anticonvulsants (i.e. Carbamazepine, Gabapentin, Valproic Acid)

Efficacy in relieving mild to moderate alcohol withdrawal symptoms. Efficacy in preventing withdrawal seizures Potential for addiction and misuse May induce incoordination and increase risk of falls. VETERANS HEALTH ADMINISTRATION Efficacy in relieving mild to moderate alcohol withdrawal symptoms.

Insufficient evidence for preventing alcohol withdrawal seizures. Less potential for misuse Less potential for incoordination and falls. 13 Withdrawal Management: Opioids Withdrawal management alone is not recommended. Lack of evidence of efficacy for psychosocial intervention without medication. Risk of overdose (greatest in first few months after discharge from inpatient)

When opioid agonist maintenance treatment is not an option, Recommend withdrawal using opioid agonist medication: Buprenorphine Methadone- in an OTP or when patient is hospitalized for treatment of a medical condition other than narcotic addiction If opioid agonist medication is contraindicated, not preferred, or not available, recommend: Clonidine Plus adjunctive medications such as benzodiazepine, antiemetic, antidiarrheal, NSAIDs. VETERANS HEALTH ADMINISTRATION 14 Overview

Why medications? Withdrawal management: Alcohol Opioids Relapse prevention: Alcohol Opioids Tobacco Overdose reversal: Naloxone VETERANS HEALTH ADMINISTRATION Medications for SUDs Alcohol use disorder:

Acamprosate (Campral) Disulfiram (Antabuse) Naltrexone (Revia, Vivitrol) Topiramate (Topamax) Gabapentin (Neurontin) Opioid use disorder: Methadone Buprenorphine/naloxone (Suboxone, Subzolv, Bunavail) Naltrexone (Vivitrol)

Tobacco use disorder: Nicotine replacement (transdermal, gum, spray) Bupropion (Zyban, Wellbutrin) Varenicline (Chantix) Opioid overdose reversal Naloxone rescue kits and Evzio Naltrexone (ReVia, Vivitrol)

Mechanism of action: Mu opioid antagonist Craving reduction Decreased euphoria (may enhance extinction) Reduces risk of opioid overdose if slip occurs Usual dose: Oral - 50 to 100 mg once daily, Intramuscular - 380 mg/month Nota bene: Pretreatment abstinence from alcohol improves response (48 hours or more). Some patients experience dramatic craving reduction, some none. Adverse events:

Nausea, abdominal cramps, muscle aches Opioid withdrawal (in patients with recent opioid use) Renders opioid pain medications ineffective Injection site reactions for extended-release injectable naltrexone VETERANS HEALTH ADMINISTRATION Oral Naltrexone in the treatment of alcohol dependence Volpicelli et al: 1992 Arch Gen Psych 49(11):876-80 VETERANS HEALTH ADMINISTRATION Oral Naltrexone Reduces Relapse to Heavy Drinking

Source Duration in weeks Bias Risk Tx Group Event/ No event VETERANS HEALTH ADMINISTRATION Control Event/ No event

Risk Difference Favors treatment Favors control % weight 19 Oral Naltrexone Supports Abstinence from Alcohol

Source Duration in weeks Bias Risk Tx Group Event/ No event VETERANS HEALTH ADMINISTRATION Control Event/ No event

Risk Difference Favors tx Favors control Jonas et al: 2014, JAMA % weight 20 Oral Naltrexone

Injectable Naltrexone (Vivitrol) VETERANS HEALTH ADMINISTRATION 25 Extended Release Naltrexone Injection Associated with Reduced Mortality and Hospital Readmissions Outcome measure Odds Ratio for NTX-XR/control

1 year mortality 0.30 (p < 0.001) In subset with detox in prior year Subsequent 0.80 (p < 0.001) detox episodes 1 year mortality 0.78 (p < 0.001) Case-Control design 387 veterans with AUD received NTXXR 3759 controls Propensity score weighted, mixedeffects logistic regression model for 1-year mortality. For subset with at least one detox episode in previous year, # detox episodes in following year. Harris et al- 2015-Alcohol Clin Exp Res-39:7983 VETERANS HEALTH ADMINISTRATION

26 Naltrexone Precautions Contraindications Use of opioids Acute opioid withdrawal Anticipated need for opioid analgesics Acute hepatitis or liver failure Precautions Liver disease

Depression History of suicide attempts Injection site reactions Pregnancy Cat C VETERANS HEALTH ADMINISTRATION Drug interactions Opioid analgesics (blocks action) Thioridazine (increased somnolence)

Acamprosate (Campral) Mechanism of action: Modifies glutamate NMDA receptor function Reduces withdrawal relief craving Eliminated through the kidney Note: Alcohol abstinence at treatment initiation improves results. Usual dose: 333mg: 2 tablets 3 times daily Adverse events: Rare: suicidal ideation and behavior Common: diarrhea, sleepiness VETERANS HEALTH ADMINISTRATION Acamprosate (Campral) Acamprosate Supports

Abstinence in Alcohol Use Disorder VETERANS HEALTH ADMINISTRATION Jonas et. al 30 Acamprosate Precautions Contraindications Severe kidney disease (CrCl <30mL/min) Precautions

Moderate kidney disease Depression History of suicide attempts Pregnancy Cat C VETERANS HEALTH ADMINISTRATION Drug interactions None known Acamprosate vs. Naltrexone Maisel et al. (2012) meta-analysis examined when naltrexone & acamprosate are most helpful by testing relative efficacy & whether implementation strategies

moderate its effects. Findings support: Acamprosate larger effect size on abstinence maintenance Naltrexone larger effect size on reduction of heavy drinking & craving Detoxification before tx or a longer period of abstinence associated with larger medication effects for acamprosate VETERANS HEALTH ADMINISTRATION Pharmacotherapy for Adults With Alcohol Use Disorders in Outpatient Settings----A Systematic Review and Meta-analysis Most comprehensive, systematic review and meta-analysis of the comparative effectiveness of naltrexone and acamprosate across 135 studies concluded that:

Acamprosate and oral naltrexone have the best evidence for improving alcohol consumption outcomes for patients with alcohol use disorders. Head-to-head trials have not consistently established the superiority of one medication. Thus, other factors may guide medication choices, such as frequency of administration, potential adverse events, coexisting symptoms, and availability of treatments Evidence from well-controlled trials does not support efficacy of disulfiram, except possibly for patients with excellent adherence. Jonas et al. (2014) VETERANS HEALTH ADMINISTRATION Disulfiram (Antabuse)

Inhibits aldehyde dehydrogenase build-up of toxin (acetaldehyde) Active for up to 2 weeks. Usual dose: 250 mg once daily Adverse reactions: Common: Metallic or garlicky taste Drowsiness

Rash Serious: VETERANS HEALTH ADMINISTRATION Alcohol-disulfiram reaction Hepatitis

Neuropathy Psychosis Disulfram (Antabuse) Disulfiram Precautions Contraindications Recent alcohol use Cardiovascular disease Allergy to rubber (thiuram) derivatives Precautions

Liver disease Psychosis Epilepsy Hypothyroidism Diabetes mellitus Kidney disease Carry wallet card VETERANS HEALTH ADMINISTRATION Drug interactions Alcohol (cough syrups, mouthwash, wine sauce, etc.) Anticoagulants

(Coumadin) Isoniazid Metronidazole Phenytoin Opioid Use Disorder High mortality1 581 male admits to California Civil Addict Program (CAP) Average age at entry = 25 years 10-year mortality = 14% 20-year mortality = 28% 30-year mortality = 49%

Insufficient evidence that counseling alone is effective Medications: Opioid Agonist Therapy (OAT) is recommended as first-line: Methadone (in an OTP) Buprenorphine/naloxone If OAT is contraindicated, unavailable, unacceptable, or discontinued: Extended-release injectable naltrexone Insufficient evidence to recommend for or against oral naltrexone for OUD. VETERANS HEALTH ADMINISTRATION 1 Hser (2001) Arch Gen Psych 58:503-508 Methadone

Mu opioid agonist Usual dose: 60 - 120 mg once daily Efficacy: 1.72 (high dose vs low dose (<60 mg) Must be administered through Federally Regulated Opioid Treatment Program Methadone can be continued for patients hospitalized for treatment of a medical condition other than narcotic addiction (including alcohol use disorders). Adverse reactions: Common: Constipation Drowsiness Low testosterone Hyperalgesia VETERANS HEALTH ADMINISTRATION Serious: Cardiac arrhythmias Sudden cardiac death Methadone Precautions

Contraindications Allergy to methadone Precautions Drug interactions Respiratory, renal or liver impairment Prolonged QTc or arrhythmias Concurrent opioids (e.g. enrollment in another OTP) Partial opioid agonists

or antagonists Head injury Concurrent benzodiazepines, alcohol, or other CNS depressants CYP3A4 inhibitors may levelsketoconazole, erythromycin, HIV protease inhibitors VETERANS HEALTH ADMINISTRATION Buprenorphine (Suboxone)

Partial opioid agonist Usual dose: 4 - 24 mg once daily Efficacy: >8mg daily similar to methadone Adverse reactions: Common: Drowsiness

Constipation May precipitate opioid withdrawal VETERANS HEALTH ADMINISTRATION Serious: Cytolytic hepatitis Buprenorphine Precautions Contraindications Allergies to

buprenorphine or naloxone Precautions Drug interactions May precipitate opioid withdrawal Patients with liver, renal or respiratory impairment CNS depressionCaution in operating heavy machinery Head injury

Alcohol, benzodiazepines, and other CNS depressants CYP3A4 inhibitors may levelsketoconazole, erythromycin, HIV protease inhibitors VETERANS HEALTH ADMINISTRATION VETERANS HEALTH ADMINISTRATION 43 Short Buprenorphine Taper

versus Extended Buprenorphine Multisite randomized trial- 2-phase adaptive treatment research design 653 treatment-seeking outpatients dependent on prescription opioids Randomized to Standard Medical Management (SMM) or SMM plus counseling Phase 1: Two week stabilization, 2-week taper, 8-week post-medication follow-up Successful patients exited study; thoMethodsse who returned to opioid use entered Phase 2 Phase 2: Twelve week treatment, 4-week taper, 8-week post-medication follow-up Results: Phase 1: 43 of 653 (6.6%) had successful outcomes Phase 2:

177 of 360 (49%) achieved success at week 12, no group differences 31 of 360 (8.6%) maintained success 8 weeks post-medication Chronic pain did not affect outcome History of heroin use predicted poorer outcome during Phase 2 medication. VETERANS HEALTH ADMINISTRATION 44 VETERANS HEALTH ADMINISTRATION 46 Naltrexone (Revia/Vivitrol) Opioid antagonist with high affinity for mu-opioid receptors and lower affinity at kappa- and delta-opioid receptors

Effectively blocks the effects of heroin and other opioids Long half-life can be administered 3x week in doses of 100150 mg Generally well tolerated, side effects can include: GI distress, headaches, rare liver toxicity Poor adherence suggest use of injectable formulation Only given when acute withdrawal has been completed VETERANS HEALTH ADMINISTRATION 47 Improved Abstinence from Opioids and Reduced Craving with Extended-Release Naltrexone (XR-NTX) vs Placebo

VETERANS HEALTH ADMINISTRATION 2011-Krupitsky et al-Lancet- 377:1506 48 Overview Why medications? Withdrawal management: Alcohol Opioids

Relapse prevention: Alcohol Opioids Tobacco Overdose reversal: Naloxone VETERANS HEALTH ADMINISTRATION Opioid Prescribing Increased 1991 - 2011

Volkow 04/02/2014 - Testimony http://www.drugabuse.gov/about-nida/legislative-activities/testimony-tocongress/2014/harnessing-power-science-to-inform-substance-abuseVETERANS HEALTH ADMINISTRATION addiction-policy-practice 18,893 deaths from prescription opioid pain relievers in 2014 10,574 deaths from heroin in 2014 One strategy to mitigate opioid drug overdose deaths includes increasing the accessibility and utilizing of Naloxone Naloxone is a safe and effective antidote for opioid-related overdose that has been used for more than 40 years.

Naloxone has no abuse potential and can reverse a life-threatening overdose by blocking the opioids effects, restoring breathing and preventing death. Opioid overdose prevention programs In 1996, Community-based programs began distributing naloxone directly to patients at high risk for overdose Programs have since expanded to provide overdose training and naloxone kits to laypersons who might witness an opioid overdose in efforts to reduce opioid overdose mortality in these areas These programs have since shown to be safe and costeffective by providing naloxone kits to 152,283 laypersons and received reports of 26,463 overdose reversals

Naloxone Rescue Kit Contents Naloxone Rescue Kit IM VETERANS HEALTH ADMINISTRATION Naloxone Rescue Kit Nasal Naloxone Autoinjector- Evzio Video available at Evzio website: http://www.evzio.com/hcp/ VETERANS HEALTH ADMINISTRATION 60

Ongoing Efforts to Increase the Accessibility of Naloxone Legislation and Government Policy Laws being amended or enacted to increase accessibility to Naloxone and Encourage persons to summon medical assistance in case of an overdose Naloxone Access Laws provide civil immunity to prescribers, permit third-party prescribing or permit prescribing via standing order Good Samaritan Laws aim to protect persons who provide assistance during an overdose from prosecution or criminal repercussions Naloxone Overdose Prevention Laws: PDAPS Prescription Drug Abuse Policy System Report February 2016

Prevention Strategies to Address the Opioid Epidemic Include: Clinical guidelines to educate physicians Mandatory addiction education in medical, nursing and pharmacy schools Continued development of use prescription-drug monitoring programs Providing safe and efficient ways to dispose of medication Abuse-deterrent formulations Enforcement policies to discourage diversion

Treatment Strategies Include: Efforts to de-stigmatize addiction and treatment o Education and public awareness Increasing access to evidence based treatment o Reimbursement, insurance coverage, number of treatment programs Expanding medication assisted treatment o (suboxone, naltrexone, methadone) o Number of providers willing to treat and provide these medications Increased psychosocial and recovery support o Counseling, mental health, family involvement, monitoring services for extended periods of treatment Ongoing research to evaluate current treatment strategies and

help direct future care Increased availability and utilization of Naloxone to reduce the number of opioid related overdose deaths Treatment Strategies Include: Efforts to de-stigmatize addiction and treatment o Education and public awareness Increasing access to evidence based treatment o Reimbursement, insurance coverage, number of treatment programs Expanding medication assisted treatment o (suboxone, naltrexone, methadone) o Number of providers willing to treat and provide these medications Increased psychosocial and recovery support

o Counseling, mental health, family involvement, monitoring services for extended periods of treatment Ongoing research to evaluate current treatment strategies and help direct future care Increased availability and utilization of Naloxone to reduce the number of opioid related overdose deaths Tobacco Use Disorders (TUD) Leading preventable cause of premature death in the United States. Patients with alcohol use disorder (AUD) more likely to die of TUD than AUD.

Treatment works: Brief counseling Counseling plus medication most effective Combined medication may be more effective than a single agent Nicotine patch and gum Nicotine patch and bupropion VETERANS HEALTH ADMINISTRATION Pharmacotherapy Nicotine replacement Gum Transdermal patch Nasal spray Inhaler Bupropion (Zyban, Wellbutrin)

Varenicline (Chantix) VETERANS HEALTH ADMINISTRATION Nicotine Gum Available OTC 4 mg and 2 mg Usual dose: 10 15 pieces per day Proper chewing technique is key: Chew until tingling or pepper taste Park between cheek and gums No food or drink while chewing Side effects: Nausea, indigestion

Efficacy: OR = 1.4 1.6 VETERANS HEALTH ADMINISTRATION Transdermal Nicotine Patch Available OTC 22, 21, 14, 11, 7 mg over 24 hours 15 mg over 16 hours Usual dose 21/22 mg/day x 4 8 weeks Dose reduction every 2 4 weeks Abstinence in first two weeks is key Side effects Local skin irritation, ? Insomnia

Efficacy- O.R. = 2.1 VETERANS HEALTH ADMINISTRATION Transdermal Nicotine Dose Based on Reported Smoking Cigarettes per day Initial Patch Dose < 10 7 14 mg/day 10 20

14 22 mg/day 21- 40 22 44 mg/day >40 >44 mg/day VETERANS HEALTH ADMINISTRATION Bupropion (Zyban, Wellbutrin) Monocyclic antidepressant available by prescription Inhibits reuptake of NE and DA

Antagonist at nAChr Usual dose 150 mg/day x 3, then 150 mg twice daily Adverse events Seizure risk (0.1%) Insomnia, dry mouth, hypertension Efficacy- O.R. = 1.4 2.35 VETERANS HEALTH ADMINISTRATION Bupropion (Zyban, Wellbutrin) Monocyclic antidepressant available by prescription Inhibits reuptake of NE and DA

Antagonist at nAChr Usual dose 150 mg/day x 3, then 150 mg twice daily Adverse events Seizure risk (0.1%) Insomnia, dry mouth, hypertension Efficacy- O.R. = 1.4 2.35 VETERANS HEALTH ADMINISTRATION Varenicline (Chantix) Partial agonist at alpha4beta2 nicotinic cholinergic receptor Usual dose: 1 mg twice daily Adverse events: nausea (30%), insomnia (18%),

headache (15%), abnormal dreams (13%) Efficacy: OR = 3.08- 3.85 VETERANS HEALTH ADMINISTRATION Varenicline versus Bupropion or Placebo for Smoking Cessation VETERANS HEALTH ADMINISTRATION Gonzalez et al: JAMA 2006;296:47-55 Conclusions

Counseling plus medication more effective than counseling alone Medications save lives compared to counseling alone Imminent risk of opioid overdose death after detoxification Significantly reduced risk of mortality for alcohol Significantly improved success in quitting tobacco over counseling alone Persons with alcohol, opioid, and tobacco use disorders should receive medication as part of comprehensive treatment for a complex, multifactorial illness. Part of the functional analysis of relapse should include assessment of medication or lack of medication as part of treatment at the time of relapse.

VETERANS HEALTH ADMINISTRATION Resources MHS SUD SharePoint: https://vaww.portal.va.gov/sites/OMHS/SUD/default.aspx Academic Detailing AUD Campaign: https://vaww.portal2.va.gov/sites/ad/SitePages/AUD.aspx

Pharmacy Benefits Management- Recommendations for Use https://vaww.cmopnational.va.gov/cmop/PBM/default.asp VA DoD Clinical Practice Guidelines for Management of SUD http://www.healthquality.va.gov/guidelines/MH/sud/ VETERANS HEALTH ADMINISTRATION 77

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