Treating Alcohol Use Disorders With Prescriptions And Medications

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1 Medications for Treatment of Substance Use Disorders (SUDs) Karen Drexler, MD Deputy National Mental Health Program Director- Addictive Disorders Office of Patient Care Services Department of Veterans Affairs

2 Disclosures Employed by the Department of Veterans Affairs (VA) No commercial financial conflicts of interest

3 Learning objectives The participant will be able to: Understand substance use disorders as chronic brain diseases. Understand research evidence supporting medications to improve treatment outcome. Become familiar with medications available to treat alcohol use disorders and opioid use disorders- mechanisms of action risks and benefits other clinical considerations

4 Overview Why medications? SUD-specific medications for relapse prevention: Alcohol Opioids

5 Why Medications? SUDs are chronic brain diseases Multifactorial, like other chronic diseases Respond best to comprehensive treatment Medications improve treatment outcome over psychosocial interventions alone Reduce craving and risk of relapse Protect against opioid overdose

6 DSM-5 Substances 10 categories Alcohol Caffeine Cannabis Hallucinogens (PCP) Inhalants Opioids Sedatives, Hypnotics, and Anxiolytics Stimulants (amphetamines, cocaine, etc.) Tobacco Other or unknown 6

7 DSM-5 Substance Use Disorder >/= 2 of the following 11 criteria within 12-months: 1. Taking larger amounts than intended 2. Persistent desire/efforts to cut down or control 3. Great deal of time spent getting the substance, taking it, or recovering 4. Craving, strong desire or urge 5. Failure to fulfill major role obligations due to use 6. Recurrent hazardous use 7. Important activities given up or reduced 8. Continued use despite a psychological or physical problem 9. Continued use despite a social or interpersonal problem 10. Tolerance 11. Characteristic withdrawal 7

8 Compliance and Relapse in Chronic Medical Disorders Insulin-dependent diabetes Compliance with medication <50% Compliance with diet and foot care <30% Retreated within 12 months 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% O Brien CP, McLellan AT. Lancet. 1996;347:

9 Effectiveness of Treatment in Hypertension +Med A - Med A BP>140/90 BP<120/80 BP>140/90

10 Effectiveness of Treatment in SUD treatment Tx - Tx Daily substance use Abstinence or reduced substance use Daily substance use

11 Interconnected Networks Mediating Motivation and Decision-making George Koob, PhD (2013)

12 Addicting Drugs Hijack Decision-making pathways Mesolimbic dopaminergic pathway Activated by food, sex, threat, and powerfully by addicting drugs Connected to memory circuits Through classical and operant conditioning, cues activate dopamine Through extinction, cues gradually become less activating However, reinstatement is predictable- Food is seasonal Cues, stress, drugs Thus, HALT from AA When a cue signals availability, automatic behavioral cascade is initiated. Cunning, baffling, powerful 12

13 Cocaine Microdialysis in Awake Squirrel Monkeys Howell L

14 Why Medications? Summary Substance use disorders are chronic, brain diseases. Untreated, they lead to premature death and contribute to recidivism. SUDs involve changes in neural pathways involved in motivation, drive and decision-making. These neural changes are enduring, but respond to long-term treatment Similar to treatment of hypertension or Type 2 Diabetes Mellitus Medications and psychosocial treatments can save lives 14

15 Overview Why medications? Relapse prevention: Alcohol Opioids

16 FDA Approved Medications for SUDs Alcohol use disorder: Naltrexone (Revia, Vivitrol ) Disulfiram (Antabuse ) Acamprosate (Campral ) Opioid use disorder: Methadone Buprenorphine/naloxone (Suboxone ) Naltrexone (Vivitrol ) Opioid overdose: Naloxone rescue kits and Evzio

17 Case #1 44 year-old man with 25-year history of severe alcohol use disorder. Unable to abstain from alcohol outside a controlled environment for >30 days. Reported urges to drink alcohol triggered by the sight of empty beer cans on roadside. Began oral naltrexone at the end of inpatient detoxification. Reduction in alcohol craving. Tested medication by driving to favorite bar and sitting outside in parking lot. No craving. Able to drive home without relapsing. 17

18 Naltrexone (ReVia, Vivitrol ) Mu opioid antagonist Craving reduction Decreased euphoria (enhances extinction?) Reduces risk of relapse to heavy drinking if slip occurs Usual dose: Oral - 50 mg 100 mg once daily, Intramuscular mg/month Adverse events: Nausea, abdominal cramps Muscle aches, headache Insomnia, depression, anxiety May precipitate opioid withdrawal in tolerant individuals Renders opioid pain medications ineffective Injection site reactions for injectable form (Vivitrol ) Adverse events tend to occur early, if at all, minimized by establishing alcohol abstinence prior to starting medication.

19 Oral Naltrexone in the treatment of alcohol dependence Volpicelli et al: 1992 Arch Gen Psych 49(11):876-80

20 Oral Naltrexone Supports Abstinence from Alcohol Jonas et al: 2014, JAMA 20

21 Oral Naltrexone Reduces Relapse to Heavy Drinking 21

22 Extended Release Naltrexone Injection Associated with Reduced Mortality and Hospital Readmissions Outcome measure 1 year mortality Odds Ratio for NTX-XR/control 0.30 (p < 0.001) In subset with detox in prior year Subsequent detox episodes 0.80 (p < 0.001) Case-Control design 387 veterans with AUD received NTX-XR 3759 controls Propensity score weighted, mixed-effects logistic regression model for 1-year mortality. For subset with at least one detox episode in previous year, # detox episodes in following year. 1 year mortality 0.78 (p < 0.001) Harris et al Alcohol Clin Exp Res-39:

23 Naltrexone Precautions Contraindications Precautions Drug interactions Use of opioids in last 7 to 10 days Acute opioid withdrawal Anticipated need for opioid analgesics Acute hepatitis or liver failure Hypersensitivity Failed naloxone challenge Acute liver disease Severe kidney failure Monitor for emergence of depression Injection site reactions (extended release injection only) Pregnancy Category C Opioid analgesics (blocks action and can induce withdrawal)

24 Acamprosate (Campral ) Modifies glutamate NMDA receptor function Advantage in patients with liver disease- eliminated through the kidney Helps maintain abstinence in those who have stopped drinking alcohol No benefit in reducing heavy drinking or inducing abstinence Usual dose: 333mg: 2 tablets 3 times daily Adverse events: Rare: suicidal ideation and behavior Common: diarrhea (>10%), Others: insomnia /sleepiness, anxiety

25 Acamprosate Supports Abstinence in Alcohol Use Disorder Jonas et al: 25

26 Acamprosate Precautions Contraindications Precautions Drug interactions Severe kidney disease (CrCl <30mL/min) Moderate kidney disease Depression History of suicide attempts None known

27 Case #2 42 year-old married, full-time mother of two with strong family history of alcohol use disorders. Mother died from her alcoholism when she was a teen. Unable to stay sober after 28-day inpatient treatment program. Naltrexone started after second 28-day program, but had no effect on craving. Relapsed on naltrexone 2 months after starting the medication. Highly motivated for sobriety to save marriage, children. Functional analysis of relapse identified unavoidable risky situations Social functions Family gatherings Discussed risks/benefits of disulfiram. Agreed to have husband monitor her selfadministration. Sober 12 months on disulfiram. 27

28 Disulfiram (Antabuse ) Inhibits aldehyde dehydrogenase build-up of toxin (acetaldehyde) Active for up to 2 weeks. Patients must understand risk of relapse to alcohol. Usual dose: 250 mg once daily Adverse reactions: Common: Metallic or garlicky taste Drowsiness Serious: Alcohol-disulfiram reaction can be fatal Hepatitis Neuropathy Psychosis

29 Disulfiram not different than placebo in double-blind RCTs 29

30 Disulfiram Effective in Open-Label, Not Blinded RCTs 30

31 Disulfiram Best with Supervised Administration 31

32 Disulfiram Precautions Contraindications Precautions Drug interactions Recent alcohol use Cardiovascular disease Allergy to rubber (thiuram) derivatives Liver disease Psychosis Epilepsy Hypothyroidism Diabetes mellitus Kidney disease Carry wallet card Alcohol (cough syrups, mouthwash, wine sauce, etc.) Anticoagulants (Coumadin) Isoniazid Metronidazole Phenytoin

33 Alcohol Medications Summary FDA-approved medications for Alcohol Use Disorder (AUD, DSM5): Acamprosate delayed-release oral tablets (CAMPRAL and generic) Naltrexone oral tablets (REVIA and generics) Naltrexone extended-release suspension for intramuscular injection (VIVITROL) Disulfiram oral tablets (ANTABUSE and generics) None of these medications is consistently superior to the others Overall, they produce small to moderate benefits. Treatment response with the oral agents better in patients who are already abstinent before starting therapy. Abstinence required prior to disulfiram. In clinical trials, AUD-focused pharmacotherapy was usually provided with addiction-focused counseling. 33

34 Opioid Use Disorder High mortality 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% Counseling alone modestly effective Therapeutic community Contingency management Medications: Opioid Agonist Therapy (OAT) has strong evidence of effectiveness: Mu opioid agonist (methadone) Mu opioid partial agonist (buprenorphine) Opioid Antagonists have fair evidence of efficacy: Mu opioid antagonist (injectable naltrexone) for relapse prevention Mu opioid antagonist (naloxone) for overdose reversal 1 Hser (2001) Arch Gen Psych 58:

35 Opioid Prescribing Increased Volkow 04/02/ Testimony

36 Case #3 62 year-old man former convicted felon in stable marriage x 12 years. Regular cannabis, tobacco, and alcohol user who became addicted to prescription opioid pain medications prescribed for chronic low back pain. Wife diagnosed with terminal cancer. Presented with suicidal ideation when he took his wife s pain medications to feed his addiction to opioids. Discussed risks/benefits of buprenorphine/naloxone for treatment of opioid use disorder. Agreed to a trial. Able to support wife through hospice care without further diversion of her medication. Negotiated her death and contentious legal battle over her estate without relapse to opioids, alcohol or cannabis. Paranoia secondary to cannabis, resolved when able to abstain from all substances except tobacco. Antipsychotic medications discontinued without recurrent paranoia. Able to control back pain with Tai Chi. 36

37 Methadone versus Buprenorphine on OUD Treatment Outcomes Outcomes Treatment Retention Positive UDT for morphine Self-reported heroin use Relative effect (95% CI) RR = 0.83 (0.75 to 0.95) SMD = ( ) SMD (-0.28 to 0.07) UDT + benzos SMD 0.10 (-0.05 to 0.25) UDT + cocaine SMD 0.05 (-0.09 to 0.18] # of studies (# participants) 11 (1391) 5 double-blind (788) 6 open-label (603) Quality of Evidence High Comments Greater retention in methadone group 8 (1027) Moderate No difference 4 (501) Moderate No difference 6 (919) Moderate No difference 6 (859) Moderate No difference Mattick RP et al: Cochrane Review 2014

38 Methadone Mu opioid agonist Usual dose: mg once daily Efficacy: 1.72 (high dose vs low dose (<60 mg) Must be administered through Federally Regulated Narcotic Treatment Program Daily clinic dosing for first 90 days Adverse reactions: Common: Constipation Drowsiness Low T Hyperalgesia Serious: Cardiac arrhythmias Sudden cardiac death

39 Methadone Precautions Contraindications Precautions Drug interactions Allergy to methadone Heart disease Head injury Sedativesnarcotics, anesthetics, benzodiazepines, phenothiazines CYP3A4 inhibitors may levelsketoconazole, erythromycin, HIV protease inhibitors

40 Buprenorphine/Naloxone (Suboxone ) Partial opioid agonist/parentally active antagonist Usual dose: 4-24 mg of buprenorphine once daily Efficacy: >8mg daily similar to methadone Prescriber must possess DATA 2000 waiver (DEA X-number) Adverse reactions: Common: Drowsiness Constipation Serious: Cardiac arrhythmia- prolongs QTc Cytolytic hepatitis

41 Buprenorphine Precautions Contraindications Precautions Drug interactions Allergies to buprenorphine or naloxone Head injury- may increase intracranial pressure CNS depression- Caution in operating heavy machinery CNS depressantsnarcotics, anesthetics, benzodiazepines, phenothiazines CYP3A4 inhibitors may levelsketoconazole, erythromycin, HIV protease inhibitors

42 Short Buprenorphine Taper versus Extended Buprenorphine Methods: 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; those 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. Weiss R et al: Arch Gen Psychiatry 42

43 Active Buprenorphine Maintenance Improves Odds of Successful Recovery versus No Treatment Weiss R et al: 2011;Arch Gen Psych 43

44 Extended-Release Injectable Naltrexone (Vivitrol ) Mu opioid antagonist Blocks euphoria Reduces risk of overdose, if slip occurs Usual dose: Intramuscular mg/month (4 weeks) Adverse events: Nausea, abdominal cramps Muscle aches, headache Insomnia, depression, anxiety May precipitate opioid withdrawal in tolerant individuals Renders opioid pain medications ineffective Injection site reactions Adverse events (other than injection site) may be less than with oral form.

45 Improved Abstinence from Opioids and Reduced Craving with Extended-Release Naltrexone (XR-NTX) vs Placebo 2011-Krupitsky et al-lancet- 377:

46 Medications for Opioid Use Disorder Summary Methadone and buprenorphine are first-line treatment for opioid use disorders Methadone better for treatment retention Buprenorphine/naloxone more widely available Both opioid agonist therapy (OAT) medications consistently and significantly improve outcome versus placebo, no treatment, or oral naltrexone Extended-release Injectable Naltrexone Superior to placebo in double-blind, randomized clinical trial. Further research needed to directly compare to OAT Due to poor efficacy of psychosocial interventions alone and high mortality associated with opioid overdose, psychosocial interventions alone are not recommended for opioid use disorders. 46

47 Drug Overdoses- Leading Cause of Injury Deaths in US 47

48 NUMBER OF DEATHS 50,000 45,000 Major Causes of Death from Injury, MOTOR VEHICLE ACCIDENTS % CHANGE 2008 to % 40,000 35,000 30,000 SUICIDE FIREARMS + 14% -11% + 6% 25,000 DRUG POISONING 20,000 15,000 HOMICIDE -10% 10,000 5,000 1/ Source: Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death on CDC WONDER Online Database, released Data for 1999 to 2012 were extracted by ONDCP on December 2, Data for 2013 are from Detailed Tables for the National Vital Statistics Report Deaths: Final Data for 2013 (December 30, 2014). 48

49 Number of Deaths Drug Poisoning Deaths Involving Opioid Analgesics, Cocaine and Heroin: United States, ,000 16,000 % CHANGE 2010 to % 14,000 12,000 10,000 8,000 6,000 4, % +18% 1/2015 2, opioid analgesic 4,030 4,400 5,528 7,456 8,517 9,857 10,92 13,72 14,40 14,80 15,59 16,65 16,91 16,00 16,23 cocaine 3,822 3,544 3,833 4,599 5,199 5,443 6,208 7,448 6,512 5,129 4,350 4,183 4,681 4,404 4,944 heroin* 1,963 1,843 1,784 2,092 2,084 1,879 2,010 2,089 2,402 3,041 3,278 3,036 4,397 5,927 8,260 Note: Not all drug poisoning deaths specify the drug(s) involved, and a death may involve more than one specific substance. The rise in in opioid deaths is related to non-pharmaceutical fentanyl (see *Heroin includes opium. Source: Centers for Disease Control and Prevention, National Center for Health Statistics [NCHS]. Multiple Cause of Death on CDC WONDER Online Database, released Data for 1999 to 2012 were extracted by ONDCP on November 20, Data for 2013 are from unpublished analysis by NCHS December 30, 2014). 49

50 Overdose Risk in Veterans Similar to US civilians, opioid overdose deaths increased among veterans from 2001 to Increase in overdose deaths correlates with increases in opioid prescribing. Variations in state level opioid prescribing correlate with variations in opioid overdose deaths (r = 0.29). Bohnert A et al: JAMA 2011;305(13): Bohnert A et al: Clin J Pain 2014;30(7):

51 Opioid Overdose Signs and Symptoms Opioid drugs activate opioid receptors in the brain and body and causes: Euphoria Pain relief Decreased bowel motility Somnolence High doses of opioid drugs can lead to: Coma Death from stopping breathing Signs of opioid overdose include: Extreme sleepiness, inability to arouse even if shaken. Snoring, gurgling sounds, labored breathing. Slow heart rate, pin point pupils Pale, clammy skin, blue lips and fingernails from lack of oxygen. 51

52 Naloxone (Evzio ) Opioid antagonist (blocker) Naloxone auto-injector (IM or SC) fast-tracked by the FDA for emergency treatment of opioid overdose for administration by laypersons. Approval was based on bioequivalence study with the naloxone syringe; no clinical safety or efficacy studies were required by the FDA. The main advantages of the naloxone auto-injector over naloxone kits include Simplicity of use; Compact size and sturdy case; A retractable needle that may reduce the risks of accidental needle sticks and reuse of the syringe for injection drug use; Potential disadvantages include restriction to IM or SC route of administration, lack of human factor testing in non-english speaking individuals. 52

53 Evzio 53

54 Naloxone Rescue Kit Contents Naloxone Rescue Kit IM Naloxone Rescue Kit Nasal

55 Conclusions Counseling plus medication more effective than counseling alone Medications save lives Imminent risk of opioid overdose death after detoxification Significantly reduced risk of mortality for alcohol Veterans with alcohol and opioid use disorders should receive medication as part of comprehensive treatment for a complex, multifactorial illness.

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