Transcript 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
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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
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Overview
• Why medications?
• Withdrawal management:
– Alcohol
– Opioids
• Relapse prevention:
– Alcohol
– Opioids
– Tobacco
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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
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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).
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Interconnected Networks Mediating
Motivation and Decision-making
George Koob, PhD
(2013)
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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
– Compliance with diet
• Retreated within 12 months
<30%
<30%
50 – 60%
• Substance use disorders
– Compliance with treatment attendance
<40%
• Retreated within 12 months
10 – 40%
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O’Brien CP, McLellan AT. Lancet. 1996;347:237-240.
Overview
• Why medications?
• Withdrawal management:
– Alcohol
– Opioids
• Relapse prevention:
– Alcohol
– (Cocaine)
– Opioids
– Tobacco
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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
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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
Myrick H, Anton R. CNS Spectrums.
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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
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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)
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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.
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•
•
•
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.
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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.
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Overview
• Why medications?
• Withdrawal management:
– Alcohol
– Opioids
• Relapse prevention:
– Alcohol
– Opioids
– Tobacco
• Overdose reversal:
– Naloxone
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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
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Oral Naltrexone in the treatment of
alcohol dependence
Volpicelli et al: 1992 Arch Gen Psych 49(11):876-80
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Oral Naltrexone Reduces Relapse
to Heavy Drinking
Source
Duration
in weeks
Bias
Risk
Tx Group
Control
Event/ No event
Event/ No event
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Risk
Difference
Favors
treatment
Favors
control
%
weight
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Oral Naltrexone Supports
Abstinence from Alcohol
Source
Duration
in weeks
Bias
Risk
Tx Group
Control
Event/ No event
Event/ No event
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Risk
Difference
Favors tx
Favors
control
Jonas et al: 2014, JAMA
%
weight
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Oral Naltrexone
Injectable Naltrexone (Vivitrol)
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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-39:79–83
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Naltrexone Precautions
Contraindications
Precautions
Drug interactions
Use of opioids
Acute opioid
withdrawal
Anticipated need
for opioid
analgesics
Acute hepatitis or
liver failure
Liver disease
Depression
History of suicide
attempts
Injection site
reactions
Pregnancy Cat C
Opioid analgesics
(blocks action)
Thioridazine
(increased
somnolence)
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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
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Acamprosate (Campral)
Acamprosate Supports Abstinence
in Alcohol Use Disorder
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Jonas et. al
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Acamprosate Precautions
Contraindications
Precautions
Drug interactions
Severe kidney
disease
(CrCl <30mL/min)
Moderate kidney
disease
Depression
History of suicide
attempts
Pregnancy Cat C
None known
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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
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Pharmacotherapy for Adults With Alcohol Use Disorders in
Outpatient Settings----A Systematic Review and Metaanalysis
•
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
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Serious:
Alcohol-disulfiram
reaction
Hepatitis
Neuropathy
Psychosis
Disulfram (Antabuse)
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
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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
1Hser
(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
Precautions
Drug interactions
Allergy to
methadone
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
Precautions
Drug interactions
Allergies to
buprenorphine or
naloxone
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
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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.
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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
100-150 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
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Improved Abstinence from Opioids and Reduced
Craving with Extended-Release Naltrexone (XRNTX) vs Placebo
VETERANS HEALTH ADMINISTRATION
2011-Krupitsky et al-Lancet- 377:1506
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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
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Naloxone Rescue Kit Nasal
Naloxone Autoinjector- Evzio
•
Video available at Evzio website: http://www.evzio.com/hcp/
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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
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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/
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