Download Medication Assisted Treatment

Overview of the Program
Medication Assisted (Supported) Treatment
Michael Delman MD, FACP, FASCG, FASAM
Assistant Professor of Medicine
Hofstra North Shore-LIJ School of Medicine
Credits
Stephen A. Wyatt, D.O.
Dept. of Psychiatry Middlesex Hospital Middletown, CT
Edwin A. Salsitz, M.D., FASAM
Mount Sinai Beth Israel
Stages of the Addiction Cycle.
Volkow ND et al. N Engl J Med 2016;374:363-371.
Medications Approved for Alcohol Addiction
Disulfiram
It is most effective in people who have already gone through detoxification or are in the initial stage of
abstinence. This drug is offered in a tablet form and is taken once a day. Disulfiram should never be taken
while intoxicated and it should not be taken for at least 12 hours after drinking alcohol. Unpleasant side
effects (nausea, headache, vomiting, chest pains, difficulty breathing) can occur as soon as ten minutes
after drinking even a small amount of alcohol and can last for an hour or more.
Acamprosate
Acamprosate is a medication for people in recovery who have already stopped drinking alcohol and want to
avoid drinking. It works to prevent people from drinking alcohol, but it does not prevent withdrawal
symptoms after people drink alcohol. The use of acamprosate typically begins on the fifth day of abstinence,
reaching full effectiveness in five to eight days. It is offered in tablet form and taken three times a day,
preferably at the same time every day. The medication’s side effects may include diarrhea, upset stomach,
appetite loss, anxiety, dizziness, and difficulty sleeping.
Naltrexone
When used as a treatment for alcohol dependency, naltrexone blocks the euphoric effects and feelings of
intoxication. This allows people with alcohol addiction to reduce their drinking behaviors enough to remain
motivated to stay in treatment, avoid relapses, and take medications.
Objectives
• Review the development, science and prescribing
policies of the currently available medications for the
treatment of opiate dependence.
• Understand the factors important in the decision of
which treatment would be indicated.
• Understand the factors associated with the initiation of
a treatment for opiate dependence.
Current
Treatments
Medically assisted withdrawal and abstinence.
•
Methadone maintenance
•
Naltrexone: oral and injectable
•
Buprenorphine/naloxone
MEDICATION ASSISTED
ADDICTION 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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Historical Review
• The 1914 Harrison Act was a commerce act
restricting the sales of narcotics, it excluded
physicians treating patients
• In 1919 when the Harrison Act was ratified by the
Supreme Court it excluded the treatment of opiate
dependence: not considered a disease.
‐ No longer was it legal for physicians to prescribe
opiates for maintaining opiate dependence or for the
treatment of the disease.
‐ Medically assisted withdrawal of opiates and
abstinence was the only legal treatment.
• The historical records identify the relapsing nature
of this disease.
Historical Review
the death rate from heroin injectors continued to rise in the late
 As
1950’s and early 1960’s, with a concurrent rise in associated crime,
there was growing support for the establishment of opiate
maintenance programs.
was an increase in federal funding for research into treating
 There
these patients.
1962 Vincent Dole, MD received a grant to study the feasibility of
 In
opiate maintenance treatment. In 1964 Marie Nyswander, MD, a
psychiatrist with experience in treating addicted patients joined the
research team.
was eventually selected as the most efficacious opiate for
 Methadone
maintenance treatment.
Neurobiology: Methadone
Neurobiology: Methadone
• Blocks the euphoric and sedating effects of other opiates
• Reduces the craving for other opioids
• Relieves symptoms associated with withdrawal from opiates
• With stable dosing tolerance develops and does not cause
euphoria or intoxication, thus allowing a person to participate in
normal daily activities including employment and family
responsibilities
• Has a long half-life and is excreted slowly, allowing for once
daily dosing.
Methadone Maintenance Treatment:
A treatment program in which addicted individuals receive
daily doses of methadone
Multi-component treatment program
•
•
•
•
•
Encourages abstinence from other drugs of abuse including alcohol
Resocialization – Sober supports
Vocational training
Coordination of healthcare • HIV
Hepatitis C • Pregnancy
Identified
Benefits
of
MMT
Methadone Treatment
•
‐ reduced
risk of overdose
‐reduced or stopped use of injection drugs;
‐reduced mortality – the median death rate of opiate-dependent
individuals in MMT is 30 percent of the rate of those not in MMT;
‐reduced risk of acquiring or transmitting diseases such as HIV,
hepatitis B or C, bacterial infections, endocarditis, soft tissue
infections, thrombophlebitis, tuberculosis, and STDs;
‐reduced criminal activity;
‐possible reduction in sexual risk taking
‐ Improved employment potential;
‐ improved family stability
‐ improved pregnancy outcomes
Retention in Treatment Relative to Dose
Relative Risk of Leaving Treatment
80 + mg
60-79 mg
< 60 mg
(Baseline)
Adapted from Caplehorn & Bell
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Methadone Treatment
• Drawbacks
 ‐ Physical dependence, possibly strengthening
neurobiological adaptation to opiate
dependence.
 ‐ Daily administration at a licensed methadone
treatment center is required in initial phase of
treatment
 ‐ Early mild to moderate opiate like effects; e.g.
sedation, reduction in cognitive awareness
 ‐ Long term maintenance effects on hormonal
adaptations; reductions in testosterone, menstruation,
calcium metabolism
 ‐ Drug/drug interactions
 ‐ Neonatal abstinence syndrome in babies born
to methadone-maintained mothers
Historical Review
• The next approved medication for opiate
dependence was naltrexone approved in 1984.
• As an opiate antagonist it blocks the opiate
receptor significantly changing the response to the
administration of an opiate.
‐
The lack of compliance and less reduction in
craving are thought to be the prominent
problems associated with poor efficacy of the
oral product.
• A sustained release form was determined to have
an adequate safety profile and to be effective by
the FDA in 2010.
Neurobiology: Naltrexone
Binds to the opiate receptor without activation
•
Available as both oral and injectable formulations.
‐ Oral typically daily administration, however may be given on a three
times per week schedule (Monday: 100 mg – Wednesday: 100 mg –
Friday: 150 mg)
Injectable form is given once monthly.
• Evidence of reduction in opiate craving through a
combination of;
‐ Reduced opiate receptor activation due to partial endorphins
blockade
‐ Total blockade reducing initial consideration of opiate use.
• Injectable product resulting more positive results
Naltrexone Treatment
Drawbacks
 Blockade of opiate receptors interferes with
opiate analgesia
 Opiate dependent patients must be
detoxified from opiates before naltrexone
can be started
 Compliance is the major drawback to the oral
product.
 Injectable requires continued patient
compliance after detoxification until
administration.
Historical Review
• With the establishment of DATA 2000 another
treatment option was made available.
‐ This act of Congress established that any schedule
III, IV, V controlled substance with FDA approval for
treatment of opioid dependence could be prescribed
by a “qualified” physician.
• This opened the door to buprenorphine products
which are placed on schedule III.
• This resulted in availability of office based opiate
dependent treatment with an agonist medication.
• This further broadened the availability of
maintenance treatment.
Neurobiology: Buprenorphine
• Opioid Partial agonist
 ‐ High affinity for mu opioid receptor
 ‐ Slow dissociation from receptor
 ‐ Displaces other opioids from mu
receptor including Heroin
 ‐ Improved safety profile due to reduction
in potential respiratory depression
Buprenorphine Treatment
• Approved for office based treatment
‐ Allows for normalization of treatment in the primary care or
behavioral health care settings.
‐ Allows for wider availability of agonist treatment for opioid
dependence
• Opioid partial agonist properties reduce potential for overdose
• Once a day administration
• Fewer drug interactions described than for methadone
currently
• Relative blocking of other opiates
• Significant reduction in craving
• Improved reentry into normal socialization
• Helps to shift from drug abusing behavior to normal life
activities
Buprenorphine Treatment
• Drawbacks
 ‐ Physical dependence, possible strengthening of the opiate
dependence
 ‐ Potential diversion for abuse
 ‐ Reduces the patients drive to put in place relapse prevention
behaviors due to the pharmacologic reduction in the drive to
use other opiates.
 ‐ There is evidence of both hormonal adaptation.
 - Neonatal abstinence syndrome can occur in babies born to
mothers maintained on buprenorphine though less than that
seen in the methadone treated patient.
Treatment Selection
• Logistical considerations
 Lack of access to a methadone treatment center has been a
major limitation to this form of treatment
 Buprenorphine has limitations in access due to a lack of
waivered physician availability though office based treatment
has improved treatment access in rural areas in particular.
 Does a physician prescribing buprenorphine/naloxone have
access to assistance with drug counseling in their
community?
 Need for detoxification from opiates prior to the
administration of naltrexone. Can be a challenge due to
relapse potential in the period following last dose of opioid
and time necessary for opioid to be eliminated and physical
dependence to resolve.
Treatment Selection
There is significant overlap in the indications of one form of therapy over another.
Patients may have a strong bias to one form of treatment over another.
Honoring this when possible may improve compliance and effectiveness.
Physician knowledge and level of comfort will also be a consideration.
Patients with co-occurring medical or psychiatric illness need special consideration.
Poly substance abuse may need the daily oversight provided by MMT
The opportunity for the pregnant patient to be treated in an established
methadone maintenance pregnancy program should be strongly considered if
available.
Buprenorphine has been shown to reduce both days of hospitalization for NAS and
morphine dose need for treatment of NAS following delivery.
Cost
• Comparison of medication assisted treatment vs. no
medication for inpatient, outpatient, and pharmacy costs
‐ 29% lower for patients who received a medication for
opioid dependence versus patients treated without
medication.
• Injectable sustained release naltrexone had fewer opioidrelated and non–opioid-related hospitalizations than patients
receiving oral medication.
• Total healthcare costs were not significantly different between
oral or injectable naltrexone and buprenorphine/ naltrexone
and were 49% lower than those for methadone.
‐ This in part was a reflection on the increased comorbidities in the methadone population.
Baser, AJ of Managed Care, 2011
Medically Assisted Opioid
Treatment
• Abstinence remains an option particularly in
the young person or those with a low level of
dependence.
• However:
‐ There is strong evidence of improved outcomes
with medication assisted maintenance treatment
‐ Patients should be made aware of their options
‐ Treatment providers should be aware of these
medications to better educate patients and make
appropriate treatment recommendations.
Final Comments: OAT Duration
• The scientific evidence base, and 50 years of clinical
experience overwhelmingly support maintenance in the
OAT treatment paradigm.
• The goal of OAT maintenance is not to see how fast a
patient can “get off” medication.
• The goal is normalization and stabilization of the brain,
establishing durable and safe hedonic tone, and
functioning at maximal potential at home and at work.
• Like most chronic medical therapies, the medication only
works, when it is taken.
• “If It Ain’t Broke, Why Fix It?
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MEDICATION ASSISTED
ADDICTION TREATMENT
“All Treatments Work For Some People/Patients”
“No One Treatment Works for All People/Patients”
If your treatment is working, keep doing the treatment
If your treatment is not working, change your treatment!!
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