Clinical Practice in Opioid Treatment

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Clinical Practice in Opioid Treatment

• Elaine Tophia, Ph.D., CMOTC, SAM

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• Opioid Treatment programs often face
  unprecedented challenges that require good
  clinical practice. This is increasingly tied to
  the need for more sophisticated, more
  comprehensive, more efficient program operations.
  Opioid Treatment programs with top clinical
  treatment teams can struggle and even fail if
  staff members are not well trained in the
  specifics of Opioid Treatment and the
  organization is not well managed. This training
  establishes the foundation for substance abuse
  counselors, supervisors and administrators
  working in or aspiring to work in an Opioid
  Treatment setting or interested in the required
  day to day operations of a treatment center.

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Course Objectives

• To gain an understanding of some history and
  research regarding Opioid Treatment
• To make a distinction between methadone
  maintenance and Opioid Treatment

• Experience and appreciate the effectiveness of
  Opioid Treatment.
• Get an understanding as to why the Center for
  Substance Abuse Treatment has acknowledge Opioid
  Treatment as the most effective approach to
  treating individuals addicted to heroin and pain
  medication.

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Outline
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Out of the publics demand for quality Methadone
Maintenance Treatment (MMT), the federal
government conducted a pilot organization
development project in the late 1990s. On
January 17, 2001 CSAT published the final rule
for the accreditation of the revised named Opioid
Treatment Program (OTP). CSAT
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• Providers of treatment for Opioid Dependency have
  entered a new era of accountability, as Federal
  and State regulators increasingly demand
  objective evidence of treatment effectiveness.
  Since the length of treatment is associated with
  success of treatment, Opioid Treatment programs
  that demonstrate an ability to retain patients
  can make a strong case that they are effective.
• T. Ron Jackson, M.S.W.

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Definition of Terms
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Historical Overview

• May 18, 2001 Landmark Day for Methadone
  Maintenance
• Shift of Federal Oversight
• Programs Accountability and Licenses

• Program Flexibility
• SAMHSA coins the term Opioid Treatment Programs

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Program Related Factors for Change

• Methadone Dose
• Individualized Treatment Plans
• Contingency Contracting
• Counselors Behavior
• Staffs Acceptance of Philosophy

• Frequency of Counseling Contacts
• Clinical Directors Responsibilities
• Clinical Supervisors Responsibilities

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Proven Research Objectives

• Acquiring research information
• Identifying cost-effective research-based
  interventions

• Securing high-quality social services.
• Tracking retention rates.

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Recommendations for Managers

• Embrace change
• Focus on data
• Partner with researchers

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Fundamental Components
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Administrative Functions

• Business Practices
• Input from Stakeholders
• Assurance of Accessibility
• Information Management
• Rights of Persons Served
• Health and Safety
• Human Resources
• Leadership
• Legal Requirements
• Financial Planning and Management
• Governance

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Management Functions

• Attitude of staff and interaction with patients
• Ensure the development of a stable group of
  competent personnel
• Ensure staffs ability to handle transference and
  counter-transference
• Ensure staffs sensitivity to cultural, gender
  and age issues
• Ensure multicultural and multilingual
  representation
• Ensure performance evaluations of staff members
• Ensure retention of staff
• Ensure training for all staff
• Ensure measures for medication diversion
• Make provisions for grievance complaints
• Ensure good community relations
• Ensure the development of good program
  development and performance improvement
  procedures.

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Medical Functions

• Document that treatment is medically necessary.
• Provide comprehensive physical examination and
  laboratory workup as indicated.
• Evaluate the possibility of infectious disease,
  pulmonary cardiac abnormalities, dermatologic
  sequelae of addiction and possible concurrent
  surgical and other problems.
• Conduct an initial toxicology test as part of the
  admission process.
• Women of child-bearing age should receive a
  pregnancy test.
• Must have guidelines for medically supervised
  withdrawal, when indicated.

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Medical Functions Continues

• Make careful diagnostic distinctions between
  physical dependency and the disease of opioid
  addiction.
• Recommended to provide basic primary care onsite.
• Determine the individuals dose of medication.
• Documentation of all incident reports.

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Frequently Asked Questions and Medications Used
in Opioid Treatment
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What medications are currently approved by the
FDA for the treatment of Opioid Dependence?

• Methadone available as a generic drug and as a
  branded product under the names Methadose and
  Dolophine.
• Naltrexon Oral naltrexon to treat opioid
  dependence is available as both a generic drug
  and as a branded drug under the names of Revia
  and Depade
• Naltrexon Injectable naltrexone branded as
  Vivitrol is available to treat alcohol dependence
• Buprenorphine is only available as a branded
  drug under the names Suboxone and Subutex.

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How effective are Methadone and Buprenorphine in
the treatment of Opioid Dependence?

• Research has shown that both medications are
  effective for treatment of Opioid Dependence when
  combined with counseling and other psycho-social
  supports.
• Under current regulations, female patients who
  are pregnant generally receive methadone in
  Opioid Treatment programs. Although
  buprenorphine is not approved to treat this
  population, it can be prescribed if the physician
  believes the benefits outweigh the risks. NIDA
  is currently funding a study to compare the two
  medications for treatment of Opioid Dependent
  pregnant women.

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• Patients in rural areas, without ready access to
  transportation, or those who have employment or
  child care responsibilities may prefer treatment
  with buprenorphine because it can be prescribed
  in a local physicians office and obtained in
  local pharmacies.

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Is using methadone and buprenorphine to treat
Opioid Dependence simply replacing one addiction
with another?

• No, buprenorphine and methadone are not heroin
  substitutes, nor is naltrexone.
• Their pharmacologic effects differ substantially
  to those of heroin.
• Buprenorphine and methadone reduce cravings and
  prevent withdrawal, making the person more
  amenable to receiving related help for his or her
  addiction.

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• Buprenorphine and methadone are pharmacologically
  different from one another, although both are
  long acting medications and recognized by the FDA
  and NIDA as effective medications to treat Opioid
  Dependence when combined with appropriate
  counseling and psycho-social treatment.
• Methadone for treatment of Opioid Dependence is
  available only in Federally regulated and
  certified programs approved by the Center for
  Substance Abuse Treatment.
• Buprenorphine can be prescribed only by
  physicians who complete appropriate training and
  receive a waiver from the Center for Substance
  Abuse Treatment and DEA X number from the DEA.

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What is the function of both medications?

• Both are agonist that binds to a specific
  receptor in the brain and triggers a brain cell
  response.
• The agonist mimics the action of another
  substance such as heroin that binds to the same
  receptor.
• A full agonist has an affinity for and binds with
  a receptor to activate it, displacing the other
  medication at the receptor.
• Methadone is a full agonist that acts on the
  brains opoid receptors to fill those receptors
  and block the effects of other opioids.

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• Buprenorphine is a partial agonist. It also
  binds with and activates a given receptor, but is
  only partially effective at the receptor.
  Partial agonist limit the potential for overdose,
  increasing their safety and may make withdrawal
  from opiates easier for patients.
• An antagonist is a drug that blocks opioids from
  acting on the brain. Naltrexone, an opioid
  receptor antagonist, is used to treatment both
  opioid and alcohol dependence. Because
  naltrexone temporarily blocks the effects of
  opioids but does not affect craving, its use to
  treat Opioid Dependence is limited.
  Buprenorphine also has some antagonist actions in
  the brain.

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Should Opioid Dependent women who are pregnant
use methadone and buprenorphine?

• Pregnant women who use opiates are at increased
  risk of developing complications of pregnancy.
• A cold turkey withdrawal from opiates carries
  particular risks, including miscarriage.
• Opioid Treatment helps stabilize drug use and
  lifestyle, reduces or eliminates illicit use of
  opiates and can helps stabilize the in utero
  environment, facilitates access to comprehensive
  prenatal and antenatal care.

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• Pregnant women involved in Opioid Treatment
  programs have been reported to have significantly
  improved prenatal care leading to significantly
  reduced incidences of obstetric and fetal
  complications and neonatal morbidity and
  mortality, compared to women who use illicit
  drugs.
• Because there is more experience with methadone
  than with buprenorphine in pregnant women, many
  clinicians consider methadone to be the preferred
  medication to treat pregnant women who are
  addicted to opiates.

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• Evidence of the safety of buprenorphine during
  pregnancy is limited, and a number of adverse
  events have been reported. In particular, the
  buprenorphine-naloxone combination drug
  (Suboxone) should not be used in pregnant women
  because naloxone may have potential adverse
  affects on the fetus.

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Are babies born to mothers who are in Oopioid
Ttreatment born addicted to opiates?

• The babies may be physically dependent and
  experience withdrawal after birth. However, the
  intensity of their withdrawal syndrome does not
  always correlate with the maternal dose or the
  duration of maternal exposure.
• The withdrawal syndrome of the infant should be
  carefully managed by experienced medical experts.
  Available evidence indicates that the benefits
  of methadone maintenance for both the mother and
  infant outweigh any risks from the infants
  withdrawal syndrome.

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Should mothers who are undergoing opioid
treatment breastfeed their babies?

• Breastfeeding is not advised for mothers who are
  being treated with buprenorphine.
• Methadone is secreted into human milk and has
  been detected in very low plasma concentrations
  in some infants whose mothers were taking it.
  Caution should be exercised when methadone is
  administered to a nursing mother.
• Women who choose to breastfeed their infants
  while on methadone should be taught to identify
  any adverse effects in their babies and counseled
  that use of illicit drugs can increase the risk
  of her breastfeeding infant beyond any risk from
  methadone.

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Is medication-assisted treatment for Opioid
Dependence appropriate for adolescents under age
18?

• The safety and effectiveness of methadone has not
  been established in patients younger than age 18.
  
• For patient who are over age 15 but younger than
  age 18, buprenorphine is the preferred medication
  for treatment of Opioid Dependence.
• Parental consent may be an important issue for
  treatment of adolescent patients rules vary from
  state to state.

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Should patient with HIV participate in opioid
treatment for Opioid Dependency?

• Both methadone and buprenorphine interact with
  medications used to treat HIV. Medications must
  be carefully monitored.
• Higher doses may be necessary for some of these
  patients.
• Opioid Treatment of patients to opiates who also
  have HIV is particularly important both because
  participation in the treatment of addiction may
  foster adherence to HIV treatment and because
  treatment of the addiction has been shown to
  reduce the spread of HIV

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Should patients with Hepatitis C participate in
Opioid Treatment?

• Many patients who are addicted to opiates have
  been exposed to hepatitis C and are infected.
• This is not a contra-indication for treatment of
  their Opioid Dependency, nor is Opioid Dependency
  a contra-indication for treatment of hepatitis C
  and other infectious diseases. Treatment for
  addiction can serve as an avenue for education
  about and treatment of hepatitis C and other
  infectious diseases.
• Both buprenorphine and methadone are appropriate
  medications for this population.

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Methadone and Death

• Overdoses, poisoning and deaths that involve (but
  are not necessarily due to) methadone and other
  prescribed narcotics such as the painkiller
  oxycodone have increased nationally and have been
  described as increases of almost epidemic
  proportions, when all opioid analgesics are
  considered.
• Deaths must be understood in the context of the
  surging deaths from all prescribed opiates.
• Deaths from opiates have increased as sales have
  escalated, largely due to their increasing use in
  pain management.

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• Many health professionals, patients, and members
  of the public do not understand the dangers of
  using methadone in ways that do not conform to
  evidence-based guidelines (SAMHSA, 2007).
• Methadone can be toxic or lethal to those who
  have not developed adequate tolerance to it.
  This is especially true when taking it
  inappropriately, during the early stages of
  methadone treatment, and mixing it with
  prescribed or abused sedative or other drugs .
• Most of the increasing methadone overdose deaths
  being reported, do not involve patients who are
  undergoing treatment in approved Opioid Treatment
  clinics.

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• People who abuse methadone and other drugs, or
  those who are beginning or continuing Opioid
  Treatment, may have serious or fatal health
  problems, including cardiovascular or liver
  diseases or dependence on multiple drugs that
  interact with Opioid Dependence and abuse. These
  conditions may predispose both abusers and those
  in opioid treatment to illnesses, early mortality
  and vulnerability to overdose.
• Research clearly shows that far more narcotic
  overdose deaths occur due to prescribed or
  diverted opiates or involve those who abuse
  multiple substances than occur among those who
  take methadone in the course of treatment.

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• A small number of opioid treatment patients in
  legitimate treatment programs do overdose and
  die. Fatal overdoses among Opioid Treatment
  patients typically are complicated by or due to
  health problems or involved in multiple drug use.
• Deaths and overdoses from all narcotics including
  methadone and buprenorphine, among other
  prescribed opiate medications will continue to
  occur and increase because they are more often
  being prescribed or diverted, and they are
  powerful and dangerous chemicals when not
  administered properly.
• Overdose from and deaths from methadone are far
  fewer than those from unregulated, illegal use of
  heroin and pain medications.

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Counseling Functions

• Provide support and guidance to patients
• Monitor other problematic barriers.
• Help patients comply with OTP rules
• Identify problems that need extended services.
• Identify and remove barriers to full treatment
  participation.
• Provide motivational enhancement for positive
  changes in lifestyle.

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Scheduling
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OPT Matrix 7 Phases of Treatment
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Acute Phase

• Alcohol and drug use.
• Medical concerns.
• Co-occurring disorders.
• Basic Living concerns.
• Therapeutic relationships.
• Motivation and readiness for change.

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Rehabilitative Phase

• Alcohol and drug use.
• Medical concerns.
• Co-occurring disorders.
• Vocational and educational needs.
• Family issues.
• Legal problems.

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Supportive-Care Phase

• Alcohol and drug use.
• Medical and mental health concerns.
• Vocational and educational needs.
• Family issues.
• Legal issues.

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Medical Maintenance Phase

• Alcohol and drug use.
• Medical and mental health concerns.
• Vocational and educational needs.
• Family issues.
• Legal issues.

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Tapering Phase

• Alcohol and drug use.
• Medical and mental health concerns.
• Vocational and educational needs.
• Family issues.
• Legal issues.

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Readmission

• The consensus panel emphasizes that patients
  almost always should be encouraged to remain in
  treatment at some level and that pharmacotherapy
  should be reinstituted unreservedly for most
  previously discharged patients if and when
  relapse occurs or seems likely. Feelings of
  shame, disappointment, and relapse-related guilt,
  especially for rehabilitated patients who have
  close relationships with staff members, should
  not be allowed to inhibit patients from seeking
  reentry to treatment. The consensus panel
  recommends that all patients be informed at entry
  to the OTP that subsequent reentry is common and
  can be accomplished more quickly than initial
  intake because regulations waive documentation of
  past addiction for returning patients (42 CFR,
  Part 8 12(e)(3)). All obstacles to reentry
  should be minimized.

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Myths about Methadone

• Methadone will get you high.
• Methadone will make you sick.
• Long-term use of methadone damages the liver, the
  thyroid gland and the memory.
• Methadone rots your teeth and bones.
• Methadone makes you gain weight.
• Its easy to get off methadone/Its hard to get
  off methadone.
• People on methadone are still addicts, even if
  they dont use any other drugs.
• Methadone is a cure for Opioid Dependency.

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Practical Exercises
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Patient Retention

• Patient characteristics, behavior, and other
  factors unrelated to treatment have been found to
  contribute relatively little to retention.
• One comprehensive study found that retention was
  determined almost entirely by what happened
  during treatment, not before.

• In other studies, how patients entered treatment,
  whether voluntarily or by a court referral, did
  not affect treatment retention.
• Rhoades and colleagues (1998) reported that
  patients who previously received methadone were
  more likely to remain in treatment than
  first-time patients.

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Steps to Improve Patient Retention

• Individualized medication dosages.
• Clarifying program goals and treatment plan.
• Simplify the entry process.
• Reduce the attendance burden.
• Provide useful treatment services as early as
  possible.
• Improve staff knowledge and attitudes about
  treatment.

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References

• Brody, Ralph (2000). Effectively managing human
  service organizations. 2nd ed.
• Center for Substance Abuse Treatment (2006) CSAT
  guidelines for the accreditation of opioid
  treatment programs.
• Commission on Accreditation of Rehabilitation
  Facilities (2008). Opioid treatment program
  standards manual July 2009 June 2010.
• Gever, Matthew, NCSL (2009). Marc 2009
  Newsletter. Medication assisted treatment of
  opiate addiction.
• Gever, Matthew, NCSL (2009). January 2009
  Newsletter. Medication assisted treatment of
  opiate addiction.

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• Jackson T. Ron (2002). Treatment practice and
  research issues in improving opioid treatment
  outcomes.
• U.S. Department of Health and Human Services,
  SAMHSA, CSAT (2005), Medication-assisted-treatment
  for opoid addiction in opioid treatment
  programs, TIP 43.
• U.S. Department of Health and Human Services,
  SAMHSA, CSAT (2006). Substance abuse
  Administrative issues in outpatient treatment,
  TIP 46.