*Oral Substitution Treatment for Opioid Dependence: A Training in Best Practices & Program Design for NepalRichard Elovich, MPHColumbia University Mailman School of Public Health Medical SociologistConsultant, International Harm Reduction Development International Open Society Institute

March 26-28, 2006 Kathmandu, NepalUNDPDay 2

*This Training is Adapted From:Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment ProgramsCSAT/SAMSHA (Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment)Best Practices in Methadone Maintenance TreatmentOffice of Canadas Drug Strategy Addiction Treatment: A Strengths PerspectiveKatherine van Wormer and Diane Rae DavisAdditional Sources: Robert Newman, MD, Alex Wodak, MD, Melinda Campopiano, M.D, Miller and Rollnick, Prochaska, DiClemente, and Norcross, Michael Smith, MD, Sharon Stancliff, MD, Ernest Drucker, PhD,

*Program DevelopmentAndDesignAccessibilityA MaintenanceOrientation

IntegratedComprehensiveServicesA Client/PatientCentered ApproachAdequateResourcesClear ProgramPhilosophy and Treatment GoalsInvolvementOfWiderCommunityClient/PatientInvolvementFocus on Engagement and Retention

*Training GoalsIdeally, this training will contribute to:Increased knowledge, skills and best practices among OST practitioners and providers;Engagement and retention of clients/patients in the OST program in KathmanduImproved treatment outcomes

*Six Training ModulesThe Socio-Pharmacology of Opioid Use and DependenceIntroduction and background of oral substitution treatmentThe pharmacology of medications used in oral substitution treatmentInformation collection and service provision: assessment-in-actionPharmacotherapy and OSTInsights from the field

*Learning TogetherParallel Process

*Learning Process: Knowledge and Skills Acquisition of content Retention (store in memory)Application (retrieve and use)Proficiency (integrate and synthesize)

*Expectations for Certification: Training ContractThis is an 18 hour training over a 3 day period. Allowances have been made for your work schedules: Noon 6 PM.You must be present and participate in all 18 hours of the training to receive certification. There can be no exceptions.Please stay focused. Be on task because we have a lot of material to cover in 3 days.Listening is a key to this training. Listen to new ideas. Listen to whats coming up inside you in relation to whats being presented. Try to put your thoughts and feelings into words instead of shutting down.Acknowledge and respect differences. You can agree to disagree on a contentious point and move on. Participate in role plays. Everyone has permission to pass. Offer feedback constructively not personally. Try to receive feedback as a gift.

*Learning EnvironmentTry to be okay with taking some learning risks. Stretch past your edge of what you know and what you are comfortable with.Confidentiality. Hold the container. Dont be leaky.Turn off phones please.No cross talk. Allow one person to speak at a time. Equal time over time. Start and end on time, including breaks. Be alert to tendency to fudge this.Use I statements.Can everybody agree to this training contract? Is there anything you absolutely cannot live with?Now we are off.

*III. The pharmacology of medications used in oral substitution treatment

*What is Buprenorphine?Antagonist / High receptor affinityHighest receptor affinity and receptor occupancy: 95% occupancy at 16 mg (Greenwald et al, 2003)Blockade or attenuate effect of other opioidsRapid onset of action and risk of acute opioid reversalPartial receptor agonist / Low Intrinsic Activity Lower physical dependenceLimited development of toleranceCeiling effect on respiratory depressionLong Acting / Slow dissociation from receptorLong duration of actionMilder withdrawal

*BuprenorphineA derivative of the opiate alkaloid thebaine, is a synthetic opioid and generally is described as a partial agonist at the mu opiate receptor.Research has demonstrated that buprenorphines partial agonist effects at mu receptors, its unusually high affinity for these receptors, and its slow dissociation from them are principal determinants of its pharmacological profile (Cowan 2003)

*BuprenorphineAs a partial mu agonist, buprenorphine, does not activate mu receptors fully (i.e., it has low intrinsic activity) resulting in a ceiling effect that prevents larger doses of buprenorphine from producing greater agonist effects. (Walsh et al. 1994)As a result there is greater margin of safety from death when increased doses are used, compared with increased doses of full opiate agonists.

*BuprenorphineAnother feature of buprenorphine is that it can be used on a daily or less than daily basis, alternate day, thrice weekly, because, although larger doses do not increase its agonist activity, they do lengthen its duration of action (Chawarski et al. 1999)

*BuprenorphineBuprenorphine overdose is uncommon. When instances were reported in France, they were almost always associated with uptake of high doses of benzodiazepines, alcohol, or other sedative type substances (Klintz 2001, 2002)

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*SuboxoneA form of buprenorphine formulated with naloxone as a sublingual tablet(Subutex or) Suboxone is absorbed sublinguallyNaloxone is minimally absorbed and not biologically availableIf the tablet is dissolved and injected the user will experience acute withdrawal

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*Melinda Campopiano, M.D. : My Protocol for BuprenorphineInitial history and physical 40 minutes Follow-up phone call in 24 hoursFollow-up visit in one weekUsually 20 minutesMonthly evaluation for refill/follow-up and preventive health care15 minutes

*A. Monthly Evaluation for Refill and Brief Therapeutic InterventionsMotivational interviewing / Problem Solving TherapyRelapse PreventionManagement of other medical problemsHealth maintenanceCoordination of inpatient rehab care

*Harm Reduction in PracticeMeet them where theyre atWork on whats bothering them rather than whats bothering meHave low threshold accessSame day and walk-in appointmentsIf at first you dont succeed, redefine success

Dana Davis, Allegheny General Hospital Positive Health Center, Pittsburgh, PA

*3. Pharmacology of Medications Used to Treat Opioid DependencePharmacology and PharmacotherapyDosage FormsEfficacySide EffectsInteractions with Other Therapeutic MedicationsSafety

*Dosage FormsDiskettes/tablets, oral solutions, liquid concentrate, and powder. Currently in the U.S. methadone is usually administered in liquid form. Other forms are available on the basis of clinic and patient preference.Advantages to the diskette form (scored tablets, dissolved in water, taken orally with flavored liquid) are easy inventory, and the ability for patients to see what they are taking before liquid is added.

*Efficacy of Oral Substitution Treatment (OST)Use less heroin Share fewer needlesLess risky injection thus reducing risk of HIV and possibly Hepatitis CIncreases tolerance to opioids thus reducing the risk of overdoseDe Castro S 2003, Sporer 2003Reduction in need for risky financial activities and Needs less income from crime Have improved social interactionReduced HIV seroconversion (2000 Drug Misuse Statistic Scotland)Improves compliance with medical therapy for other medical conditions

*Multiple Outcomes vs. Single or Exclusive Outcome Functioning, fitness and Multiple Outcomes are Perceived as a Challenge to Dominant Treatment Models Where Abstinence is the Exclusive OutcomeWhat is functionality and fitness?What is multiple outcomes?What is exclusively abstinence?

*Robert G. Newman, MDThe Baron Edmond de Rothschild Chemical Dependency Institute DURATION OF TREATMENTMAINTENANCE TREATMENT WITH METHADONE DOSAGE LEVELTOLERANCE LEVEL

*Side EffectsConstipation, caused by slowed gastric motilitySweating (similar with buprenorphine)Other side effects can include: insomnia or early awakening, decreased libido or sexual performance (Hardman et al, 2001)See handout

*Interactions with other Medications (Hand out 34-42)Because methadone (as well as buprenorphine) is metabolized chiefly by the CYP3A4 enzyme system (a part of the CYP450 system), drugs that inhibit or induce the CYP450 can alter the pharmacokinetic properties of these medications.Drugs that inhibit or induce this system can cause clinically significant increases or decreases, respectively, in serum and tissue levels of opioid medications.

*SafetyEducating client/patients about the risks of drug interaction is essential. The following information should be emphasized: (Next 3 Slides)

*Client/Patient Treatment Education During any agonist-based pharmacotherapy, using drugs or medications that are respiratory depressants (e.g., alcohol, other opioid agonists, benzodiazepines) may be fatal.Current or potential cardiovascular risk factors may be aggravated by opioid agonist pharmacotherapy, but certain treatment strategies reduce cardiovascular risk (and should be included as needed in patients treatment plans).

*Client/Patient Treatment Education 2Other drugs illicit, prescribed, or over the counter have potential to interact with opioid agonist medications (specific, relevant information should be provided).Patients should know the symptoms of arrhythmia, such as palpitations, dizziness, lightheadedness, or seizures, and should seek immediate medical attention when they occur.

*Client/Patient Treatment Education 3Maintaining and not exceeding dosage schedules, amounts, and other medication regimens are important to avoid adverse drug interactions.When opioid medication dosage must be adjusted to compensate for the effects of interacting drugs, patients should be observed for signs or symptoms of opioid withdrawal or sedation to determine whether they are under medicated or overmedicated.

*IV. Information collection and service provision: assessment-in-action

*Assessment in ActionA-in-A: No single moment, no single assessment instrument, no single staff personInitial Screening Admission Procedures and Initial EvaluationMedical AssessmentInduction AssessmentComprehensive Assessment

*Initial ScreeningThe screening process begins when individual or relative first contacts OST.This contact, even by telephone, is the first opportunity for treatment providers to establish an effective therapeutic alliance among staff members, client/patients, and their families.Content is the information provided, what actually happens during the contact. Process is how the client/patient experiences the contact.

*Initial Screening 2Staff members should be prepared to provide immediate, practical information that helps potential client/patients make decisions about OST, including:The approximate length of time from first contact to admissionWhat to expect during the admission processTypes of services offered

*Goals of Initial ScreeningCrisis intervention. Identification of and immediate assistance with crisis and emergency situations.Eligibility verification. Assurance that a potential client/patient satisfies program criteria for admission to an OST program.Clarification of the treatment alliance. Explanation of patient and program/staff expectations and responsibilities.

*Goals of Initial Screening 2Education. Communication of essential information about OST operation and procedures: dosing schedules, OST hours, treatment requirements, key/lock analogy and explanation of agonist therapy. Discussion of the benefits and drawbacks (costs) of OST to help potential client/patients make informed decisions about this mode of drug treatment.

*Goals of Initial Screening 3Identification of treatment barriers. Determination, through open-ended questions and reflective listening of factors that might hinder a potential client/patients ability to meet treatment requirements, for example, lack of childcare or transportation, commitments and schedule at work.

*Admission Procedures and Initial EvaluationTimely Admission, Waiting Lists, ReferralsInterim Maintenance TreatmentDenial of AdmissionAdmission TeamInformation Collection and Dissemination

*Timely Admission, Waiting Lists, ReferralsAfter initial screening, the admission process should be thorough and facilitate timely enrollment in the OST program. This process is characterized by the client/patients first exposure to the treatment system: its personnel, including ombudsman, other patients, available services, expectations (rules and requirements).The Admission process should be designed to engage new client/patients positively and empathically.

*Timely AdmissionThe longer the delays between first contact, initial screening, and admission and the more appointments required to complete these procedures, the fewer potential client/patients enter treatment.Prompt, efficient orientation and evaluation, along with accurate empathy, contribute to the therapeutic nature of the admission process.

*Denial of AdmissionDenial of admission to an OST should be based on sound clinical practices and the best interests of the drug user and the OST program.Admission denial might be considered if the individual is threatening or violent.Due process and attention to drug users rights minimize the possibility that decisions to deny admission to OST are abusive, arbitrary or discriminatory.

*Admission TeamOST programs should have qualified, compassionate, well-trained, and multidisciplinary teams that efficiently collect applicants information and histories, evaluate their needs as client/patients.Team members should be cross-trained in treating dependence and co-occurring problems and disorders.Team members should be able to communicate about OST program services, policies and procedures, as well as make appropriate referrals.

*Team andEnvironmentProgramEnvironmentRelationshipBuilding andSupport

FlexibleRoutines AdequateOngoingTrainingMultidisciplinaryProgramTeamAdequateHumanResourcesInformationCollecting &SharingSafetyCompetence,Attitudes, and BehaviorsIn Practice

*Program Team and Environment: Best PracticesMultidisciplinary Team Approach to Program DeliveryAdequate Human ResourcesCompetence, Attitudes and Behaviors in PracticeRelationship Building and SupportAdequate Ongoing TrainingProgram EnvironmentOrganized Structured Approach to TreatmentSafetyFlexible RoutinesInformation Collection and Sharing

*Admission Team 2Those conducting admission interviews should employ MI techniques, including accurate empathy, and their interactions with applicants should not be stigmatizing, and should avoid a vertical or expert character to the therapeutic alliance. Interview style should be respectful and encourage trust, so that rapport is established and client/patient can speak honestly and realistically about his/her experience of drug use, dependence, personal matters and co-occurring psychological and social problems.

*Barriers to Engagement and Retention of Clients/PatientsAttitudinal barriers to treatment including fear and misinformationPhilosophical differences among practitioners within programInsufficient resources for treatmentLack of trained practitioners with experience working with opioid usersOver regulation of programs by government or fundersUneven or fragmented access to service across sectors or provincesLack of access in rural or remote areasLack of effective outreachProgram policies (admission criteria, dosing levels, etc.)Lack of supports for clients/patients (costs of treatment, access to and cost of transportation, access to and cost of child care, etc.)Lack of supports for team members resulting in burn out, poor attitudes, frequent turn-over of staff, etc.

*Progress to Overcoming BarriersA growing awareness in the field that ongoing dialogue at all levels as well as a commitment to collaboration and coordination will be needed to overcome barriers and increase access to OST in NepalAn increased recognition among practitioners of the need for flexible and individualized services, driven by client/patient needsAn increased recognition among medical practitioners that social workers and outreach workers are key to effective program delivery

*Progress to Overcoming BarriersAn increasing emphasis in the field on the role of methadone maintenance treatment programs within a harm reduction approach to opioid dependenceInternational recognition of methadone maintenance treatment particularly low threshold approaches as an important strategy to combat transmission of HIV and to help prevent and control the transmission of HCV and other blood borne pathogens among drug users and their relatives.International recognition of methadone maintenance treatment as an excellent site for HIV treatment services

*Presentation of the Program to Potential Clients/PatientsOST programs should:Respect and protect the dignity of clients/patientsEmpower clients/patientsBe no mixed messages e.g. all members of the program should ascribe to a maintenance orientation and sing off the same pageClients/patients should be able to be honest about their reasons for entering, staying in or leaving OST rather than having to give the right answers in order to comply with arbitrary program requirements or appear as a good patient in order to get staff approval.

*What does the Philosophy of the Program Mean?Programs should examine and clarify their underlying assumptions about drug use, about the people who use drugs, about opioid dependence, about people who are opioid dependent, and about the goals of treatment.The specific policies and procedures of the program should be consistent with the overall philosophy.The program policies, procedures, and philosophy should be made clear to all members of the program team and to clients/patients.

*A Maintenance OrientationMethadone maintenance programs or OST more broadly should focus on reducing HIV and other harms associated with injection opioid use by retaining clients/patients in treatment.The evidence indicates that a long-term maintenance philosophy increases retention in treatment, even though the individual client/patient will determine their duration in treatment, their goals for treatment, and their own pace of change related to the goals.

*Focus on Engagement and RetentionEngagement in OST is critical when the small window of opportunity appears, the moment of client/patient interest, programs should seize the moment and focus on engaging people who are dependent on opioids in treatment in as short a period of time as possible (SAMSHA 2005)

*Retention in Treatment is EssentialIf clients/patients dont remain in treatment, they have little opportunity to achieve any potential gains from OST (see slide 24, day 2).Retention is also important over the long-term, given that length of time in treatment has been affirmed repeatedly by researchers as positively associated with achieving good treatment outcomes, including achieving other positive outcomes and benefits of OST.

*What is a Client/Patient-Centered Approach?AccessibilityOutreach and proactive (rather than passive) recruitment of clients/patientsRecognition and acknowledgement that opioid dependent individuals have practice knowledge, competencies, strategies, and interest in program transparency based in their experience and street expertise with opioid use Recognition and acceptance that each client/patient has widely varying life and drug experiences, expectations, strengths, capacities, and needsRecognition of the impact of marginalization and stigmatization and emphasizing individual and collective empowermentRespect for client/patients dignityRespect for clients/patients choices, particularly concerning their expectations and their treatment goalsEncouragement and facilitation of client/patient involvement in decision-making at the individual and program levelsFostering a collaborative, relationship-building approach between clients/patients and program team members

*The Admission and Assessment ProcessClient/patients entering treatment may be in crisis and/or feeling very ill the admission and assessment process should be as sensitive and timely as possible an overly extensive assessment can produce fatigue and frustration and encourage clients/patients to try to say the right thing to get through it.

*Information Collection and DisseminationTreatment history: including previous episodes of treatment including dates and durations; patterns of use of treatment; perspectives on successes and failures; what was helpful and not so helpful; written consent should be provided by client/patient before contacting another treatment provider Orientation to OST: extending over several sessions, a transparent explanation of treatment methods, options, and requirements and the roles and responsibilities of those involved; client rights, confidentiality, and access to information should be discussed and documented. If possible, a new client/patient should receive a handbook or written materials on all relevant program specific information to comply with treatment requirements and to fully understand treatment options.

*Information Collection and DisseminationTreatment history: including previous episodes of treatment including dates and durations; patterns of use of treatment; perspectives on successes and failures; what was helpful and not so helpful; written consent should be provided by client/patient before contacting another treatment provider Orientation to OST: extending over several sessions, a transparent explanation of treatment methods, options, and requirements and the roles and responsibilities of those involved; client rights, confidentiality, and access to information should be discussed and documented. If possible, a new client/patient should receive a handbook or written materials on all relevant program specific information to comply with treatment requirements and to fully understand treatment options.

*Information Collection and Dissemination 2Age of ApplicantRecovery environmentPatient personal recovery resourcesSuicide and other emergency risksSubstances of abusePrescription drug and over-the-counter medication useImpulse control and self-regulation

*Information Collection and Dissemination 3Method and level of opioid use: frequency, amounts, route of administration; client/patient reporting helps staff to assess dependence, tolerance levels, and providing a starting point to prescribe appropriate OST for stabilization (American Psychiatric Association, 2000).

*Information Collection and Dissemination 4Pattern of daily preoccupation with opioids: A client/patients daily pattern of opioid use and dependence should be determined. Regular and frequent use to offset withdrawal is a clear indicator of physiological dependence.People who are opioid dependent generally spend increasing amounts of time and energy obtaining, using, experiencing and responding to the effects of these drugs.

*Information Collection and Dissemination 5Patient motivation and reasons for seeking treatment: prospective client/patients typically present for treatment because they are in withdrawal and want relief. They often are preoccupied with whether and when they can receive medication. Because successful OST entails not only short-term relief but a steady, long-term commitment, client patients should be asked why they are seeking treatment, why they chose OST, and whether they fully understand all available treatment options, options related to OST, and the nature of OST. This inquiry is ongoing and not restricted to admission.

*Information Collection and Dissemination 6Scheduling the next appointment

*MethadoneMaintenanceHIV Prevention Health Promotion& EducationCounselingAndSupport

MentalHealthServicesMedical& HIVCareOther SubstanceTreatment ProgramsOutreachAndAdvocacyLinkagesWith NGO ServicesAnd SupportKey Components of a Comprehensive Approach

*Medical AssessmentEach client/patient should undergo a complete, fully documented physical examination (overall health status/functioning) by a physician before admission to the OST.However, key elements can be done during admission, while some aspects of examination can be conducted within first 14 days of admission. Women should receive a pregnancy test and a gynecological examination by an OBGYN at the OST or at a Womens Health Center.

*Barriers that Limit Womens Access to TreatmentInsufficient women focused outreachSocial stigmatization of women drug users, including by medical communityLack of gender specific treatment to address womens issues, i.e. lack of attention to psychosocial issues, relational and family issues, and exclusive focus on abstinence oriented counselingGender or cultural insensitivity in treatment programsFear of losing custody of their childrenIntimidation by relatives including mothers-in-law, husband, etc. Lack of child care or care for other dependent family members

What else can you think of?

*Insights from the FieldAt birth, infants should not be assumed to be dependent on opioids, but should be properly assessed.There needs to be continuity of care and close coordination between OST program and perinatal servicesPregnant women who are dependent on opioids should have priority access to OST, and access from multiple and low stigmatization entry points

*Insights from the FieldOST should directly or indirectly (NGO) provide women only group work and psychosocial counseling on a wide range of issues driven by the expressed needs of women drug usersOST should directly or indirectly (NGO) provide women with couples or family group work

*To Improve Treatment for WomenScreening for women-specific medical and psychological concernsAccess to safety planning and safe housingSupport and counseling to address abuse, including post-traumatic stress servicesCounseling by and for women (individual and group)Women specific programming in areas including:NutritionSmoking

Health, with particular attention and sensitivity to reproductive health issues, relational and control issues around injecting, issues related to sex workParentingAssertiveness trainingImproved self-esteemBuilding self-efficacy in relation to particular issuesHealthy relationshipsEmployment

*Potential Benefits of Women Supportive Services in OSTSafer, medically supervised uptake of opioidBetter perinatal careIncreased fetal growthReduced fetal and infant mortalityIncreased likelihood of carrying pregnancy to termGreater likelihood of women accessing services that are not exclusively crisis orientedFewer birth complicationsBetter outcomes among HIV positive women for opportunistic infectionsDecreased transmission of HIV, HCV, and other STIsDecreased cases of preeclampsia and neonatal abstinence syndromeIncreased retention in treatmentImproved family situations

*Medical Assessment 2Determination of opioid dependence and verification of admission eligibilityIn general, opioid pharmacotherapy is appropriate for persons who are currently dependent and became dependent at least 1 year before admission.Documentation of past dependence might include treatment records or a primary physicians oral or written report.When an applicants status is uncertain, admission decisions should be based on drug test results and consultation with the client/patient.

*Medical Assessment 3Exemptions from 1-year dependence duration guidelineClient/Patients released from correctional facilities (within 6 months of release)Pregnant client/patientsPreviously treated client/patientsA person under the age of 18, who has two documented attempts at detoxification, and is accompanied by a parent

*Medical Assessment 4Cases of UncertaintyAdministration of naloxone can result in severe withdrawal and is not recommended and can undermine development of positive therapeutic alliance; there are less invasive ways. Naloxone should be reserved to treat opioid overdose emergencies. Patient can be observed for the effects of withdrawal after he/she has not used an opioid for 6-8 hours.Administering a low dose of methadone and then observing the patient also is appropriate

*Medical Assessment 5Testing for hepatitis A, B, and C; syphilis, other sexually transmitted infections (STIs), and chlamydia and gonococcus infections; tuberculosis; hypertension; and diabetes. HIV infection should require a client/patients written informed consent, along with pre and post test counseling Liver and Kidney functions.

*Specific Risks for PLWHAs* The risks of morbidity that is specifically related to ID use (endocarditis, absesses and co-infection with HCV and other blood borne pathogens)The higher rates of bacterial pneumonia and tuberculosis and greater risk of mortality given compromised immune systemThe potential to develop drug-resistant strains of HIV, in the event of poor compliance with ARV meds.Potential for drug interactions

* People living with HIV and AIDS

*OST and PLWHAsProgram delivery should include testing for HCV infection. HCV is 10 to 15 times more infectious through blood contact than HIV (Health Canada 2000)Outreach is keyShould be priority access to OST for people dependent on opioids and LWHAShould engage clients/patients in OST through STD programs and low threshold and low stigma points of entry, i.e. NGOs engaged in harm reduction and other forms of drug treatment. If an individual drops out or is asked to leave an abstinence oriented treatment program, he or she should be referred to both NGO needle exchange and OST

*OST and PLWHAsProgram Delivery:Include testing for HIVInclude direct or indirect provision of primary care for HIVCombined treatment for opioid and HIV, given drug interactions, etc.Pain managementClient/patient education on harm and risk reduction, including overdoseAppropriate protocols concerning liaison with public health, notification, client/patient confidentiality

EducationSensitize people working in the area of HIV/AIDS to the needs of people receiving OST and people who are opioid dependentExpand current efforts to develop linkages and exchanges between people and NGOs working in HIV/AIDS, e.g. needle exchange programs, with providers of OST and health ministry agency dedicated to HIV/AIDS

*Acute, Life Threatening InfectionsEndocarditis, infection, usually bacterial, of the inner lining of the heart and its valves.Soft-tissue infections, such as abscesses and cellulitis, involve inflammation of skin and subcutaneous tissue, including muscle.

*Acute, Life Threatening Infections 2Necrotizing fasciitis, sometimes called flesh-eating infection, usually is caused by introduction of the bacterium Streptococcus pyogenes into subcutaneous tissue via a contaminated needle.Wound Botulism is caused by the neurotoxin of Clostridium botulinum, a bacterium usually found in contaminated food, but botulism poisoning has occurred among people who inject drugs

*Medical AssessmentThe results of medical assessment, including toxicology tests, other laboratory results, and psychosocial assessment, usually are reviewed by a program physician and then submitted to the medical director in preparation for pharmacotherapy.

*OST and Mental HealthResearch consistently documents that people with mental health disorders are at increased risk of drug use, including cigarettes, opioids, and other substances used for self-medicating.Identifying and providing treatment for mental health disorders can help improve OST outcomes, including retention, reduction of use of short-term opioids, self-regulation, functionality, and stabilization of living situation.

*OST Programs may be able to Provide:Access to mental health evaluations and treatment services, psychotherapy and counselingA stable environment and consistent mental structure (daily attendance, clear rules, structured social interaction, sensitivity to self-management issues)Dispensing of other medications along with methadone dosesAccess to medical careOpportunities to establish positive relationships with OST and health care providersInvolvement in volunteer activities and workInvolvement in psychosocial rehabilitation programs

*OST and Mental HealthStabilize clients/patients on methadone first, and then assess primary vs. secondary mental health disorders (Which comes first, the chicken or the egg?) In order to diagnose and treat independent mental health disorders, the presence of symptoms that stem from other medical conditions or from use of drugs should be ruled out. For example, use of some drugs may either cause symptoms which present as depression, or else interfere with the management of a mood disorder. To rule out substance induced disorders, a skilled assessment can take into account how symptoms respond to increases or decreases in drug use, or periods of abstinence.

*Co-morbid Mental Health DisordersMood disordersAnxiety disordersPersonality disorders (most common)Antisocial personality disorderBorderline personality disorderAvoidant disorderPassive-aggressive disorderParanoid disorderOther Mental Health DisordersSchizophreniaPosttraumatic stress disorderAttention deficit hyperactivity disorder

*OST and Mental HealthInvolve relatives and family support from the beginning of and throughout treatmentEnsure good and clear communication among all team members and linkage specialists or programs.

*Medical AssessmentPrograms should minimize delay in administering the first dose of medication because, in most cases, applicants will present in some degree of opioid withdrawal.

*Relationship Building and SupportRegardless of setting, program should offer a zone of tolerance for clients/patients often highly marginalized outsideThe quality of relationships will affect compliance, attitude, motivation of clients/patients. Therapeutically induced resistance.Team members view of their work will be enhanced by having positive relationships with clients/patients. Since relationships are a pivotal factor in how well treatment works, they should be a point of focus for measuring outcomes.It is essential for clients/patients to have a non-judgmental person, such as an ombudsman, to talk with.Physicians, nurses, social workers in the team need supports such as training, mentorship, supervision,etc.

*Information Collection and Dissemination 2Age of ApplicantRecovery environmentPatient personal recovery resourcesSuicide and other emergency risksSubstances of abusePrescription drug and over-the-counter medication useImpulse control and self-regulation

*Information Collection and Dissemination 3Method and level of opioid use: frequency, amounts, route of administration; client/patient reporting helps staff to assess dependence, tolerance levels, and providing a starting point to prescribe appropriate OST for stabilization (American Psychiatric Association, 2000).

*Information Collection and Dissemination 4Pattern of daily preoccupation with opioids: A client/patients daily pattern of opioid use and dependence should be determined. Regular and frequent use to offset withdrawal is a clear indicator of physiological dependence.People who are opioid dependent generally spend increasing amounts of time and energy obtaining, using, experiencing and responding to the effects of these drugs.

*Information Collection and Dissemination 5Patient motivation and reasons for seeking treatment: prospective client/patients typically present for treatment because they are in withdrawal and want relief. They often are preoccupied with whether and when they can receive medication. Because successful OST entails not only short-term relief but a steady, long-term commitment, client patients should be asked why they are seeking treatment, why they chose OST, and whether they fully understand all available treatment options, options related to OST, and the nature of OST. This inquiry is ongoing and not restricted to admission.

*Information Collection and Dissemination 6Scheduling the next appointment

*Ongoing Assessment: Best PracticesConsider client/patient goals and expectations for treatment, not just those of the programCreate resource rooms containing food and clothing items (see Maslow)Use a partnership approach some physicians administer Addiction Severity Index & the Opiate Treatment Index themselves, while others work with trained personnel, or partner with social workers experienced in drug dependenceBalance assessment (information gathering) with provision of information to clients/patients and responses to their questions (flexibility)Assessment may be seen as either intrusive some client/patients have been through many prior assessments or threatening, e.g., some client/patients fear consequences of their truthful answers

*V. Stages of Pharmacotherapy

*Stages of PharmacotherapyInductionStabilization and Dosage DeterminationMaintenanceStudies of the Importance of DosingTake-Home MedicationsMedically Supervised Withdrawal After Detoxification, Tapering, or Dosage Reduction

*InductionInduction procedures depend on the unique pharmacological properties of each OST type of medication, prevailing regulatory requirements, and patient characteristics and expectations.Regardless of the medication, safety is the key during the induction phase.

*Induction ConsiderationsTimingOther substance useDirectly observed therapy

*Initial DosingThe first dose of any opioid treatment medication should be lower if a patients opioid tolerance is believed to be low, the history of opioid use is uncertain, or no signs of opioid withdrawal are evident.Dosage adjustments in the first week of treatment should be based on how patients feel at the peak period for their medication (e.g., 2 to 4 hours after a dose of methadone is administered), not on how long the effects of a medication last. As stores of medication accumulate in body tissues, the effects begin to last longer.

*Steady StateInitial dosing should be followed by dosage increases over subsequent days until withdrawal symptoms are suppressed at the peak of action for the medication.Methadone and buprenorphine are stored in body tissues, including the liver, from which their slow release keeps blood levels of medication steady between doses.

*Steady State 2It is important for physicians, staff members, and client/patients to understand that doses of medication are eliminated more quickly from the bloodstream and medication effects wear off sooner than might be expected until sufficient levels are attained in the tissues.

*Steady State 3During induction, even without dosage increases, each successive dose adds to what is present already in tissues until steady state is reached. Steady state refers to the condition in which the level of medication in a client/patients blood remains fairly steady because that drugs rate of intake equals the rate of its breakdown and excretion.

*Steady State 4Steady state is based on multiples of the elimination half-life. Approximately 4-5 half-life times are needed to establish a steady state for most drugs. For example, because methadone has a half-life of 24-36 hours, its steady state the time at which a relatively constant blood level should remain present in the body is achieved in 5 to 7.5 days after dosage change for most patients. However, individuals may differ significantly in how long it takes to achieve steady state.

*Initial DosingFor a client/patient actively dependent on opioids, a typical first dose of methadone is 20 to 30 mg (Joseph et al. 2000).If withdrawal symptoms persist after 2 to 4 hours, the initial dose can be supplemented with another 5-10 mg. (Joseph et al. 2000) up to 40 mg.

*Variations in Individual Response and Optimal DosingMost differences in client/patient response to methadone can be explained by variations in individual rates of absorption, digestion, and excretion of the drug, which in turn are caused by such factors as body weight and size, other substance use, diet, co-occurring disorders and medical diseases, and genetic factors.

*Variations in Individual Response and Optimal Dosing 2Because variation in response to methadone is considerable, SAMSHA believes that the notion of a uniformly suitable dosage range or an upper dosage limit for all patients is unsupported scientifically.

*Variations in Individual Response and Optimal Dosing 3Whereas 60 mg of methadone per day may be adequate for some, it has been reported that some client/patients require much more for optimal effect.Treatment providers should avoid thinking of high dosage as being above a certain uniform threshold; however, there are few data on the safety of methadone doses above 120 mg/day.

*Variations in Individual Response and Optimal Dosing 4Looking for clinical signs and listening to client/patient reported symptoms related to daily doses or changes in dosage can lead to adjustments and more favorable outcomes (Leavitt et al. 2000).Generally, the disappearance of opioid withdrawal symptoms indicates adequate dosing and serum methadone levels (SMLs) within the therapeutic comfort zone.

*Maintenance Pharmacotherapy 5The goal of methadone maintenance treatment can be increased functionality, quality, and quantity of life rather than abstinence.Both individual and societal benefits are achieved in maintenance even if abstinence is not an outcome.

*Desired Responses to Optimal Dosage Determinations: Prevention of opioid withdrawal for 24 hrs. or longer, including both early subjective symptoms and objective signs typical of abstinence.Elimination of drug hunger or cravingBlockade of euphoric effects of self administered opioids (not a true block but reflects cross tolerance for other opioids, attenuating or eliminating desired sensations from self administered of street opioids.

Tolerance for the sedative effects of treatment medication, creating a state in which client/patients can function normally without impairment of perception or physical or emotional response.Tolerance for most analgesic effects produced by treatment medication

*The Importance of Adequate DosingStrong evidence supports the use of daily methadone doses in the range of 80mg or more for most patients (Strain et al. 1999), but considerably variability exists in patient responses. Some do well on dosages below 80 to 120 mg per day, and others require significantly higher dosages (Joseph et al. 2000).

*The Importance of Adequate Dosing 2Much evidence shows a positive correlation between medication dosage during OST and treatment response (e.g., Strain et al. 1999).Higher dosages in some studies appeared to produce greater cross tolerance.Cross tolerance occurs when medication diminishes or prevents the euphoric effects of heroin or other short-acting opioids, so that patients who continue use of street opioids no longer feel high.

*Adequate Dosing and Treatment RetentionAn Australian study connected the importance of dosage with patient retention in OST (Caplehorn and Bell, 1991).Benefits include eliminating short-term opioids, reductions in the threats of HIV and hepatitis B and C.

*Maintenance PharmacotherapyThe maintenance stage of opioid pharmacotherapy begins when a patient is responding optimally to medication treatment and routine dosage adjustments are no longer needed.Patients at this stage have stopped using short-term opioids and other substances and have turned now to improving functionality and stabilizing their lives.

*Maintenance Pharmacotherapy 2Client/patients in maintenance may turn away from the people, places, and things associated with their use of short-term opioids and dependence.Patients who continue to use short-term opioids or other illicit substances may benefit from intensified counseling and other services to help them achieve the maintenance stage.

*Maintenance Pharmacotherapy 3During the maintenance stage, many client/patients remain on the same dosage of treatment medication for many months, whereas others may need frequent or occasional adjustments.Periods of increased stress, serious emotional crises, physical problems, negative environmental factors, greater drug availability, pregnancy, or increased drug hunger can reawaken the need for increased dosage over short or extended periods.

*Maintenance Pharmacotherapy 4Although the counseling relationship and patient interview are paramount, drug test reports and medication blood levels are useful for dosage determination and adjustment during and after transition from stabilization to the maintenance stage.

*Maintenance Pharmacotherapy 5The goal of methadone maintenance treatment can be increased functionality, quality, and quantity of life rather than abstinence.Both individual and societal benefits are achieved in maintenance even if abstinence is not an outcome.

*Comprehensive ServicesAccording to research reviewed by NIDA* (1995) two of the program characteristics associated with treatment success are: providing comprehensive services and integrating medical, counseling, and administrative services.According to NIDA: At 24 weeks, methadone alone resulted in minimal improvements; methadone plus counseling resulted in significant improvements over methadone alone; and enhanced methadone services, including a broad range of psychosocial services plus methadone, had the best outcomes of all.

* National Institute for Drug Abuse, U.S. Government

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