Richard Elovich, MPH Columbia University Mailman School of Public Health Medical Sociologist

1. Oral Substitution Treatment for Opioid Dependence: A Training in Best Practices & Program Design for Nepal Day 2 March 26-28, 2006 Kathmandu, Nepal UNDP Richard Elovich, MPH Columbia University Mailman School of Public Health Medical Sociologist Consultant, International Harm Reduction Development International Open Society Institute

2. This Training is Adapted From: • Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs CSAT/SAMSHA (Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment) • Best Practices in Methadone Maintenance Treatment Office of Canada’s Drug Strategy • Addiction Treatment: A Strengths Perspective Katherine van Wormer and Diane Rae Davis • Additional 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,

3. Clear Program Philosophy and Treatment Goals Adequate Resources Involvement Of Wider Community Program Development And Design Focus on Engagement and Retention Client/Patient Involvement A Maintenance Orientation Integrated Comprehensive Services A Client/Patient Centered Approach Accessibility

4. Training Goals • Ideally, 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 Kathmandu • Improved treatment outcomes

5. The Socio-Pharmacology of Opioid Use and Dependence Introduction and background of oral substitution treatment The pharmacology of medications used in oral substitution treatment Information collection and service provision: ‘assessment-in-action’ Pharmacotherapy and OST Insights from the field Six Training Modules

6. Learning Together Parallel Process

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

8. This 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 what’s coming up inside you in relation to what’s 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. Expectations for Certification: Training Contract

9. Try 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. Don’t 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. Learning Environment

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

11. What is Buprenorphine? • Antagonist / High receptor affinity • Highest receptor affinity and receptor occupancy: 95% occupancy at 16 mg (Greenwald et al, 2003) • Blockade or attenuate effect of other opioids • Rapid onset of action and risk of acute opioid reversal • Partial receptor agonist / Low Intrinsic Activity • Lower physical dependence • Limited development of tolerance • Ceiling effect on respiratory depression • Long Acting / Slow dissociation from receptor • Long duration of action • Milder withdrawal

12. Buprenorphine • A 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 buprenorphine’s 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)

13. Buprenorphine • As 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.

14. Buprenorphine • Another 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)

15. Buprenorphine • Buprenorphine 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)

19. Suboxone • A form of buprenorphine formulated with naloxone as a sublingual tablet • (Subutex or) Suboxone is absorbed sublingually • Naloxone is minimally absorbed and not biologically available • If the tablet is dissolved and injected the user will experience acute withdrawal

22. Melinda Campopiano, M.D. : My Protocol for Buprenorphine • Initial history and physical • 40 minutes • Follow-up phone call in 24 hours • Follow-up visit in one week • Usually 20 minutes • Monthly evaluation for refill/follow-up and preventive health care • 15 minutes

23. A. Monthly Evaluation for Refill and Brief Therapeutic Interventions • Motivational interviewing / Problem Solving Therapy • Relapse Prevention • Management of other medical problems • Health maintenance • Coordination of inpatient rehab care

24. Harm Reduction in Practice Meet them where they’re at • Work on what’s bothering them rather than what’s bothering me Have low threshold access • Same day and walk-in appointments If at first you don’t succeed, redefine success Dana Davis, Allegheny General Hospital Positive Health Center, Pittsburgh, PA

25. 3. Pharmacology of Medications Used to Treat Opioid Dependence • Pharmacology and Pharmacotherapy • Dosage Forms • Efficacy • Side Effects • Interactions with Other Therapeutic Medications • Safety

26. Dosage Forms • Diskettes/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.

27. Use less heroin Share fewer needles Less risky injection thus reducing risk of HIV and possibly Hepatitis C Increases tolerance to opioids thus reducing the risk of overdose De Castro S 2003, Sporer 2003 Reduction in need for risky financial activities and Needs less income from crime Have improved social interaction Reduced HIV seroconversion (2000 Drug Misuse Statistic Scotland) Improves compliance with medical therapy for other medical conditions Efficacy of Oral Substitution Treatment (OST)

28. 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 Outcome • What is functionality and fitness? • What is multiple outcomes? • What is exclusively abstinence?

29. MAINTENANCE TREATMENTWITH METHADONE TOLERANCE LEVEL DOSAGE LEVEL DURATION OF TREATMENT Robert G. Newman, MD The Baron Edmond de Rothschild Chemical Dependency Institute

30. Side Effects • Constipation, caused by slowed gastric motility • Sweating (similar with buprenorphine) • Other side effects can include: insomnia or early awakening, decreased libido or sexual performance (Hardman et al, 2001) • See handout

31. 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.

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

33. 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).

34. Client/Patient Treatment Education 2 • Other 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.

35. Client/Patient Treatment Education 3 • Maintaining 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.

36. IV. Information collection and service provision: ‘assessment-in-action’

37. Assessment in Action • A-in-A: No single moment, no single assessment instrument, no single staff person • Initial Screening • Admission Procedures and Initial Evaluation • Medical Assessment • Induction Assessment • Comprehensive Assessment

38. Initial Screening • The 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.

39. Initial Screening 2 • Staff 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 admission • What to expect during the admission process • Types of services offered

40. Goals of Initial Screening • Crisis 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.

41. Goals of Initial Screening 2 • Education. 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.

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

43. Admission Procedures and Initial Evaluation • Timely Admission, Waiting Lists, Referrals • Interim Maintenance Treatment • Denial of Admission • Admission Team • Information Collection and Dissemination

44. Timely Admission, Waiting Lists, Referrals • After 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.

45. Timely Admission • The 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.

46. Denial of Admission • Denial 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.

47. Admission Team • OST programs should have qualified, compassionate, well-trained, and multidisciplinary teams that efficiently collect applicant’s 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.

48. Adequate Human Resources Multidisciplinary Program Team Information Collecting & Sharing Team and Environment Competence, Attitudes, and Behaviors In Practice Safety Relationship Building and Support Flexible Routines Adequate Ongoing Training Program Environment

49. Program Team and Environment: Best Practices • Multidisciplinary Team Approach to Program Delivery • Adequate Human Resources • Competence, Attitudes and Behaviors in Practice • Relationship Building and Support • Adequate Ongoing Training • Program Environment • Organized Structured Approach to Treatment • Safety • Flexible Routines • Information Collection and Sharing

50. Admission Team 2 • Those 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.