1. Using Buprenorphine in Opioid Treatment Programs Allan J. Cohen MA, MFT Director of Research and Training Bay Area Addiction Research and Treatment, Inc. (BAART) American Association for the Treatment of Opioid Dependence Atlanta, GA April, 2006

2. Assumptions Many of you are treatment providers primarily Most have at least heard of bup Few have seen it Differing degrees of exposure to and experience with bup Different local conditions do affect thinking and attitudes

3. Bay Area Addiction, Research and Treatment (BAART) In operation for 30 years 14 treatment programs (12/2) 5,000 + patients in treatment Evidence-based treatment philosophy Participates in the NIDA CTN

4. New CTN “START” Study Hepatic Safety Study Interested in gaining more experience with bup Wider exposure with immediate community Interested to see if bup has “curb” appeal? How will staff respond?

5. Subutex ® and Suboxone ® Two, schedule III, sublingual buprenorphine tablet formulations (2 mg and 8 mg) approved for US use: Subutex ® (buprenorphine alone) Suboxone ® (buprenorphine + naloxone) In contrast, methadone is a schedule II drug Partial mu-opioid agonists Suboxone ® is the focus of US marketing efforts

8. “Methadone is the Gold Standard for treatment of chronic heroin addiction”

9. Buprenorphine is not a substitute for methadone, it is one more choice on the treatment menu. Both are medications which should be used in comprehensive treatment

10. Buprenorphine in the OTP ( a natural and logical venue ) Many years of experience treating opioid addictions All have medical coverage All have experience with medication assisted treatment All have counseling as key component in treatment Ancillary services available

12. Consensus Panel 2003 Recommends counseling for patients receiving bup Counselors in OTPs should receive information and training about bup Concurrent counseling and support services are necessary OTP is preferable for patients needing “higher intensity” treatment

13. Some Specific Treatment Provider Concerns Treatment need far exceeds utilization Educating staff and patients about buprenorphine Addressing 40 years of methadone success Finding “best fit” model for using bup Regulatory issues Cost issues Dispensing logistics

14. cont’d We have very few alternatives – LAAM is dead, Naltrexone was stillborn What if OTP does not embrace and integrate buprenorphine? perceptions accessibility revenue

15. Regulatory Issues DATA 2000 – physicians can use schedule III, IV, V meds in other than OTPs Suboxone and Subutex approved FDA 2002 – approved for the treatment of opioid dependence Interim Final Rule 2003 – approval to use Suboxone/Subutex in OTP

16. Interim Final Rule Use of Suboxone/Subutex must adhere to the same Federal standards as for methadone… (42 C.F.R. 8) State standards may supercede Cannot prescribe only dispense “Take Home” dosing as with methadone 30 patient limit does not apply

17. Survey of 414 MMT Patient’s Interest in Switching to Buprenorphine MMT patients at three OTPs surveyed Los Angeles (BAART) Detroit (JARC) Baltimore (Univ. of Maryland) Inquired about general knowledge of, and interest in, buprenorphine Patients told to assume no cost differential

18. Survey of 414 MMT Patient’s Interest in Switching to Buprenorphine % Who had heard about BUP Overall interest Interest if had heard about BUP Interest if had not heard about BUP

19. Top reasons for wanting to switch to buprenorphine among patients expressing interest † Good for medically-supervised withdrawal Can be taken on 3x per week basis Survey of 414 MMT Patient’s Interest in Switching to Buprenorphine † option for OBOT not listed among choices

20. Need: Demand: Utilization There are 1,110+ licensed OTPs in US 225,000+ patients in methadone maintenance tx 1,000,000 persons addicted to heroin 4.7 million current users of prescription opioids for non-medical purposes –about 1.5 million dependent on or abusing pain rx Treatment admissions for new users increasing

21. Need vs. Utilization

22. Treatment Admissions

23. Phases of Buprenorphine Treatment Dose induction and stabilization Maintenance Medically-supervised withdrawal

24. Rapid and direct dose induction: short-acting opioids Patients taking short-acting opioids (e.g., heroin) can be placed directly on Suboxone ® Most patients complete induction and can achieve a stable dose of medication within 7days Induction should be rapid and doses adjusted to clinical need as quickly as possible to reduce withdrawal and craving and prevent early drop- out

25. Induction from Long-Acting Opioids (methadone) More controlled data are needed to determine optimal strategies for Crossover Current US guidelines recommend lowering dose to the equivalent of about 40 mg of methadone before attempting to transfer Physicians should not necessarily refuse to treat patients on higher doses of methadone or require a substantial lowering of their current medication dose before attempting transfer

26. Phases of Buprenorphine Treatment Dose induction and stabilization Maintenance Medically-supervised withdrawal

27. Buprenorphine, Methadone, LAAM: Opioid-Negative Urine Results Mean % Negative Study Week All Subjects Lo Meth Bup Hi Meth LAAM 1357911131517 0 20 40 60 80 100 19% 40% 39% 49% Johnson et al. (2000)

28. Buprenorphine, Methadone, LAAM: Treatment Retention Percent Retained 0 20 40 60 80 100 1234567891011121314151617 20% Lo Meth 58% Bup 73% Hi Meth 53% LAAM Study Week Johnson et al. (2000)

29. Maintenance Considerations We should consider buprenorphine as a maintenance drug More information would be helpful Regulations must be brought into alignment with clinical opportunity Flexibility of dosing: 3X/wk dosing

30. Phases of Buprenorphine Treatment Dose induction and stabilization Maintenance Medically Supervised Withdrawal

31. Medically supervised withdrawal Good agent for pharmacologic withdrawal from opioids –slow dissociation from receptor, extended duration of action, less/milder withdrawal when discontinued Research more limited in this area but we do know: –Subutex ® /Suboxone ® better than clonidine –Ancillary medications should be made available but not always necessary May help attract more patients into treatment

32. Effective Medically Supervised Withdrawal should: Be the initial step in a treatment continuum Safely control symptoms of withdrawal Engage patients through out the actual withdrawal insuring completion Facilitate their transfer into long term treatment

33. Medically supervised withdrawal: summary l Short-term supervised withdrawal using Suboxone ® and ancillary medications is safe, can maintain good during-treatment compliance and retain patients through the end of the dose taper l Such programs may improve early treatment engagement among patients resistant to maintenance therapy and may provide a gateway to longer-term care l May be a good first-line option for younger users, those with limited treatment histories and/or patients who initially refuse maintenance therapy

34. Evidence support: Summary Safe, well-tolerated, effective and clinically flexible treatment with low abuse potential Good option for maintenance and medically supervised withdrawal Easily integrated into diverse settings (OTP, office, hospital, residential, drug-free, etc.) Potential for enhancing management of special populations As knowledge about buprenorphine expands within OTPs, patient interest also likely to increase

35. Training/Education OTP staff are knowledgeable about methadone treatment Ongoing training in OTP is mandatory Staff understanding regarding bup varies enormously Three levels of educational need: Medical Counselors Patient

36. Training cont’d Numerous physician trainings – various professional organizations ATTC non-physician clinician courses New Treatment Improvement Protocol (TIP) #40 NIDA & CSAT/SAMHSA Websites Online Courses

37. http://www.danyalearningcenter.org CEATTC Website Online Buprenorphine Training Course for Counselors

38. Education is only a first step: Diffusion of innovation requires a champion and opinion makers Everett Rogers

39. Some possible models Use under current OTP license Operation Par, FL Use under program physician DEA waiver 14 th St, Oakland Bup “induction centers” Kleber, NY Bup “clinic” in OTP Satellite Centers “Hub and Spoke”

40. Attractive and Interesting Offers providers an alternative May be attractive to specific populations Offers 3X/week dosing Does not carry “stigma” May offer more comfortable taper

41. On the other hand….

42. Old Adage The proverbial…”elephant sitting in the middle of the living room but…”

43. $ Cost $

44. Treatment Provider Cost Issues Current price for bup 8mg tab $4.50 2mg tab $2.50 Average dose 12 – 16mg/day Estimated monthly cost for 16mg/day = $270.00 meds only Who’s going to pay?

45. Cost cont’d Not on all State Medicaid formularies Even where it is may be difficulties Some HMO’s “Kaiser” are paying Some insurance plans are paying TAR (treatment authorization request) Contracts - “bundled rates” Cash/self-pay

46. What works what doesn’t ( Most “cluck for your buck”) We need to determine the best“fit” for bup? Short-term detoxification Moderate-long term detoxification Maintenance Tapering off methadone All of the above?

48. The Legacy 4 of original 6 drug free (0001) sites are continuing to utilize bup  Betty Ford Center, CA  Operation PAR, FL  Center for Drug Free Living, FL  Maryhaven, OH

49. Possible gateway to more treatment 54 31 56 32 84 82 0 20 40 60 80 100 Completed DetoxificationContinued in Treatment Prior To BNX No BNX BNX TX % of Patients * * Brigham et al., CPDD2004

50. Knowledge Gained/Lessons Learned  Medication trials can be done successfully in community treatment programs  Old dogs can learn new tricks  Patients really liked bup  Patients really don’t like clonidine  Buprenorphine as and alternative to methadone seems viable in the OTP*

51. Some conclusions Buprenorphine offers one effective treatment option for opioid dependence in OTP We must quickly develop “user friendly” regulations which remove obstacles to using bup in OTP Some ways must be created which address the cost of treatment using bup

52. Thoughts for future use of bup in OTP  Few OTPs currently using bup in US- many are talking about it  Staff and patient education needs to be ongoing  Acceptance will be gradual  Swimming against 50 years of methadone  User friendly legislation must be in place – * Prescribe verses Dispense * Take home policies

53. Thoughts cont’d  Need to keep looking for best applications  Bup in OTP is natural/logical  LAAM is gone: Naltrexone was stillborn

54. Conclusion Buprenorphine is a viable treatment option for opioid abuse in both inpatient and outpatient settings. We must quickly develop funding mechanisms which will make it possible to expand bup use in these settings.

55. Can we afford not to adopt and integrate buprenorphine into opioid treatment programs? If we do not others will….

56. Thanks to: American Association for the Treatment of Opioid Dependence Walter Ling MD Albert Hasson MSW, UCLA ISAP Leslie Amass PhD, Friends Research Judy Martin MD, 14 th Street Evan Kletter PhD, BAART Jason Kletter PhD, BAART