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Using Buprenorphine in Opioid Treatment Programs

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Title: Using Buprenorphine in Opioid Treatment Programs


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

6
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7
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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

11
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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
contd
  • 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 Patients 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 Patients Interest in
Switching to Buprenorphine
Who had heard about BUP
Interest if had heard about BUP
Interest if had not heard about BUP
Overall interest
19
Top reasons for wanting to switch to
buprenorphine among patients expressing interest
Survey of 414 MMT Patients Interest in
Switching to Buprenorphine
  • Good for medically-supervised withdrawal
  • Can be taken on 3x per week basis

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 inductionshort-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, LAAMOpioid-Negative
Urine Results
100
All Subjects
80
LAAM
49
60
Bup
40
Hi Meth
Mean Negative
40
39
Lo Meth
20
19
0
1
3
5
7
9
11
13
15
17
Study Week
Johnson et al. (2000)
28
Buprenorphine, Methadone, LAAM Treatment
Retention
100
73 Hi Meth
80
60
58 Bup
Percent Retained
53 LAAM
40
20
20 Lo Meth
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
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
  • 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
  • Such programs may improve early treatment
    engagement among patients resistant to
    maintenance therapy and may provide a gateway to
    longer-term care
  • 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 contd
  • 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
  • 14th 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 proverbialelephant 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
  • Whos going to pay?

45
Cost contd
  • Not on all State Medicaid formularies
  • Even where it is may be difficulties
  • Some HMOs Kaiser are paying
  • Some insurance plans are paying
  • TAR (treatment authorization request)
  • Contracts - bundled rates
  • Cash/self-pay

46
What works what doesnt( Most cluck for your
buck)
  • We need to determine the bestfit for bup?
  • Short-term detoxification
  • Moderate-long term detoxification
  • Maintenance
  • Tapering off methadone
  • All of the above?

47
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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
Prior To BNX


No BNX
100
BNX TX
of Patients
84
82
80
56
54
60
40
32
31
20
0
Completed Detoxification
Continued in Treatment
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 dont 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 contd
  • 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, 14th Street
  • Evan Kletter PhD, BAART
  • Jason Kletter PhD, BAART
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