Using Buprenorphine in Opioid Treatment Programs

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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

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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

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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

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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?

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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

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Methadone is the Gold Standard for treatment of
chronic heroin addiction
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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
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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

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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

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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

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contd

• We have very few alternatives LAAM is dead,
  Naltrexone was stillborn
• What if OTP does not embrace and integrate
  buprenorphine?
• perceptions
• accessibility
• revenue

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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

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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

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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

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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
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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
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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

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Need vs. Utilization
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Treatment Admissions
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Phases of Buprenorphine Treatment

• Dose induction and stabilization
• Maintenance
• Medically-supervised withdrawal

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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

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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

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Phases of Buprenorphine Treatment

• Dose induction and stabilization
• Maintenance
• Medically-supervised withdrawal

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Buprenorphine, Methadone, LAAMOpioid-Negative
Urine Results
100
All Subjects
80
LAAM
49
60
Bup
40
Hi Meth
Mean Negative
40
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Lo Meth
20
19
0
1
3
5
7
9
11
13
15
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Study Week
Johnson et al. (2000)
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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)
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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

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Phases of Buprenorphine Treatment

• Dose induction and stabilization
• Maintenance
• Medically Supervised Withdrawal

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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

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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

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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

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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

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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

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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

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http//www.danyalearningcenter.org

• CEATTC Website Online Buprenorphine Training
  Course for Counselors

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

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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

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On the other hand.
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Old Adage The proverbialelephant sitting in
the middle of the living room but
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Cost
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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?

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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

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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?

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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

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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
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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

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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

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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

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Thoughts contd

• Need to keep looking for best applications
• Bup in OTP is natural/logical
• LAAM is gone Naltrexone was stillborn

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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.

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