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Using Buprenorphine in Opioid Treatment
ProgramsAllan J. Cohen MA, MFT
Director of Research and TrainingBay Area Addiction Research and
Treatment, Inc.(BAART)
American Association for the Treatment of Opioid DependenceAtlanta, GAApril, 2006
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 doaffect thinking and attitudes
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
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?
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
“Methadone is the Gold Standard for treatment of chronic heroin addiction”
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
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
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
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
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
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
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
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
Survey of 414 MMT Patient’s Interest in Switching to Buprenorphine
53.0%
32.0%
46.0%
19.0%
0%
20%
40%
60%
80%
100%
% Who had heard
aboutBUP
Overallinterest
Interest if had heard about BUP
Interest if had not
heard about BUP
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
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
Need vs. Utilization
00.5
11.5
22.5
33.5
44.5
RxMisuse
HeroinDep.
MMT OTPs
Treatment Admissions
Phases of Buprenorphine Treatment
•Dose induction and stabilization
• Maintenance
• Medically-supervised withdrawal
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
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
Phases of Buprenorphine Treatment
• Dose induction and stabilization
• Maintenance
• Medically-supervised withdrawal
Buprenorphine, Methadone, LAAM:Opioid-Negative Urine Results
Mea
n %
Neg
ativ
e
Study Week
All Subjects
Lo Meth
BupHi Meth
LAAM
1 3 5 7 9 11 13 15 170
20
40
60
80
100
19%
40%
39%
49%
Johnson et al. (2000)
Buprenorphine, Methadone, LAAM: Treatment Retention
Per
cent
Ret
aine
d
0
20
40
60
80
100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
20% Lo Meth
58% Bup
73% Hi Meth
53% LAAM
Study Week Johnson et al. (2000)
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
Phases of Buprenorphine
Treatment•Dose induction and stabilization
•Maintenance•Medically Supervised Withdrawal
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
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
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
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
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:
MedicalCounselors Patient
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
http://www.danyalearningcenter.org
CEATTC Website Online Buprenorphine Training Course
for Counselors
Education is only a first step: Diffusion of innovation requires a champion and opinion makers Everett Rogers
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”
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
On the other hand….
Old Adage The proverbial…”elephant
sitting in the middle of the living room but…”
$ Cost $
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?
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
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?
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
Possible gateway to more treatment
54
31
56
32
84 82
0
20
40
60
80
100
Completed Detoxification Continued in Treatment
Prior To BNXNo BNXBNX TX
% o
f P
atie
nts
* *
Brigham et al., CPDD2004
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*
Some conclusionsBuprenorphine 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
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
Thoughts cont’d
Need to keep looking for best applications
Bup in OTP is natural/logical
LAAM is gone: Naltrexone was stillborn
ConclusionBuprenorphine 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.
Can we afford not to adopt and integrate buprenorphine into
opioid treatment programs?
If we do not others will….
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