Transcript Using Buprenorphine in Opioid Treatment Programs

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
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
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
100%
80%
60%
40%
53.0%
46.0%
32.0%
20%
19.0%
0%
% Who
had heard
about
BUP
Overall
interest
Interest
if had
heard
about
BUP
Interest
if had not
heard
about
BUP
Survey of 414 MMT Patient’s
Interest in Switching to Buprenorphine
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
†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
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
Rx
Heroin
Misuse Dep.
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 dropout
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
100
All Subjects
Mean % Negative
80
LAAM
49%
60
Bup
Hi Meth
40%
40
39%
Lo Meth
20
19%
0
1
Johnson et al. (2000)
3
5
7
9
11
Study Week
13
15
17
Buprenorphine, Methadone, LAAM:
Treatment Retention
Percent Retained
100
80
73% Hi Meth
60
58% Bup
40
53% LAAM
20
20% Lo Meth
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Johnson et al. (2000)
Study Week
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:
 Medical
Counselors
 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
CEATTC Website Online
Buprenorphine Training Course for
Counselors
http://www.danyalearningcenter.org
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
*
84
% of Patients
100
Prior To BNX
No BNX
BNX TX
*82
80
54
60
56
40
31
32
20
0
Completed Detoxification
Brigham et al., CPDD2004
Continued in Treatment
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 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
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
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.
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