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