methods results asat extract of objectives cobra*: 1-year retention and outcome of methadone and...

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Methods Results ASAT Extract of Objectives COBRA*: 1-Year Retention and Outcome of Methadone and Buprenorphine Maintenance in Different Care Settings in Germany Apelt SM, Bühringer G, Siegert J, Soyka M & Wittchen H-U Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden Background Conclusion References & Publications Buprenorphine and methadone are two established substitution drugs licensed in many countries for the maintenance treatment of opioid dependence. Little ist known about how these two treatments work under routine care conditions... ...and particular in different provider formats, such as small, primary care based and large, specialized substitution centres. To describe over a period of 12 months: Differences in retention rates... Differences in concomitant drug use... Differences in therapy outcome... ...in a nationally representative sample of N=223 substitution physicians and a total of N=2,694 consecutive patients in substitution treatment. Settings were divided into small, primary care based settings (<10 patients per day) and large, specialized substitution centres (>40 patients per day). 2,694 patients (223 doctors) 2,223 patients still in treatment (215 doctors) 2,007 patients still in treatment (206 doctors) 1,631 patients still in treatment (194* doctors) 405 patients discontinued therapy, reasons were: 1 – death n = 13 2 – disciplinary reasons n = 58 3 – treatment success (clean) n = 55 4 – change to drug-free therapy n = 86 5 – side effects n = 0 6 – change of residence n = 135 7 – other/unknown n = 58 8 doctors withdrew participation (N = 66 patients) 9 doctors withdrew participation (N = 47 patients) 169 patients discontinued therapy, reasons were: 1 – death n = 5 2 – disciplinary reasons n = 29 3 – treatment success (clean) n = 15 4 – change to drug-free therapy n = 37 5 – side effects n = 0 6 – change of residence n = 52 7 – other/unknown n = 31 12 doctors withdrew participation (N = 120 patients) 256 patients discontinued therapy, reasons were: 1 – death n = 10 2 – disciplinary reasons n = 32 3 – treatment success (clean) n = 30 4 – change to drug-free therapy n = 51 5 – side effects n = 0 6 – change of residence n = 67 7 – other/unknown n = 66 baseline 1st short assessment (6-month-fu) 2nd short assessment (9-month-fu) 12-month follow-up summary documentation available of 2,461 patients Response Rate = 91,35% 830 patients with complete drop-out documentation! Reasons for drop-out were: 1 – death n = 28 2 – disciplinary reasons n = 119 3 – treatment success (clean) n = 100 4 – change to drug-free therapy n = 174 5 – side effects n = 0 6 – change of residence n = 254 7 – other/unknown n = 155 The study confirms an overall effectiveness of agonist maintenance treatments in routine care. Small-scale, primary care based settings perform as well or better as large-scale substitution centres... ...suggesting that these primary care based settings might be a promising alternative to improve access to maintenance therapy in underserved areas. Further analyses of possible patient‘ diffences between settings are necessary. Wittchen, H.-U., Apelt, S. M., Soyka, M., Bühringer, G. et al. (2005). Buprenorphine and methadone in the treatment of opioid dependence: methods and design of the COBRA study. International Journal of Methods in Psychiatric Research, 14(1), 14-28 Wittchen, H.-U. (2005). Buprenorphine and Methadone Treatments in Routine Care: Findings from the 12-month COBRA Cohort Study in Germany. Conference Abstract Book, "Safer Options in the Treatment of Opioid Dependence", Day 3, S. 16 Apelt, Sabine M. (2005). Correlates of High-Risk Behavior Among Methadone and Buprenorphine Patients with HIV (COBRA). NIDA 2005 International Forum Abstracts, Page 5 of 52 Apelt, S.M., Siegert, J. & Wittchen, H.-U. (2005). Substitution in Routine Care: Retention Rates after 9 Months of Follow-up (COBRA). WPA-World Congress 2005 Abstract Book, Page 607 Wittchen, H.-U., Apelt, S.M., Mühlig, S. (2005). Die Versorgungslage der Substitutionstherapie. Buchbeitrag in Gerlach, R. & Stöver, H. (Hrsg.) Vom Tabu zur Normalität: 20 Jahre Substitution in Deutschland - Zwischenbilanz und Aufgaben für die Zukunft. Wittchen, H.-U., Apelt, S. M., Christl, B., Hagenau, K. A., Groß, A., Klotsche, J. & Soyka, M. (2004). Die Versorgungspraxis der Substitutionstherapie Opiatabhängiger (COBRA). Suchtmed 6 (1) 80-87 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 sm all,prim ary care based settings 699 /162 large,specialized substitution centres 443 /145 0 10 20 30 40 50 60 70 80 90 100 reduction oflegal drugs reduction ofillegal drugs reduction ofsom atic co-m orbidity com pletey opioid-/substitutiondrugfree social stabilisation reduction ofpsychiatric co-m orbidity abstinence ofall illegal drugs developm entofm otivation and relation reduction ofhealth risks reduction ofcrim inal behaviour m otivation fordrugfree therapy large,specialized substitution centres sm all,prim ary care based settings OR 0.41** OR 0.51*** OR 0.58*** OR 0.73** ATTAINMENT OF TREATMENT TARGETS CONCOMITANT DRUG USE 12-MONTH RETENTION BMBF - Suchtforschungsverbund Sachsen – Bayern Allocating Substance Abuse Treatments to Patient Heterogeneity This work has been prepared in the context of the project F8 “Allocation in substitution treatments – COBRA ( PI) within the Addiction Research Network ASAT (Allocating Substance Abuse Treatments to Patient Heterogeneity).Contact information: e- mail: [email protected] (www.asat-verbund.de ). ASAT is sponsored by a federal grant of the Federal Ministry of Education and Research (01 EB 0440 - 0441, 01 EB 0142). First phases of this project have been funded in addition by an unrestricted educational grant of essex pharma GmbH, Munich, Germany . COBRA contact information: [email protected] baseline follow-up positive drug screen (in %) small setting large setting sign small setting large setting sign opiates 13.6 18.8 p=0.065 8.8 14.1 p=0.019 methadone* 3.6 2.3 p=0.670 2.0 0.0 -- cocaine 6.8 11.5 p=0.035 3.1 6.2 p=0.041 XTC 0.5 0.4 p=0.934 1.4 1.4 p=0.986 amphetamin e 0.9 0.4 p=0.463 0.6 0.3 p=0.647 benzodiazepine 21.1 26.7 p=0.088 16.0 23.8 p=0.007 THC 38.2 52.4 p=0.000 31.8 46.2 p=0.000 *without methadone-patients Target week assessment (Feb-Mar/2004) Small setting (<10 p/d) 6- and 9-month Follow-up Monitoring with Drop-out Documentation Medium setting (10-40 p/d) Large setting (>40 p/d) Target week assessment of 12-month Follow-up Representative sample of substitution physicians in Germany (N=3006) Random sample Participation at prestudy (Jun-Sep/2003): N=379 physicians Patients Questionnaire Doctors Questionnaire Urine Drug Screening Prestudy Questionnaire Maintenance Staff Questionnaire Prestudy Prestudy Main Study Main Study Follow-Up Follow-Up Patients Questionnaire Doctors Questionnaire Urine Drug Screening Retentio n rate (%) weeks after baseline % * Cost-Benefit and Risk Appraisal of Substitution Treatme

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Page 1: Methods Results ASAT Extract of Objectives COBRA*: 1-Year Retention and Outcome of Methadone and Buprenorphine Maintenance in Different Care Settings in

Methods

Results

ASAT

Extract of Objectives

COBRA*: 1-Year Retention and Outcome of Methadone and Buprenorphine Maintenance in Different Care Settings in Germany

Apelt SM, Bühringer G, Siegert J, Soyka M & Wittchen H-U Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden

Background

Conclusion References & Publications

Buprenorphine and methadone are two established substitution drugs licensed in many countries for the maintenance treatment of opioid dependence.

Little ist known about how these two treatments work under routine care conditions...

...and particular in different provider formats, such as small, primary care based and large, specialized substitution centres.

To describe over a period of 12 months:

Differences in retention rates... Differences in concomitant drug use... Differences in therapy outcome...

...in a nationally representative sample of N=223 substitutionphysicians and a total of N=2,694 consecutive patients insubstitution treatment. Settings were divided into small, primarycare based settings (<10 patients per day) and large, specialized substitution centres (>40 patients per day).

2,694 patients(223 doctors)

2,223 patientsstill in treatment

(215 doctors)

2,007 patientsstill in treatment

(206 doctors)

1,631 patientsstill in treatment

(194* doctors)

405 patients discontinued therapy, reasons were:1 – death n = 132 – disciplinary reasons n = 583 – treatment success (clean) n = 554 – change to drug-free therapy n = 865 – side effects n = 06 – change of residence n = 1357 – other/unknown n = 58

8 doctors withdrew participation(N = 66 patients)

9 doctors withdrew participation(N = 47 patients)

169 patients discontinued therapy, reasons were:1 – death n = 52 – disciplinary reasons n = 293 – treatment success (clean) n = 154 – change to drug-free therapy n = 375 – side effects n = 06 – change of residence n = 527 – other/unknown n = 31

12 doctors withdrew participation(N = 120 patients)

256 patients discontinued therapy, reasons were:1 – death n = 102 – disciplinary reasons n = 323 – treatment success (clean) n = 304 – change to drug-free therapy n = 515 – side effects n = 06 – change of residence n = 677 – other/unknown n = 66

baseline

1st short assessment

(6-month-fu)

2nd short assessment

(9-month-fu)

12-monthfollow-up

summary

documentation available of

2,461 patients

Response Rate = 91,35%

830 patients with complete drop-out documentation!Reasons for drop-out were:1 – death n = 282 – disciplinary reasons n = 1193 – treatment success (clean) n = 1004 – change to drug-free therapy n = 1745 – side effects n = 06 – change of residence n = 2547 – other/unknown n = 155

The study confirms an overall effectiveness of agonist maintenance treatments in routine care.

Small-scale, primary care based settings perform as well or better as large-scale substitution centres...

...suggesting that these primary care based settings might be a promising alternative to improve access to maintenance therapy in underserved areas.

Further analyses of possible patient‘ diffences between settings are necessary.

Wittchen, H.-U., Apelt, S. M., Soyka, M., Bühringer, G. et al. (2005). Buprenorphine and methadone in the treatment of opioid dependence: methods and design of the COBRA study. International Journal of Methods in Psychiatric Research, 14(1), 14-28

Wittchen, H.-U. (2005). Buprenorphine and Methadone Treatments in Routine Care: Findings from the 12-month COBRA Cohort Study in Germany. Conference Abstract Book, "Safer Options in the Treatment of Opioid Dependence", Day 3, S. 16

Apelt, Sabine M. (2005). Correlates of High-Risk Behavior Among Methadone and Buprenorphine Patients with HIV (COBRA). NIDA 2005 International Forum Abstracts, Page 5 of 52

Apelt, S.M., Siegert, J. & Wittchen, H.-U. (2005). Substitution in Routine Care: Retention Rates after 9 Months of Follow-up (COBRA). WPA-World Congress 2005 Abstract Book, Page 607

Wittchen, H.-U., Apelt, S.M., Mühlig, S. (2005). Die Versorgungslage der Substitutionstherapie. Buchbeitrag in Gerlach, R. & Stöver, H. (Hrsg.) Vom Tabu zur Normalität: 20 Jahre Substitution in Deutschland - Zwischenbilanz und Aufgaben für die Zukunft.

Wittchen, H.-U., Apelt, S. M., Christl, B., Hagenau, K. A., Groß, A., Klotsche, J. & Soyka, M. (2004). Die Versorgungspraxis der Substitutionstherapie Opiatabhängiger (COBRA). Suchtmed 6 (1) 80-87

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54

small, primary care based settings 699 / 162

large, specialized substitution centres 443 / 145

0 10 20 30 40 50 60 70 80 90 100

reduction of legal drugs

reduction of illegal drugs

reduction of somatic co-morbidity

completey opioid-/substitutiondrugfree

social stabilisation

reduction of psychiatric co-morbidity

abstinence of all illegal drugs

development of motivation and relation

reduction of health risks

reduction of criminal behaviour

motivation for drugfree therapy

large, specialized substitution centres small, primary care based settings

OR 0.41**

OR 0.51***

OR 0.58***

OR 0.73**

ATTAINMENT OF TREATMENT TARGETS

CONCOMITANT DRUG USE

12-MONTH RETENTION

BMBF - Suchtforschungsverbund Sachsen – Bayern Allocating Substance Abuse Treatments to Patient HeterogeneityThis work has been prepared in the context of the project F8 “Allocation in substitution treatments – COBRA (PI) within the Addiction Research Network ASAT (Allocating Substance Abuse Treatments to Patient Heterogeneity).Contact information: e-mail: [email protected] (www.asat-verbund.de).

ASAT is sponsored by a federal grant of the Federal Ministry of Education and Research (01 EB 0440 - 0441, 01 EB 0142). First phases of this project have been funded in addition by an unrestricted educational grant of essex pharma GmbH, Munich, Germany . COBRA contact information: [email protected]

baseline follow-up

positive drug screen (in %)small

settinglarge

setting signsmall

settinglarge

setting sign

opiates 13.6 18.8 p=0.065 8.8 14.1 p=0.019

methadone* 3.6 2.3 p=0.670 2.0 0.0 --

cocaine 6.8 11.5 p=0.035 3.1 6.2 p=0.041

XTC 0.5 0.4 p=0.934 1.4 1.4 p=0.986

amphetamine 0.9 0.4 p=0.463 0.6 0.3 p=0.647

benzodiazepine 21.1 26.7 p=0.088 16.0 23.8 p=0.007

THC 38.2 52.4 p=0.000 31.8 46.2 p=0.000

*without methadone-patients

Target week assessment (Feb-Mar/2004)

Small setting(<10 p/d)

6- and 9-month Follow-up Monitoring with Drop-out Documentation

Medium setting(10-40 p/d)

Large setting (>40 p/d)

Target week assessment of 12-month Follow-up

Representative sample of substitution physicians in Germany (N=3006)

Random sample

Participation at prestudy (Jun-Sep/2003): N=379 physicians

Patients Questionnaire Doctors QuestionnaireUrineDrug Screening

Prestudy Questionnaire Maintenance Staff Questionnaire

PrestudyPrestudy

Main StudyMain Study

Follow-UpFollow-Up

Patients Questionnaire Doctors QuestionnaireUrineDrug Screening

Retention rate (%)

weeks after baseline

%

* Cost-Benefit and Risk Appraisal of Substitution Treatment