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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
* Cost-Benefit and Risk Appraisal of Substitution Treatment
Extract of Objectives
12-MONTH RETENTION
To describe over a period of 12 months:
 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.
Results
1.0
0.9
 Differences in retention rates...
 Differences in concomitant drug use...
 Differences in therapy outcome...
0.8
Retention
rate (%)
0.7
0.6
0.5
...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).
0.4
0.3
small, primary care based settings 699 / 162
0.2
large, specialized substitution centres 443 / 145
0.1
0.0
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
weeks after baseline
Methods
Prestudy
baseline
ATTAINMENT OF TREATMENT TARGETS
2,694 patients
(223 doctors)
large, specialized substitution centres
Representative sample of substitution physicians in Germany (N=3006)
Random sample
8 doctors withdrew participation
Participation at prestudy (Jun-Sep/2003): N=379 physicians
(N = 66 patients)
Prestudy Questionnaire
Maintenance Staff Questionnaire
1st short
assessment
(6-month-fu)
2,223 patients
still in treatment
(215 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
motivation for drugfree therapy
small, primary care based settings
OR 0.41**
reduction of criminal behaviour
OR 0.51***
reduction of health risks
Main Study
9 doctors withdrew participation
(N = 47 patients)
Target week assessment (Feb-Mar/2004)
Small setting
Medium setting
Large setting
(<10 p/d)
(10-40 p/d)
(>40 p/d)
Patients Questionnaire
Urine
Drug Screening
Doctors Questionnaire
2nd short
assessment
(9-month-fu)
2,007 patients
still in treatment
(206 doctors)
development of motivation and relation
OR 0.73**
abstinence of all illegal drugs
reduction of psychiatric co-morbidity
12 doctors withdrew participation
(N = 120 patients)
12-month
follow-up
Follow-Up
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
OR 0.58***
1,631 patients
still in treatment
(194* doctors)
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
social stabilisation
completey opioid-/substitutiondrugfree
6- and 9-month Follow-up Monitoring with Drop-out Documentation
reduction of somatic co-morbidity
Target week assessment of 12-month Follow-up
Patients Questionnaire
Urine
Drug Screening
documentation available of
Doctors Questionnaire
summary
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
reduction of illegal drugs
reduction of legal drugs
0
Conclusion
10
20
30
40
50
60
70
80
100 %
90
References & Publications
 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 12month 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
CONCOMITANT DRUG USE
baseline
positive drug screen (in %)
opiates
methadone*
cocaine
XTC
amphetamine
benzodiazepine
THC
small
setting
13.6
3.6
6.8
0.5
0.9
21.1
38.2
large
setting
18.8
2.3
11.5
0.4
0.4
26.7
52.4
follow-up
sign
p=0.065
p=0.670
p=0.035
p=0.934
p=0.463
p=0.088
p=0.000
small
setting
8.8
2.0
3.1
1.4
0.6
16.0
31.8
large
setting
14.1
0.0
6.2
1.4
0.3
23.8
46.2
sign
p=0.019
-p=0.041
p=0.986
p=0.647
p=0.007
p=0.000
*without methadone-patients
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]
ASAT