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Study had to be withdrawn because financial support was cancelled.
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Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany.
Aims:
- Primary objective: To compare the impact of the different substitution drugs (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment.
- Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone
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| Measure | Description | Time Frame |
|---|---|---|
| Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance) | Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)
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| Name | Affiliation | Role |
|---|---|---|
| Michael Scheurlen, MD | Med. Klinik und Poliklinik II, University of Wuerzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med. Klinik und Poliklinik II, University of Wuerzburg | Würzburg | 97070 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15637534 | Background | Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. doi: 10.1016/j.clpt.2004.09.007. | |
| 17496415 | Background | Schafer A, Scheurlen M, Weissbrich B, Schottker K, Kraus MR. Sustained virological response in the antiviral therapy of chronic hepatitis C: is there a predictive value of interferon-induced depression? Chemotherapy. 2007;53(4):292-9. doi: 10.1159/000102584. Epub 2007 May 10. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| 12823087 | Background | Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. doi: 10.4088/jcp.v64n0614. |
| 18188838 | Background | Schafer A, Wittchen HU, Seufert J, Kraus MR. Methodological approaches in the assessment of interferon-alfa-induced depression in patients with chronic hepatitis C - a critical review. Int J Methods Psychiatr Res. 2007;16(4):186-201. doi: 10.1002/mpr.229. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |