Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
Study Details
Study Description
Brief Summary
Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany.
Aims:
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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.
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
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Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin.
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Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
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Patients with baseline monitoring of emotional state and neurocognitive performance.
Exclusion Criteria:
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According to SPC
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According to legal requirements reg. drug substitution therapy (BTMVV)
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Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance).
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Age under 18 years or over 65 years
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coinfections such as hepatitis B virus or human immunodeficiency virus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Med. Klinik und Poliklinik II, University of Wuerzburg | Wuerzburg | Germany | 97070 |
Sponsors and Collaborators
- University of Wuerzburg
Investigators
- Principal Investigator: Michael Scheurlen, MD, Med. Klinik und Poliklinik II, University of Wuerzburg
Study Documents (Full-Text)
None provided.More Information
Publications
- Kraus MR, Schäfer 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.
- Kraus MR, Schäfer 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.
- Schäfer A, Scheurlen M, Weissbrich B, Schöttker 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. Epub 2007 May 10.
- Schäfer 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. Review.
- P05595