Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
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|ClinicalTrials.gov Identifier: NCT00682591|
Recruitment Status : Withdrawn (Study had to be withdrawn because financial support was cancelled.)
First Posted : May 22, 2008
Last Update Posted : February 4, 2009
Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany.
- 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
|Condition or disease|
|Chronic Hepatitis C Infection|
|Study Type :||Observational|
|Estimated Enrollment :||190 participants|
|Official Title:||Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients (Methadone, Buprenorphine, Suboxone) Under Hepatitis C Therapy (Peginterferon Alfa and Ribavirin)|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
- Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance) [ Time Frame: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682591
|Med. Klinik und Poliklinik II, University of Wuerzburg|
|Wuerzburg, Germany, 97070|
|Principal Investigator:||Michael Scheurlen, MD||Med. Klinik und Poliklinik II, University of Wuerzburg|