Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
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
Chronic Hepatitis C Infection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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)|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: 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|