Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

This study has been withdrawn prior to enrollment.
(Study had to be withdrawn because financial support was cancelled.)
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00682591
First received: May 20, 2008
Last updated: February 3, 2009
Last verified: February 2009

May 20, 2008
February 3, 2009
July 2008
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00682591 on ClinicalTrials.gov Archive Site
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Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
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)

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)

Chronic Hepatitis C Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
190
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Opioid-dependent patients on current stable agonist maintenance therapy (for at least 6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
  • Patients need to be infected with chronic hepatitis C and must have indication for therapy with peginterferon alfa and ribavirin.
  • Patients with informed written consent with respect to a follow-up of psychiatric side effects and in particular neurocognitive performance.
  • Patients with baseline monitoring of emotional state and neurocognitive performance.

Exclusion Criteria:

  • According to SPC
  • According to legal requirements reg. drug substitution therapy (BTMVV)
  • Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, Test Battery of Attentional Performance).
  • Age under 18 years or over 65 years
  • coinfections such as hepatitis B virus or human immunodeficiency virus
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00682591
P05595
Yes
Michael Scheurlen, MD (principal investigator), University of Wuerzburg, Germany
University of Wuerzburg
Not Provided
Principal Investigator: Michael Scheurlen, MD Med. Klinik und Poliklinik II, University of Wuerzburg
University of Wuerzburg
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP