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This study has been withdrawn prior to enrollment.
(Study had to be withdrawn because financial support was cancelled.)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

Chronic Hepatitis C Infection

Study Type: Observational
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)

Resource links provided by NLM:

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 190
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)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)

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
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Please refer to this study by its identifier: NCT00682591

Med. Klinik und Poliklinik II, University of Wuerzburg
Wuerzburg, Germany, 97070
Sponsors and Collaborators
University of Wuerzburg
Principal Investigator: Michael Scheurlen, MD Med. Klinik und Poliklinik II, University of Wuerzburg
  More Information

Responsible Party: Michael Scheurlen, MD (principal investigator), University of Wuerzburg, Germany Identifier: NCT00682591     History of Changes
Other Study ID Numbers: P05595
Study First Received: May 20, 2008
Last Updated: February 3, 2009

Keywords provided by University of Wuerzburg:
hepatitis C
drug substitution
patients with stable drug substitution therapy
patients with interferon-based antiviral therapy

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections processed this record on July 19, 2017