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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (Study had to be withdrawn because financial support was cancelled.)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
Information provided by:
University of Wuerzburg

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 190 participants
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)
Study Start Date : July 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00682591

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Med. Klinik und Poliklinik II, University of Wuerzburg
Wuerzburg, Germany, 97070
Sponsors and Collaborators
University of Wuerzburg
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Principal Investigator: Michael Scheurlen, MD Med. Klinik und Poliklinik II, University of Wuerzburg
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Responsible Party: Michael Scheurlen, MD (principal investigator), University of Wuerzburg, Germany Identifier: NCT00682591    
Other Study ID Numbers: P05595
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 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:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic