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This study has been withdrawn prior to enrollment.

(Study had to be withdrawn because financial support was cancelled.)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

History of Changes

Purpose

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

Condition
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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682591

Locations

Germany
Med. Klinik und Poliklinik II, University of Wuerzburg
Wuerzburg, Germany, 97070

Sponsors and Collaborators

University of Wuerzburg

Investigators

Principal Investigator:

Michael Scheurlen, MD

Med. Klinik und Poliklinik II, University of Wuerzburg

More Information

Publications:

Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100.

Schäfer A, Scheurlen M, Weissbrich B, Schöttker K, Kraus MR. Sustained virological response in the antiviral therapy of chronic hepatitis C: is there a predictive value of interferon-induced depression? Chemotherapy. 2007;53(4):292-9. Epub 2007 May 10.

Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14.

Schäfer A, Wittchen HU, Seufert J, Kraus MR. Methodological approaches in the assessment of interferon-alfa-induced depression in patients with chronic hepatitis C - a critical review. Int J Methods Psychiatr Res. 2007;16(4):186-201. Review.

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

Keywords provided by University of Wuerzburg:

hepatitis C
drug substitution
neurocognitive
patients with stable drug substitution therapy
patients with interferon-based antiviral therapy

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013

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