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

Chronic Hepatitis C Infection Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00682591
• Other study ID #: P05595
• Status: Withdrawn
• Phase: N/A
• First received: May 20, 2008
• Last updated: February 3, 2009
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2009
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 190
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Germany	Med. Klinik und Poliklinik II, University of Wuerzburg	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Kraus MR, Schäfer 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. — View Citation

Kraus MR, Schäfer 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. — View Citation

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. — View Citation

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. doi: 10.1002/mpr.229. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)		Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment	No