Clinical trial NCT00682591: Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C Infection
Keywords: hepatitis C
drug substitution
neurocognitive
patients with stable drug substitution therapy
patients with interferon-based antiviral therapy
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with chronic hepatitis C infection and drug substitution therapy (methadone, burpenorphine, suboxone)

Brief 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


Eligibility 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

Primary outcomes:
measure: Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
timeFrame: Repeated measures design with the following evaluation timepoints: baseline, twice to four times during antiviral treatment, twice after antiviral treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Med. Klinik und Poliklinik II, University of Wuerzburg
Study officials:
affiliation: Med. Klinik und Poliklinik II, University of Wuerzburg
name: Michael Scheurlen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.clpt.2004.09.007.
citation: Schafer A, Scheurlen M, Weissbrich B, Schottker 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. doi: 10.1159/000102584. Epub 2007 May 10.
citation: 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. doi: 10.4088/jcp.v64n0614.
citation: Schafer 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.