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

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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00682591

Enrollment

190

Registered

2008-05-22

Start date

2008-07-31

Completion date

2011-12-31

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Keywords

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results