Status:

COMPLETED

Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Roche Pharma AG

Conditions:

Hepatitis C

Substance Use Disorders

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate c...

Detailed Description

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate c...

Eligibility Criteria

Inclusion

  • Patient has confirmed diagnosis of HCV;
  • Patient has expressed an interest in undergoing interferon treatment;
  • Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
  • Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
  • Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.

Exclusion

  • Patient has a diagnosis of schizophrenia, psychosis;
  • Patient resides in a psychiatric residential facility;
  • Patient attempted suicide in the past five years;
  • Patient is a current intravenous drug user;
  • Patient is cognitively or decisionally-impaired due to brain disease or injury;
  • Patient has advanced liver disease that precludes them from interferon treatment;
  • Patient has other medical comorbidities that may exclude them from interferon treatment;
  • Patient does not want to pursue interferon treatment at the present time;
  • Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;
  • No access to telephone service;
  • Non-English speaking.

Key Trial Info

Start Date :

January 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT00407732

Start Date

January 1 2007

End Date

October 1 2011

Last Update

January 25 2012

Active Locations (1)

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1

Unversity of North Carolina

Chapel Hill, North Carolina, United States, 27599