Official Title: “Improving Hepatitis C Treatment in Injection Drug Users”

The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection.

Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. This will be done by testing an intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs. This intervention will increase access by integrating HCV medical care into a substance abuse treatment program. HCV infection is endemic among IDUs, and is associated with significant medical morbidity. While antiviral treatments are improving rapidly, providing HCV medical care for IDUs remains problematic for a number of reasons. IDUs often do not have adequate access to HCV diagnosis and treatment services, and they may have co-morbid psychiatric diagnoses that affect the ability to withstand the demands of HCV treatment. Therefore, this study will also examine psychiatric disorders and psychiatric symptoms in IDUs who are infected with Hepatitis C virus.

The proposed project is a five-year program consisting of a controlled clinical trial, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT).

The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology (GI) Clinic.

HCV antibody positive MMT patients (N=220) will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic, or through usual off-site referral to the GI Clinic. The main outcomes will be the rates of attaining SVR and completion of HCV treatment, as well as other measures of HCV-related health outcomes and quality of life. Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study.

Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV (SCID) and psychiatric symptom severity will be assessed for depression, mania, anxiety, and psychosis. Drug use measures, and quality of life measures will also be obtained. These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before, during, and after HCV medical care. Finally, the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.

Intervention(s) in this Clinical Trial

• Drug: Pegylated Interferon and Ribavirin
  • Both groups with receive the same medical intervention but offered at different locations
• Behavioral: Psychosocial
  • Assessment of the likelihood of HCV treatment initiation and completion
• Behavioral: On-site (MMT Clinic) HCV evaluation and treatment
  • Standard HCV treatment with Pegylated Interferon and Ribavirin
• Behavioral: Off-site HCV evaluation and treatment
  • Standard HCV treatment with Pegylated Interferon and Ribavirin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • On-site (MMT Clinic) HCV evaluation and treatment
• Active Comparator: 2
  • Off-site (GI Clinic) HCV evaluation and treatment

Primary Measures

• Efficacy of On-site versus Off-site delivery of HCV medical care for methadone maintenance treatment (MMT) patients, as evaluated by the proportion of patients achieving sustained virological response (SVR).
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• psychiatric diagnoses and symptom severity
  • Time Frame: 5 years
    Safety Issue?: No

Inclusion Criteria:

• 1. 18-65 years of age.
• 2. Enrolled in outpatient methadone maintenance treatment for greater than 3 months.
• 3. Hepatitis C RNA positive.
• 4. Willingness to accept HCV treatment.
• 5. Subject has non-VA (Veteran's Administration) medical insurance or is willing to bear any and all expenses associated with Hepatitis C medical treatment.

Exclusion Criteria:

• 1. In need of inpatient drug or alcohol detoxification.
• 2. Currently receiving the standard Hepatitis C treatment
• 3. Unable to give adequate informed consent.
• 4. Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
• 5. Male subject who has a female sexual partner who is pregnant or planning to become pregnant at any time during HCV treatment or within 6 months following completion of treatment.
• 6. Female subject or male subject who has a female sexual partner who is of child bearing years and not using two medically approved forms of contraception.
• 7. Subject has made a commitment to attend residential care psychiatric or drug/alcohol rehabilitation, which would lead to unavailability to attend regularly scheduled medical care and research visits.
• 8. Subject did not attend all required screening appointments.
• 9. Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Steven L Batki, MD Principal Investigator State University of New York, Upstate Medical University - Department of Psychiatry  

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00148031

Study ID Number: SUNY UMU IRB # 4929

ClinicalTrials.gov Identifier: NCT00148031

Health Authority: United States: Federal Government

State University of New York, Upstate Medical University

Crouse Hospital, Chemical Dependency Treatment Services