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.

Condition	Intervention	Phase
Hepatitis C Intravenous Drug Abuse Liver Diseases Drug Abuse Alcoholism	Drug: Regulated Interferon and Ribavirin	Phase IV

Further Study Details: 

Primary Outcomes: 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).
Secondary Outcomes: 1) Efficacy of On-site versus Off-site HCV care in increasing the rate of completion of antiviral treatment for chronic Hepatitis C.; 2) Whether MMT patients with HCV who do not choose to initiate HCV treatment have a greater number of Axis I psychiatric diagnoses and higher psychiatric symptoms scores than do MMT patients with HCV who initiate HCV treatment.; 3) Whether MMT patients with HCV have a greater likelihood of having psychiatric symptoms prior to receiving treatment for HCV than do non-MMT patients with HCV.; 4) Whether MMT patients with HCV have a greater likelihood of an increase in psychiatric symptoms scores during HCV treatment as compared to their pretreatment psychiatric symptoms scores.; 5) Measure of the relationship between ongoing drug and alcohol use and HCV treatment completion.; 6) Whether MMT patients with HCV will have a greater number of positive urine drug test results for heroin, cocaine, or marijuana during the HCV treatment phase than during the pretreatment phase of the research study.; 7) Whether MMT patients with HCV who do not choose to initiate HCV treatment have a greater number of positive urine drug tests for heroin, cocaine, or marijuana during the pretreatment phase than do MMT patients with HCV who initiate HCV treatment.
Expected Total Enrollment:  220

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. Patients who are participating in the Medical Care study will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study. The main outcomes will be psychiatric diagnosis using the Structured Psychiatric Interview for the DSM-IV (SCID) and scores using depression, mania, anxiety, and psychosis rating scales, drug use measures, and quality of life measures. 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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. 18-60 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00148031

Kelly Canfield, MSN, FNPC      315-464-3274    canfielk@upstate.edu

New York
      Crouse Chemical Dependency Treatment Services, Syracuse,  New York,  13210,  United States; Recruiting
      SUNY Upstate Medical University - Department of Gastroenterology, Syracuse,  New York,  13210,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  SUNY UMU IRB # 4929; R01 DA016764
Last Updated:  September 7, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00148031
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13