Hepatitis C Clinical Trial
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Crouse Chemical Dependency Treatment Services | Syracuse | New York |
United States | SUNY Upstate Medical University - Department of Gastroenterology | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York - Upstate Medical University |
United States,
Batki, S.L., Canfield, K., Lundell, S., Levine, R., Donohue, L., Amodio, K. (oral presentation) Characteristics of opioid-dependent patients seeking Hepatitis C treatment. College on the Problems of Drug Dependence, Orlando, June.
Batki, S.L., Canfield, K.M., Cole, C., Ploutz-Snyder, R., Dimmock, J., Pham, H., Smythe, E. (oral presentation) Quality of life in MMT patients with untreated HCV infection. College on the Problems of Drug Dependence, Scottsdale, June 2006.
Batki, S.L., Canfield, K.M., Cole, C., Smyth, E., Pham, H., Ploutz-Snyder, R.; Amodio, K., Manser, K., Knoeller, G., Strutynski, K., Levine, R., Dimmock J.A. (2007) (abstract) Psychiatric diagnosis and psychiatric symptom severity in methadone treatment p
Batki, S.L., Canfield, K.M., Smyth, E., Amodio, K., Manser, K., Levine, R.A. (poster presentation) Effects of medical and psychiatric comorbidity on HCV treatment eligibility in methadone maintenance. College on the Problems of Drug Dependence, Annual Mee
Batki, S.L., Srinath, A.K., Cornell, M.E., Bowman, M., Peek, R.M.H., Wade, M., Dimmock, J., Abdul-Hamid, M. (2005) Depression and Substance Use in Methadone Patients with Hepatitis C. American Journal on Addictions 14:304-5.
Batki, S.L.; Canfield, K.; Cole, C.; Smyth, E.; Ploutz-Snyder, R.; Levine, R.; Amodio, K.; Knoeller, G.; Strutynski, K.; Manser, K.; Dimmock, J.A. (oral presentation) Hepatitis C treatment progress by methadone maintenance patients: Preliminary analysis o
Cornell, M.E., Peek, R.M.H., Batki, S.L. (2002) Hepatitis C in an Upstate New York methadone treatment population: Preliminary analysis. Drug and Alcohol Dependence 66:S36-37.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 5 years | No | |
Secondary | psychiatric diagnoses and symptom severity | 5 years | No |
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