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 virus (HCV) infection. This will be done by testing two interventions designed to improve the rates of HCV treatment completion and sustained virologic response (SVR) in IDUs. The first will increase access by integrating HCV medical care into substance abuse treatment, and the second will use voucher incentives to reduce drug and alcohol use among IDUs with HCV infection. 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 engage in active drug and alcohol use, making them ineligible for treatment. Continued drug and alcohol use also worsens HCV outcomes by reducing adherence to HCV treatment and reducing the effectiveness of treatment. The proposed project is a five-year program of work made up of two controlled clinical trials, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT). Study 1 - Integrated HCV Medical Care - 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 GI Clinic. HCV antibody positive MMT patients 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. Study 2 - Voucher Incentives to Reduce Drug Alcohol Use - is a randomized trial of voucher-based incentives to reduce heroin, cocaine, and alcohol use and to thereby increase the rates of completion of HCV treatment and achieving SVR. Eighty HCV antibody positive MMT patients will be randomly assigned to one of two study conditions: a) Voucher group in which participants can earn vouchers with monetary value as incentives for drug and alcohol-free urine tests, and b) No Voucher control group. The main outcomes will be completion of HCV medical treatment, SVR and other HCV-related health measures, and quality of life. These studies are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will also provide information about how HCV treatment outcomes are affected by incentives to reduce drug/alcohol use in MMT patients with chronic HCV. Finally, the studies will also provide information about the influence of active drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA016764-03
Application #
6928442
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Khalsa, Jagjitsingh H
Project Start
2003-09-26
Project End
2008-06-30
Budget Start
2005-07-01
Budget End
2006-06-30
Support Year
3
Fiscal Year
2005
Total Cost
$861,193
Indirect Cost
Name
Upstate Medical University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
058889106
City
Syracuse
State
NY
Country
United States
Zip Code
13210
Batki, Steven L; Canfield, Kelly M; Ploutz-Snyder, Robert (2011) Psychiatric and substance use disorders among methadone maintenance patients with chronic hepatitis C infection: effects on eligibility for hepatitis C treatment. Am J Addict 20:312-8
Canfield, Kelly M; Smyth, Emily; Batki, Steven L (2010) Methadone maintenance patients' knowledge, attitudes, beliefs, and experiences concerning treatment for hepatitis C virus infection. Subst Use Misuse 45:496-514
Karila, Laurent; Weinstein, Aviv; Aubin, Henri-Jean et al. (2010) Pharmacological approaches to methamphetamine dependence: a focused review. Br J Clin Pharmacol 69:578-92
Batki, Steven L; Canfield, Kelly M; Smyth, Emily et al. (2010) Hepatitis C treatment eligibility and comorbid medical illness in methadone maintenance (MMT) and non-MMT patients: a case-control study. J Addict Dis 29:359-69
Batki, Steven L; Canfield, Kelly M; Smyth, Emily et al. (2009) Health-related quality of life in methadone maintenance patients with untreated hepatitis C virus infection. Drug Alcohol Depend 101:176-82
Alleyne, Shirley; Alao, Adekola; Batki, Steven L (2006) Lamotrigine-associated rash and blood dyscrasias in a methadone-treatment patient with hepatitis C. Psychosomatics 47:257-8