Improving Hepatitis C Treatment in Injection Drug Users

NCT00148031 | Completed Phase 4 DMC

• 2 other identifiers: SUNY UMU IRB # 4929R01DA016764
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis C; Liver Diseases; Drug Abuse; Alcoholism

Keywords

behavior modification; health care service utilization; hepatitis C,; injection drug use; therapy compliance; alcoholism; alcohol abuse; prevention; drug abuse; liver disorder; HCV; methadone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• psychiatric diagnoses and symptom severity

  5 years

Study Arms (2)

1

EXPERIMENTAL

On-site (MMT Clinic) HCV evaluation and treatment

Drug: Pegylated Interferon and Ribavirin; Behavioral: Psychosocial; Behavioral: On-site (MMT Clinic) HCV evaluation and treatment

2

ACTIVE COMPARATOR

Off-site (GI Clinic) HCV evaluation and treatment

Drug: Pegylated Interferon and Ribavirin; Behavioral: Psychosocial; Behavioral: Off-site HCV evaluation and treatment

Interventions

Pegylated Interferon and Ribavirin DRUG

Both groups with receive the same medical intervention but offered at different locations

1; 2

Psychosocial BEHAVIORAL

Assessment of the likelihood of HCV treatment initiation and completion

1; 2

On-site (MMT Clinic) HCV evaluation and treatment BEHAVIORAL

Standard HCV treatment with Pegylated Interferon and Ribavirin

1

Off-site HCV evaluation and treatment BEHAVIORAL

Standard HCV treatment with Pegylated Interferon and Ribavirin

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• In need of inpatient drug or alcohol detoxification.
• Currently receiving the standard Hepatitis C treatment
• Unable to give adequate informed consent.
• Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
• 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.
• 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.
• 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.
• Subject did not attend all required screening appointments.
• Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (2)

Crouse Chemical Dependency Treatment Services

Syracuse, New York, 13210, United States

Location

SUNY Upstate Medical University - Department of Gastroenterology

Syracuse, New York, 13210, United States

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 patients with untreated hepatitis C virus infection. American Journal on Addictions, 16:316-17.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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 of a trial of co-located treatment. College on the Problems of Drug Dependence, Quebec City, June 2007

  RESULT

• 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 Meeting, San Juan, Puerto Rico June, 2008

  RESULT

Related Links

• State University of New York, Upstate Medical University

MeSH Terms

Conditions

Hepatitis C; Liver Diseases; Substance-Related Disorders; Alcoholism; Patient Acceptance of Health Care; Patient Compliance; Digestive System Diseases

Interventions

Ribavirin; Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Steven L Batki, MD

  State University of New York, Upstate Medical University - Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

US (2)