Effective Treatment of Hepatitis C in Substance Users

We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We will test this hypothesis by randomly assigning patients to receive integrated or separated care. The first group will receive Hepatitis C treatment and substance abuse treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. The second group will receive substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C treatment services. These participants will take their medications on their own (without observation).

We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opiate Dependence Opioid-Related Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Central Rehabilitation Agency

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days.
Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA.

Exclusion criteria

Suicidal or homicidal ideation
Psychiatric condition that is not stable
Pregnancy (RBV is a Class C drug during pregnancy)
Pending court case or warrant which would interrupt treatment
Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma
HIV+ with CD4<200 or CD4>200 and VL>5,000 copies/mL
Platelet count < 75,000 /mL
Hemoglobin < 10 mg/dL
Absolute neutrophil count <1500 cells/mL

Treatment and study plan

Modified Directly Observed Therapy (mDOT)

Procedure

Self-Administered Therapy (SAT)

Procedure

Primary outcomes

Number of Participants With a Sustained Virologic Response (SVR)

Time frame: 24 weeks (end of treatment)

SVR is defined as continued undetectable HCV viral load at 24 weeks

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Mar 11, 2008
Registry last updated: Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed