Effective Treatment of Hepatitis C in Substance Users

Completed · Not applicable

Conditions studied: Hepatitis C, Opiate Dependence

In brief

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.

Key facts

Study ID

NCT00633243

Run by

Yale University

People needed

21

Starts

2007-04-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• South Central Rehabilitation Agency — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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