Effective Treatment of Hepatitis C in Substance Users

Yale University

Status: Completed

Conditions: Opiate Dependence; Hepatitis C

Treatments: Procedure: Modified Directly Observed Therapy (mDOT); Procedure: Self-Administered Therapy (SAT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00633243

0702002306

NIDA 022143

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Modified Directly Observed Therapy (mDOT)

Experimental group

Description:

Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)

Treatment:

Procedure: Modified Directly Observed Therapy (mDOT)

Self-Administered Therapy at Liver Specialty Clinic (SAT)

Active Comparator group

Description:

Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy

Treatment:

Procedure: Self-Administered Therapy (SAT)