Effective Treatment of Hepatitis C in Substance Users

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Opiate Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Modified Directly Observed Therapy (mDOT)

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

Group Type EXPERIMENTAL

Modified Directly Observed Therapy (mDOT)

Intervention Type PROCEDURE

Self-Administered Therapy at Liver Specialty Clinic (SAT)

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

Group Type ACTIVE_COMPARATOR

Self-Administered Therapy (SAT)

Intervention Type PROCEDURE

Interventions

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Modified Directly Observed Therapy (mDOT)

Intervention Type PROCEDURE

Self-Administered Therapy (SAT)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No