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Effective Treatment of Hepatitis C in Substance Users

Primary Purpose

Hepatitis C, Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Directly Observed Therapy (mDOT)
Self-Administered Therapy (SAT)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • South Central Rehabilitation Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Directly Observed Therapy (mDOT)

Self-Administered Therapy at Liver Specialty Clinic (SAT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With a Sustained Virologic Response (SVR)
SVR is defined as continued undetectable HCV viral load at 24 weeks

Secondary Outcome Measures

Full Information

First Posted
February 29, 2008
Last Updated
January 1, 2013
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00633243
Brief Title
Effective Treatment of Hepatitis C in Substance Users
Official Title
Effective Treatment of Hepatitis C in Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Opiate Dependence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Directly Observed Therapy (mDOT)
Arm Type
Experimental
Arm Description
Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)
Arm Title
Self-Administered Therapy at Liver Specialty Clinic (SAT)
Arm Type
Active Comparator
Arm Description
Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy
Intervention Type
Procedure
Intervention Name(s)
Modified Directly Observed Therapy (mDOT)
Intervention Type
Procedure
Intervention Name(s)
Self-Administered Therapy (SAT)
Primary Outcome Measure Information:
Title
Number of Participants With a Sustained Virologic Response (SVR)
Description
SVR is defined as continued undetectable HCV viral load at 24 weeks
Time Frame
24 weeks (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Douglas Bruce, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Central Rehabilitation Agency
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effective Treatment of Hepatitis C in Substance Users

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