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Effective Treatment of Hepatitis C in Substance Users

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ClinicalTrials.gov Identifier: NCT00633243
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : November 20, 2012
Last Update Posted : January 3, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University

Tracking Information
First Submitted Date  ICMJE February 29, 2008
First Posted Date  ICMJE March 11, 2008
Results First Submitted Date  ICMJE October 19, 2012
Results First Posted Date  ICMJE November 20, 2012
Last Update Posted Date January 3, 2013
Study Start Date  ICMJE April 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Sustained virologic response [ Time Frame: 24 weeks after the end of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
  • End-of-Treatment Virological Response [ Time Frame: 48 or 24 weeks, depending on HCV genotype ]
  • Retention in HCV treatment [ Time Frame: 48 or 24 weeks, depending on HCV genotype ]
  • Self-reported substance abuse [ Time Frame: baseline and 4, 12, 24, 36, 48, and 64 weeks ]
  • Drug free urine results [ Time Frame: weekly ]
  • Adherence [ Time Frame: 1, 12, 24, 36, 48, and 64 weeks ]
  • Reincarceration [ Time Frame: 4, 12, 24, 36, 48, and 64 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effective Treatment of Hepatitis C in Substance Users
Official Title  ICMJE Effective Treatment of Hepatitis C in Substance Users
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Hepatitis C
  • Opiate Dependence
Intervention  ICMJE
  • Procedure: Modified Directly Observed Therapy (mDOT)
  • Procedure: Self-Administered Therapy (SAT)
Study Arms  ICMJE
  • Experimental: Modified Directly Observed Therapy (mDOT)
    Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)
    Intervention: Procedure: Modified Directly Observed Therapy (mDOT)
  • Active Comparator: Self-Administered Therapy at Liver Specialty Clinic (SAT)
    Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy
    Intervention: Procedure: Self-Administered Therapy (SAT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 1, 2013)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 29, 2008)
125
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00633243
Other Study ID Numbers  ICMJE 0702002306
NIDA 022143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R. Douglas Bruce, MD, MA, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: R. Douglas Bruce, M.D. Yale University
PRS Account Yale University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP