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Effective Treatment of Hepatitis C in Substance Users

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier:
NCT00633243
First received: February 29, 2008
Last updated: January 1, 2013
Last verified: January 2013
History of Changes

February 29, 2008
January 1, 2013
April 2007
September 2011   (final data collection date for primary outcome measure)
Number of Participants With a Sustained Virologic Response (SVR) [ Time Frame: 24 weeks (end of treatment) ] [ Designated as safety issue: No ]
SVR is defined as continued undetectable HCV viral load at 24 weeks
Sustained virologic response [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633243 on ClinicalTrials.gov Archive Site
Not Provided
  • End-of-Treatment Virological Response [ Time Frame: 48 or 24 weeks, depending on HCV genotype ] [ Designated as safety issue: No ]
  • Retention in HCV treatment [ Time Frame: 48 or 24 weeks, depending on HCV genotype ] [ Designated as safety issue: No ]
  • Self-reported substance abuse [ Time Frame: baseline and 4, 12, 24, 36, 48, and 64 weeks ] [ Designated as safety issue: No ]
  • Drug free urine results [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Adherence [ Time Frame: 1, 12, 24, 36, 48, and 64 weeks ] [ Designated as safety issue: No ]
  • Reincarceration [ Time Frame: 4, 12, 24, 36, 48, and 64 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effective Treatment of Hepatitis C in Substance Users
Effective Treatment of Hepatitis C in Substance Users

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hepatitis C
  • Opiate Dependence
  • Procedure: Modified Directly Observed Therapy (mDOT)
  • Procedure: Self-Administered Therapy (SAT)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633243
0702002306, NIDA 022143
No
R. Douglas Bruce, MD, MA, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: R. Douglas Bruce, M.D. Yale University
Yale University
January 2013

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