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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
  Purpose

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.


Condition Intervention
Hepatitis C
Opiate Dependence
 Procedure: Modified Directly Observed Therapy (mDOT)
Procedure: Self-Administered Therapy (SAT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effective Treatment of Hepatitis C in Substance Users

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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


Enrollment: 21
Study Start Date: April 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified Directly Observed Therapy (mDOT)
Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)
 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
 Procedure: Self-Administered Therapy (SAT)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633243

Locations
United States, Connecticut
South Central Rehabilitation Agency
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: R. Douglas Bruce, M.D. Yale University
  More Information

No publications provided

Responsible Party: R. Douglas Bruce, MD, MA, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00633243     History of Changes
Other Study ID Numbers: 0702002306, NIDA 022143
Study First Received: February 29, 2008
Results First Received: October 19, 2012
Last Updated: January 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013