Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effective Treatment of Hepatitis C in Substance Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hepatitis C Opiate Dependence Procedure: Modified Directly Observed Therapy (mDOT) Procedure: Self-Administered Therapy (SAT) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effective Treatment of Hepatitis C in Substance Users
Study Start Date : April 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633243


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: R. Douglas Bruce, M.D. Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: R. Douglas Bruce, MD, MA, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00633243    
Other Study ID Numbers: 0702002306
NIDA 022143
First Posted: March 11, 2008    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: January 3, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders