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Effective Treatment of Hepatitis C in Substance Users
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Yale University.   Recruitment status was  Recruiting

First Received on February 29, 2008.   Last Updated on August 18, 2009   History of Changes
Sponsor: Yale University
Collaborator: National Institute on Drug Abuse (NIDA)
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00633243
  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: Methadone and standard HCV therapy
Procedure: Methadone and directly observed HCV therapy
Procedure: Buprenorphine and directly observed HCV therapy
Procedure: Buprenorphine and standard HCV therapy

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Sustained virologic response [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 4, 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 ]

Estimated Enrollment: 125
Study Start Date: April 2007
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 BUP-DOT Procedure: Buprenorphine and directly observed HCV therapy
Patients on buprenorphine receive weekly shots of pegylated-interferon from medical staff. They self-administer the ribavirin without staff observation, and ribavirin refilled weekly.
Experimental: 1 MMT-DOT Procedure: Methadone and directly observed HCV therapy
Patients on methadone receive ribavirin pills from the methadone window daily. Once a week, they also receive a shot of pegylated-interferon from medical staff.
Active Comparator: 2 MMT-SOC Procedure: Methadone and standard HCV therapy
Patients on methadone self-administer ribavirin and pegylated-interferon without staff observation.
Active Comparator: 4 BUP-SOC Procedure: Buprenorphine and standard HCV therapy
Patients on buprenorphine self-administer ribavirin and pegylated-interferon without staff observation. Refills occur monthly, or as the number of buprenorphine take-home doses changes.

  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

Contacts
Contact: Julie M Eiserman, MA 203-785-3670 julie.eiserman@yale.edu

Locations
United States, Connecticut
South Central Rehabilitation Agency Recruiting
New Haven, Connecticut, United States, 06519
Contact: Julie M Eiserman, MA     203-785-3670     julie.eiserman@yale.edu    
Contact: R. Douglas Bruce, MD, MPH     203-314-2860     douglas.bruce@yale.edu    
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, M.D., Yale University School of Medicine AIDS Program
ClinicalTrials.gov Identifier: NCT00633243     History of Changes
Other Study ID Numbers: 0702002306, NIDA 022143
Study First Received: February 29, 2008
Last Updated: August 18, 2009
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
Buprenorphine
 Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012



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