Effective Treatment of Hepatitis C in Substance Users - Full Text View

Sponsors and Collaborators:	Yale University 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:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effective Treatment of Hepatitis C in Substance Users

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C Urine and Urination

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
3 BUP-DOT: Experimental	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.
1 MMT-DOT: Experimental	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.
2 MMT-SOC: Active Comparator	Procedure: Methadone and standard HCV therapy Patients on methadone self-administer ribavirin and pegylated-interferon without staff observation.
4 BUP-SOC: Active Comparator	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:	Yale University School of Medicine AIDS Program ( R. Douglas Bruce, M.D. )
Study ID Numbers:	0702002306, NIDA 022143
Study First Received:	February 29, 2008
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00633243 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Liver Diseases
Narcotic Antagonists
Ribavirin
Interferons
Central Nervous System Depressants
Hepatitis, Viral, Human
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Naphazoline
Hepatitis
Virus Diseases

Methadone
Buprenorphine
Digestive System Diseases
Guaifenesin
Mental Disorders
Substance-Related Disorders
Phenylpropanolamine
Peripheral Nervous System Agents
Analgesics
Hepatitis C
Analgesics, Opioid

Additional relevant MeSH terms:

Respiratory System Agents
Liver Diseases
Flaviviridae Infections
Physiological Effects of Drugs
Narcotic Antagonists
Disorders of Environmental Origin
Hepatitis, Viral, Human
Opioid-Related Disorders
Buprenorphine
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Hepatitis C

Analgesics
Analgesics, Opioid
RNA Virus Infections
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Virus Diseases
Hepatitis
Methadone
Digestive System Diseases
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009