Effective Treatment of Hepatitis C in Substance Users
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| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06519 |
| Conditions: |
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Hepatitis C - Opiate Dependence |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00633243 |
| Primary Contact: |
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Principal Investigator
R. Douglas Bruce, M.D.
Yale University
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06519
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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