N/A N=21 Randomized Health Services Research

Effective Treatment of Hepatitis C in Substance Users

Hepatitis C · Opiate Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00633243 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Number of Participants With a Sustained Virologic Response (SVR) — 7; 1 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Modified Directly Observed Therapy (mDOT) (Procedure); Self-Administered Therapy (SAT) (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Sustained Virologic Response (SVR)	7; 1	—

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.

Eligibility 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 and VL>5, 000 copies/mL
Platelet count < 75,000 /mL
Hemoglobin < 10 mg/dL
Absolute neutrophil count <1500 cells/mL

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00633243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.