Effective Treatment of Hepatitis C in Substance Users

Condition(s) targeted: Hepatitis C; Opiate Dependence

Intervention: 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 (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
R. Douglas Bruce, M.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Angela Acosta, Phone: 203-376-0221, Email: angela.acosta@yale.edu

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.

Official title: Effective Treatment of Hepatitis C in Substance Users

Study design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Sustained virologic response

Secondary outcome:

End-of-Treatment Virological Response

Retention in HCV treatment

Self-reported substance abuse

Drug free urine results

Adherence

Reincarceration

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Angela Acosta, Phone: 203-376-0221, Email: angela.acosta@yale.edu

South Central Rehabilitation Agency, New Haven, Connecticut 06519, United States; Recruiting
Angela Acosta, Phone: 203-376-0221, Email: angela.acosta@yale.edu

Starting date: April 2007
Ending date: April 2011
Last updated: May 28, 2008