Effective Treatment of Hepatitis C in Substance Users

Hepatitis C Clinical Trial

Official title:

Effective Treatment of Hepatitis C in Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633243
• Other study ID #: 0702002306
• Secondary ID: NIDA 022143
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: January 1, 2013
• Start date: April 2007
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Opiate Dependence

Intervention

Procedure:
• Modified Directly Observed Therapy (mDOT)

• Self-Administered Therapy (SAT)

Locations

Country	Name	City	State
United States	South Central Rehabilitation Agency	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Sustained Virologic Response (SVR)	SVR is defined as continued undetectable HCV viral load at 24 weeks	24 weeks (end of treatment)	No