NCT00633243

Effective Treatment of Hepatitis C in Substance Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C
• Opiate Dependence

Interventions

Type	Name	Description
PROCEDURE	Modified Directly Observed Therapy (mDOT)
PROCEDURE	Self-Administered Therapy (SAT)

Timeline

• Start date: 2007-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-03-11
• Last updated: 2013-01-03
• Results posted: 2012-11-20

Locations

1 site across 1 country: United States