Effective Treatment of Hepatitis C in Substance Users

NCT00633243 | Completed Results

• 2 other identifiers: 0702002306NIDA 022143
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Modified Directly Observed Therapy (mDOT)

EXPERIMENTAL

Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)

Procedure: Modified Directly Observed Therapy (mDOT)

Self-Administered Therapy at Liver Specialty Clinic (SAT)

ACTIVE COMPARATOR

Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy

Procedure: Self-Administered Therapy (SAT)

Interventions

Modified Directly Observed Therapy (mDOT) PROCEDURE

Modified Directly Observed Therapy (mDOT)

Self-Administered Therapy (SAT) PROCEDURE

Self-Administered Therapy at Liver Specialty Clinic (SAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

South Central Rehabilitation Agency

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Hepatitis C; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This trial contains a small sample size of patients with considerable comorbidity and is drawn from one specialized treatment setting. Our conclusions will need empiric testing within carefully conducted RCTs.

Results Point of Contact

• Title: R. Douglas Bruce
• Organization: Yale University

robert.bruce@yale.edu

(203) 737-6133

Study Officials

• R. Douglas Bruce, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 11, 2008
• Study Start: April 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 3, 2013
• Results First Posted: November 20, 2012

Record last verified: 2013-01

Locations

US (1)