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Effective Treatment of Hepatitis C in Substance Users

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ClinicalTrials.gov Identifier: NCT00633243
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : November 20, 2012
Last Update Posted : January 3, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Hepatitis C
Opiate Dependence
Interventions Procedure: Modified Directly Observed Therapy (mDOT)
Procedure: Self-Administered Therapy (SAT)
Enrollment 21
Recruitment Details Subjects were recruited over a 3-year period (2007-2010) from a substance abuse treatment clinic in New Haven, CT. Those with evidence of infection with HCV were subsequently seen by a medical provider to evaluate for HCV treatment, and if found to be appropriate, were referred to the research assistant.
Pre-assignment Details Subjects were eligible for participation if they were prescribed methadone and were opioid negative in the past 30 days, age 18 years or older, underwent documented HIV testing, competent to provide informed consent, had stable mental health status, and met the following criteria for HCV treatment: detectable HCV RNA and genotype testing.
Arm/Group Title Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Hide Arm/Group Description Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV. Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
Period Title: Overall Study
Started 12 9
Completed 11 2
Not Completed 1 7
Reason Not Completed
Withdrawal by Subject             0             1
incarceration             0             2
Homeless--no refrigeration for meds             0             1
Not comfortable with self-injecting             0             1
Mental Health--Depression             0             1
Couldn't tolerate side-effects             1             1
Arm/Group Title Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT) Total
Hide Arm/Group Description Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV. Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work. Total of all reporting groups
Overall Number of Baseline Participants 12 9 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 9 participants 21 participants
40
(29 to 51)
43
(36 to 54)
42
(29 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 21 participants
Female
7
  58.3%
3
  33.3%
10
  47.6%
Male
5
  41.7%
6
  66.7%
11
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 9 participants 21 participants
12 9 21
1.Primary Outcome
Title Number of Participants With a Sustained Virologic Response (SVR)
Hide Description SVR is defined as continued undetectable HCV viral load at 24 weeks
Time Frame 24 weeks (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in mDOT arm and SAT arm who completed treatment.
Arm/Group Title Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Hide Arm/Group Description:
Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
Overall Number of Participants Analyzed 12 4
Measure Type: Number
Unit of Measure: participants
7 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Hide Arm/Group Description Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV. Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
All-Cause Mortality
Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modified Directly Observed Therapy (mDOT) Self-Administered Therapy (SAT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/9 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: R. Douglas Bruce
Organization: Yale University
Phone: (203) 737-6133
EMail: robert.bruce@yale.edu
Layout table for additonal information
Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00633243    
Other Study ID Numbers: 0702002306
NIDA 022143
First Submitted: February 29, 2008
First Posted: March 11, 2008
Results First Submitted: October 19, 2012
Results First Posted: November 20, 2012
Last Update Posted: January 3, 2013