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Effective Treatment of Hepatitis C in Substance Users

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier:
NCT00633243
First received: February 29, 2008
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Hepatitis C
Opiate Dependence
Interventions: Procedure: Modified Directly Observed Therapy (mDOT)
Procedure: Self-Administered Therapy (SAT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Modified Directly Observed Therapy (mDOT) 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.
Self-Administered Therapy (SAT) 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.

Participant Flow:   Overall Study
    Modified Directly Observed Therapy (mDOT)     Self-Administered Therapy (SAT)  
STARTED     12     9  
COMPLETED     11     2  
NOT COMPLETED     1     7  
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  



  Baseline Characteristics
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Reporting Groups
  Description
Modified Directly Observed Therapy (mDOT) 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.
Self-Administered Therapy (SAT) 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 Total of all reporting groups

Baseline Measures
    Modified Directly Observed Therapy (mDOT)     Self-Administered Therapy (SAT)     Total  
Number of Participants  
[units: participants]
 		  12     9     21  
Age  
[units: years]
Mean ( Full Range ) 		  40  
  ( 29 to 51 )   		  43  
  ( 36 to 54 )   		  42  
  ( 29 to 54 )  
Gender  
[units: participants]
 		     
Female     7     3     10  
Male     5     6     11  
Region of Enrollment  
[units: participants]
 		     
United States     12     9     21  



  Outcome Measures

1.  Primary:   Number of Participants With a Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks (end of treatment) ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: R. Douglas Bruce
Organization: Yale University
phone: (203) 737-6133
e-mail: robert.bruce@yale.edu


No publications provided


Responsible Party: R. Douglas Bruce, MD, MA, Yale University
ClinicalTrials.gov Identifier: NCT00633243     History of Changes
Other Study ID Numbers: 0702002306, NIDA 022143
Study First Received: February 29, 2008
Results First Received: October 19, 2012
Last Updated: January 1, 2013
Health Authority: United States: Institutional Review Board