Hepatitis CNCT00633243
Effective Treatment of Hepatitis C in Substance Users
A study testing Modified Directly Observed Therapy (mDOT) and Self-Administered Therapy (SAT) in people with Hepatitis C and Opiate Dependence, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Opiate Dependence
- What is being tested?
- Modified Directly Observed Therapy (mDOT) and Self-Administered Therapy (SAT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Platelet count < 75,000 /mL
- Hemoglobin < 10 mg/dL
- Absolute neutrophil count <1500 cells/mL
Trial locations and contacts
1 site in 1 country.
United States1 site
South Central Rehabilitation Agency
New Haven, Connecticut, 06519
About this study
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
- Being tested
- Modified Directly Observed Therapy (mDOT), Self-Administered Therapy (SAT)
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Directly Observed Therapy (mDOT)Procedure or surgery
Self-Administered Therapy (SAT)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Experimental | Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT) Receives: 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 Receives: Procedure: Self-Administered Therapy (SAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Sustained Virologic Response (SVR)
SVR is defined as continued undetectable HCV viral load at 24 weeks
Measured: 24 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, R. Douglas Bruce, MD, MA, Yale University
- Investigators
- R. Douglas Bruce, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633243
- Sponsor's protocol ID
- 0702002306
- Other IDs
- NIDA 022143
- Status last verified
- Jan 2013
- First submitted
- 29 Feb 2008
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatment of Hepatitis C in Substance Users
- ClinicalTrials.gov ID
- NCT00633243
- Acronym / sponsor ID
- 0702002306
- Conditions
- Hepatitis C, Opiate Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Experimental | Procedure: Modified Directly Observed Therapy (mDOT)Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT) |
| Self-Administered Therapy at Liver Specialty Clinic (SAT) | Active comparator | Procedure: Self-Administered Therapy (SAT)Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Directly Observed Therapy (mDOT) | Procedure or surgery | Modified Directly Observed Therapy (mDOT) |
| Self-Administered Therapy (SAT) | Procedure or surgery | Self-Administered Therapy at Liver Specialty Clinic (SAT) |
Primary outcome
Number of Participants With a Sustained Virologic Response (SVR)
Time frame: 24 weeks (end of treatment)
SVR is defined as continued undetectable HCV viral load at 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis C
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Douglas Bruce, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Directly Observed Therapy (mDOT) and Self-Administered Therapy (SAT) in people with Hepatitis C and Opiate Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Sustained Virologic Response (SVR) (time frame: 24 weeks (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.