An interventional study of Modified Directly Observed Therapy (mDOT) and Self-Administered Therapy (SAT) in Hepatitis C and Opiate Dependence, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-03.
Sponsored by Yale University · Not applicable, Interventional, and Health services research
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hepatitis C Virus (HCV) Treatment in Modified Directly Observed Therapy (mDOT) in Methadone Maintenance Treatment (MMT)
Procedure: Modified Directly Observed Therapy (mDOT)
Hepatitis C virus (HCV) at a liver specialty clinic as self-administered therapy
Procedure: Self-Administered Therapy (SAT)
Number of Participants With a Sustained Virologic Response (SVR)
SVR is defined as continued undetectable HCV viral load at 24 weeks
Time frame: 24 weeks (end of treatment)
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.
| Milestone | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) |
|---|---|---|
| Started | 12 | 9 |
| Completed | 11 | 2 |
| Not completed | 1 | 7 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Incarceration | 0 | 2 |
| Withdrew: Homeless--no refrigeration for meds | 0 | 1 |
| Withdrew: Not comfortable with self-injecting | 0 | 1 |
| Withdrew: Mental health--depression | 0 | 1 |
| Withdrew: Couldn't tolerate side-effects | 1 | 1 |
SVR is defined as continued undetectable HCV viral load at 24 weeks
| participants | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) |
|---|---|---|
| Number of Participants With a Sustained Virologic Response (SVR) | 7 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modified Directly Observed Therapy (mDOT) | — | 0/12 (0%) | 0/12 (0%) |
| Self-Administered Therapy (SAT) | — | 0/9 (0%) | 0/9 (0%) |
| Age Continuous(years) | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) | Total |
|---|---|---|---|
| Mean | 40 (29 to 51) | 43 (36 to 54) | 42 (29 to 54) |
| Sex: Female, Male(Participants) | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 5 | 6 | 11 |
| Region of Enrollment(participants) | Modified Directly Observed Therapy (mDOT) | Self-Administered Therapy (SAT) | Total |
|---|---|---|---|
| United States | 12 | 9 | 21 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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