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NCT00633243 · ClinicalTrials.gov registry record · NA

Effective Treatment of Hepatitis C in Substance Users

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT00633243: Completed NA study, sponsored by Yale University.

NCT00633243 is a NA study that has completed, run by Yale University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00633243, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study 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.

Primary Outcome

SVR is defined as continued undetectable HCV viral load at 24 weeks

Interventions

  • PROCEDURE Modified Directly Observed Therapy (mDOT)
  • PROCEDURE Self-Administered Therapy (SAT)

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2007-04
Est. Completion 2011-09
Phase NA
Yale University

1,492 total trials

What the finished NCT00633243 record still lists

NCT00633243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Modified Directly Observed Therapy (mDOT) is the first listed.

NCT00633243 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00633243 about?

NCT00633243 is a clinical study titled "Effective Treatment of Hepatitis C in Substance Users". 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. Th...

What is the current status of trial NCT00633243?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2007-04. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00633243?

The interventions under investigation include: Modified Directly Observed Therapy (mDOT) (PROCEDURE), Self-Administered Therapy (SAT) (PROCEDURE).

Who is sponsoring clinical trial NCT00633243?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00633243's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00633243, the US trial registry maintained by the National Library of Medicine. NCT00633243 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.