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NCT00577005 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT00577005 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 28 participants.

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The verdict

NCT00577005, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medications both in and outside of these methadone programs. We have initial data from our open-label study with levetiracetam showing that this medication is well tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population. The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients. The primary outcomes will be reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention) and change in measures of cocaine craving, anxiety symptoms and opiate withdrawal symptoms.

Interventions

  • DRUG Placebo
  • DRUG levetiracetam

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2007-07
Est. Completion 2008-10
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT00577005

The ClinicalTrials.gov registry entry for NCT00577005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00577005 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00577005 about?

NCT00577005 is a clinical study titled "Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients". Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medication...

What is the current status of trial NCT00577005?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2007-07. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00577005?

The interventions under investigation include: Placebo (DRUG), levetiracetam (DRUG).

Who is sponsoring clinical trial NCT00577005?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.