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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: Completed Phase 2 study, sponsored by Yale University.
NCT00577005 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome variable was the change from baseline to week 13 of the thrice weekly cocaine-free urine scores. In this repeated ordinal variable, 0 represented all 3 urine samples submitted by the subject as positives, 1 represented some urine samples submitted by the subject were negative, and 2 represented all 3 urine samples submitted by the subjects were negative for cocaine. Balancing the distribution between these categories improved the models for the analysis of repeated ordinal da
Interventions
- DRUG Placebo
- DRUG levetiracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00577005 record still lists
NCT00577005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00577005 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00577005's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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