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NCT00280293 · ClinicalTrials.gov registry record · Phase 4
Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 112
- Enrollment target
NCT00280293: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT00280293 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00280293, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if lamotrigine add-on therapy is associated with decreased cocaine craving and improvement in depressive symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and the improvement of manic symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence.
Primary Outcome
Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.
Interventions
- DRUG Placebo
- DRUG Lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
What the finished NCT00280293 record still lists
NCT00280293 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00280293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00280293 about?
NCT00280293 is a clinical study titled "Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency". The purpose of this study is to determine if lamotrigine add-on therapy is associated with decreased cocaine craving and improvement in depressive symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study is examining whether lamot...
What is the current status of trial NCT00280293?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2006-03. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00280293?
The interventions under investigation include: Placebo (DRUG), Lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00280293?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00280293's enrollment target sits among peer trials
112 724th of 2000 higher than 1,275 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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