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NCT00240110 · ClinicalTrials.gov registry record · Phase 1
Valproate Efficacy in Cocaine-Bipolar Comorbidity
A Phase 1 study of Bipolar Disorder and Cocaine Dependence, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 152
- Enrollment target
- 2
- Study locations
NCT00240110: Completed Phase 1 study of Bipolar Disorder and Cocaine Dependence, sponsored by University of Miami.
NCT00240110 is a Phase 1 study of Bipolar Disorder and Cocaine Dependence that has completed, run by University of Miami. The registered enrollment target is 152 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00240110, a Phase 1 study of Bipolar Disorder and Cocaine Dependence, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 152 participants
- Enrollment target
- 2
- Study locations
Study Summary
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.
Primary Outcome
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Valproate
- DRUG Lithium Carbonate
Study Locations (2)
Florida
- University of Miami Miller School of Medicine, Department of Psychiatry - Miami
- University of Miami Miller School of Medicine - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2006-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT00240110 record still lists
NCT00240110 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00240110 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00240110 about?
NCT00240110 is a clinical study titled "Valproate Efficacy in Cocaine-Bipolar Comorbidity". This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual co...
What is the current status of trial NCT00240110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2006-03. Estimated completion is 2014-03.
What conditions does trial NCT00240110 study?
This clinical trial studies the following conditions: Bipolar Disorder, Cocaine Dependence.
What interventions are being tested in trial NCT00240110?
The interventions under investigation include: Placebo (DRUG), Valproate (DRUG), Lithium Carbonate (DRUG).
Who is sponsoring clinical trial NCT00240110?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00240110 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00240110's enrollment target sits among peer trials
152 46th of 162 higher than 117 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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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