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NCT00223236 · ClinicalTrials.gov registry record · Phase 3
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT00223236: Completed Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
NCT00223236 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223236, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.
Primary Outcome
Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectivel
Interventions
- DRUG Placebo
- DRUG Citicoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00223236 record still lists
NCT00223236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00223236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00223236 about?
NCT00223236 is a clinical study titled "Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence". The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturba...
What is the current status of trial NCT00223236?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2010-07. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00223236?
The interventions under investigation include: Placebo (DRUG), Citicoline (DRUG).
Who is sponsoring clinical trial NCT00223236?
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 NCT00223236's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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