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NCT01601730 · ClinicalTrials.gov registry record · Phase 1
Modafinil - Escitalopram Study for Cocaine Dependence
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01601730: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01601730 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601730, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.
Primary Outcome
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on modafinil and/or escitalopram relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and
Interventions
- DRUG Placebo
- DRUG Escitalopram
- DRUG Modafinil
- DRUG Modafinil and Escitalopram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01601730 record still lists
NCT01601730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01601730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01601730 about?
NCT01601730 is a clinical study titled "Modafinil - Escitalopram Study for Cocaine Dependence". The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.
What is the current status of trial NCT01601730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2010-08. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01601730?
The interventions under investigation include: Placebo (DRUG), Escitalopram (DRUG), Modafinil (DRUG), Modafinil and Escitalopram (DRUG).
Who is sponsoring clinical trial NCT01601730?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01601730's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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