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NCT01437293 · ClinicalTrials.gov registry record · Phase 1
Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)
A Phase 1 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01437293: Completed Phase 1 study, sponsored by New York State Psychiatric Institute.
NCT01437293 is a Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437293, a Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked cocaine with ascending doses.
Primary Outcome
Maximum SBP, maximum DPB will be obtained at baseline, prior to the first session dose, and after each consecutive dose (0, 6, 12, 25, 50, 50 mg). Changes from baseline in blood pressure in the used by cocaine administration under placebo condition will be compared to those obtained during treatment with LCE using repeated measures ANOVA.
Interventions
- DRUG L-dopa / carbidopa / entacapone (LCE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01437293 record still lists
NCT01437293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which L-dopa / carbidopa / entacapone (LCE) is the first listed.
NCT01437293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437293 about?
NCT01437293 is a clinical study titled "Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)". An inpatient safety study to characterize the cardiovascular and behavioral effects of cocaine administration in the presence of LCE. The proposed study involves an inpatient stay of 12 days during which participants will have two cocaine-administration sessions, each including five doses of smoked ...
What is the current status of trial NCT01437293?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-08. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01437293?
The interventions under investigation include: L-dopa / carbidopa / entacapone (LCE) (DRUG).
Who is sponsoring clinical trial NCT01437293?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01437293's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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