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NCT01468012 · ClinicalTrials.gov registry record · Phase 2
Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01468012: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT01468012 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468012, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.
Primary Outcome
Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation
Interventions
- DRUG Placebo
- DRUG levodopa carbidopa and entacapone (LCE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01468012 record still lists
NCT01468012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01468012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468012 about?
NCT01468012 is a clinical study titled "Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence". The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa...
What is the current status of trial NCT01468012?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2014-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01468012?
The interventions under investigation include: Placebo (DRUG), levodopa carbidopa and entacapone (LCE) (DRUG).
Who is sponsoring clinical trial NCT01468012?
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 NCT01468012's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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