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NCT01535937 · ClinicalTrials.gov registry record · Phase 1
The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
A Phase 1 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01535937: Clinical Trial Phase 1 study, sponsored by New York State Psychiatric Institute.
NCT01535937 is a Phase 1 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01535937, a Phase 1 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.
Primary Outcome
Number of participants who use cocaine and drop from study. During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.
Interventions
- DRUG Ketamine
- DRUG Midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-02 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
Why NCT01535937 stopped before completion
NCT01535937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT01535937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01535937 about?
NCT01535937 is a clinical study titled "The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence". This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient an...
What is the current status of trial NCT01535937?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2012-02. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01535937?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG).
Who is sponsoring clinical trial NCT01535937?
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 NCT01535937's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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