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NCT00421603 · ClinicalTrials.gov registry record · Phase 2
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT00421603 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 81 participants.
The verdict
NCT00421603, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.
Interventions
- DRUG Placebo
- DRUG Adderall-XR and Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00421603
The ClinicalTrials.gov registry entry for NCT00421603 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00421603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00421603 about?
NCT00421603 is a clinical study titled "A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence". The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that ...
What is the current status of trial NCT00421603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2007-02. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00421603?
The interventions under investigation include: Placebo (DRUG), Adderall-XR and Topiramate (DRUG).
Who is sponsoring clinical trial NCT00421603?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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