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Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
NCT00553319 · View on ClinicalTrials.gov ↗
Study Summary
The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Adderall-XR
Study Locations (2)
Minnesota
- Ambulatory Research Center/Fairview University Psychiatry Dept — Minneapolis
New York
- STARS — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2007-12 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00553319
The ClinicalTrials.gov registry entry for NCT00553319 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 139 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 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cocaine Dependence appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00553319 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00553319 about?
NCT00553319 is a clinical study titled "Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence". The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are propo...
What is the current status of trial NCT00553319?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2007-12. Estimated completion is 2013-07.
What conditions does trial NCT00553319 study?
This clinical trial studies the following conditions: Cocaine Dependence, Adult Attention Deficit Hyperactivity Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00553319?
The interventions under investigation include: Placebo (DRUG), Adderall-XR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00553319?
This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00553319 being conducted?
This trial has 2 study locations across Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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