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NCT00553319 · ClinicalTrials.gov registry record · Phase 2
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
A Phase 2 study of Cocaine Dependence and Adult Attention Deficit Hyperactivity Disorder, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
- 2
- Study locations
NCT00553319: Completed Phase 2 study of Cocaine Dependence and Adult Attention Deficit Hyperactivity Disorder, sponsored by New York State Psychiatric Institute.
NCT00553319 is a Phase 2 study of Cocaine Dependence and Adult Attention Deficit Hyperactivity Disorder that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 139 participants, below the 295-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553319, a Phase 2 study of Cocaine Dependence and Adult Attention Deficit Hyperactivity Disorder, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE \<300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.
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 |
What the finished NCT00553319 record still lists
NCT00553319 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 295-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (53% lower).
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.
NCT00553319 reports a single indexed study location in Minnesota, New York.
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.
What interventions are being tested in trial NCT00553319?
The interventions under investigation include: Placebo (DRUG), Adderall-XR (DRUG).
Who is sponsoring clinical trial NCT00553319?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00553319's enrollment target sits among peer trials
139 14th of 38 higher than 25 of 38 other Cocaine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Dependence 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.
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