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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 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.

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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.

Conditions Studied

Cocaine Dependence Adult Attention Deficit Hyperactivity Disorder

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

FieldValue
Enrollment Target 139 participants
Start Date 2007-12
Est. Completion 2013-07
Phase Phase 2

Sponsor

New York State Psychiatric Institute

364 total trials

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What the Registry Record Tells You About NCT00553319

The ClinicalTrials.gov registry entry for NCT00553319 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 295-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (53% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.