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NCT00736255 · ClinicalTrials.gov registry record · NA

Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
32
Enrollment target

NCT00736255 is a NA study that has completed, run by Duke University. The registered enrollment target is 32 participants.

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The verdict

NCT00736255, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target

Study Summary

The overall goal of the present project is to investigate whether lisdexamphetamine (LDX; Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and nicotine dependence. The investigators hypothesized initially that smokers with ADHD who are optimized to a dose of LDX prior to quitting smoking and who remain on this dose of medication after quitting will remain abstinent longer than patients who are treated with placebo before and after quitting.However due to recent key issues that have arisen showing that initiation of stimulant treatment while subjects are actively smoking may facilitate increased smoking, and given that the study was still in the very early stage of study execution, the investigators revised the study design to use an empirically validated pretreatment approach with NRT and to initiate LDX treatment on the first post quit date in order to reduce the withdrawal symptoms that accompany smoking cessation. The overall rationale for this revised study design remains similar to the original.

Interventions

  • DRUG Placebo
  • DRUG Transdermal Nicotine Patch
  • DRUG Lis-dexamphetamine (Vyvanse)

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2007-12
Est. Completion 2011-07
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT00736255

The ClinicalTrials.gov registry entry for NCT00736255 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00736255 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00736255 about?

NCT00736255 is a clinical study titled "Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study". The overall goal of the present project is to investigate whether lisdexamphetamine (LDX; Vyvanse) is an effective adjunct to nicotine replacement therapy (NRT) to promote smoking cessation in patients with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and nicotine dependence. The investi...

What is the current status of trial NCT00736255?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2007-12. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00736255?

The interventions under investigation include: Placebo (DRUG), Transdermal Nicotine Patch (DRUG), Lis-dexamphetamine (Vyvanse) (DRUG).

Who is sponsoring clinical trial NCT00736255?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.