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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗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.
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