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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: Completed NA study, sponsored by Duke University.
NCT00736255 is a NA study that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels \<= 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.
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 |
What the finished NCT00736255 record still lists
NCT00736255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00736255 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00736255's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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