An observational study in Smoking and ADHD, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by Duke University · Observational
The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.
Study Hypotheses:
Individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) smoke more than the general population, initiate use at a younger age, and report more difficulty trying to quit. The overarching goal of the present application is to use neuroimaging, neuropharmacological and molecular genetic techniques to study the neurobiological basis of abstinence-induced deficits in response inhibition in ADHD and non-ADHD smokers. Twenty smokers with ADHD and 20 smokers without ADHD will undergo imaging during a Go/No-Go task under the following conditions: 1) smoking as usual, 2) 24 hr smoking abstinence, and 3) 24 hr smoking abstinence + methylphenidate (MPH). We hypothesize that compared to smoking as usual, 24 hr smoking abstinence will result in decrements in response inhibition and disruption of task-related brain activation. These effects will be greater in ADHD as compared to non-ADHD smokers. We further hypothesize that MPH administration during abstinence will restore performance and brain indices of response inhibition and that the magnitude of the effect of MPH will be greater among smokers with ADHD. In addition to the above aims, we will preliminarily evaluate the moderating effects of the dopamine receptor D4 7-repeat allele on task-related brain activation following smoking abstinence and MPH administration.
During the study, 101 subjects signed consents and 38 subjects completed the study.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 101 is below the median of 127 across 267 observational studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
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120 voluntary participants to yield 40 Adult Regular Smokers, including 20 diagnosed with ADHD and 20 comparison controls.
Exclusion Criteria:
Those that are defined as regular smokers (10 cigarettes/day or Carbon Monoxide reading of 10 ppm). The group will then be split into those diagnosed with ADHD/ADD and controls for comparison.
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.
Smokers will undergo three functional Magnetic Resonance Image scanning sessions while performing a task that measures response inhibition (Go/Go/No-Go task) Scanning will take place in the following conditions: smoking as usual + placebo pill, 24 hr smoking abstinence + placebo pill and 24 hr abstinence + methylphenidate (MPH). Methylphenidate is a dopamine reuptake inhibitor and its administration will allow us to evaluate the role of dopamine neurotransmission on response inhibition in the context of smoking abstinence.
Time frame: July 2009 through December 2013
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Duke University