View Clinical Trial (Medical Research Study)
Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence
| City: |
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Durham |
| State: |
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North Carolina |
| Zip Code: |
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27705 |
| Conditions: |
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Smoking - ADHD |
| Purpose: |
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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:
1. compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced
decrements in response inhibition performance and reward and greater concomitant
disruptions of brain activity
2. administration of MPH to abstinent smokers will ameliorate response inhibition
performance and reward deficits and task-related brain activation and this effect will
be greater among ADHD smokers
3. genetic markers of dopamine neurotransmission will moderate abstinence- and MPH -
induced changes in task-related brain activation across tasks.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. generally healthy, between the ages of 18-50yrs,
2. smoking at least 10 cigarettes/day of a brand delivering ≥0.5 mg nicotine according
to the standard Federal Trade Commission (FTC) method,
3. an expired Carbon Monoxide concentration of at least 10ppm (to confirm inhalation) or
a positive urine cotinine test (Nicalert ™) of 3 or greater,
4. no interest in quitting smoking as measured by self-report,
5. right-handed as measured by a three item scale used in our laboratory.
Exclusion Criteria:
1. unable to attend all required experimental sessions,
2. have significant health problems (e.g., chronic hypertension, emphysema, seizure
disorders, history of significant heart problems),
3. use of psychoactive medications with the exception of ADHD pharmacotherapies among
ADHD diagnosed participants (see washout procedures below)
4. use of smokeless tobacco
5. current or past year alcohol or drug abuse,
6. use of illegal drugs as measured by urine drug screen or self report
7. current use of nicotine replacement therapy or other smoking cessation treatment,
8. presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in
the body, IUD),
9. if they are female and pregnant or plan on becoming pregnant.
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| NCT ID: |
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NCT01123668 |
| Primary Contact: |
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Principal Investigator
Francis J McClernon, Ph.D.
Duke University Health System
Joseph S English, M.Env.Mgmt.
Phone: 919-681-0028
Email: engli009@mc.duke.edu
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| Backup Contact: |
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Email: matt.hallyburton@dm.duke.edu
Matthew B Hallyburton, B.A.
Phone: 919-684-4676
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| Location Contact: |
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Durham, North Carolina 27705
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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