An observational study in Smoking, Withdrawal Nicotine and ADHD, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by University of California, Irvine · Observational
The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD).
The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD). Four groups of young adults were recruited: (1) smokers with ADHD; (2) nonsmokers with ADHD; (3) normative control smokers; and (4) normative control nonsmokers. Smoking was assessed via questionnaires and salivary cotinine levels. Brain activity was examined via functional Magnetic Resonance Imaging (fMRI). Each nonsmoker underwent an fMRI scan during an experimental task consisting of mathematical problems. Smokers underwent two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence. The association between the DRD4-7 repeat allele and smoking was explored.
University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Commuity sample
Smokers with ADHD
Nonsmokers with ADHD
Normative control smokers
Normative control nonsmokers
Exclusion Criteria:
Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Behavioral: Cigarette smoking · Behavioral: Abstinence
Nonsmokers with ADHD participated in one condition.
Behavioral: Abstinence
Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Behavioral: Cigarette smoking · Behavioral: Abstinence
Control nonsmokers participated in one condition.
Behavioral: Abstinence
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
Brain Activity
BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.
Time frame: One MRI session for nonsmokers and two MRI sessions for smokers
DRD4 Genotype
Time frame: one time blood draw
Salivary Cotinine
Average level of salivary cotinine over all time points (microgram/milliliter)
Time frame: Once per week for 4 weeks
Smokers and nonsmokers with and without ADHD
| Milestone | Smokers With ADHD | Nonsmokers With ADHD | Control Smokers | Control Nonsmokers |
|---|---|---|---|---|
| Started | 19 | 21 | 23 | 26 |
| Completed | 19 | 21 | 23 | 26 |
| Not completed | 0 | 0 | 0 | 0 |
BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.
| z-score | Smokers With ADHD After Abstinence | Nonsmokers With ADHD | Control Smokers After Abstinence | Control Nonsmokers | Smokers With ADHD After Smoking | Control Smokers After Smoking |
|---|---|---|---|---|---|---|
| BOLD Frontal Lobe | 2.08 ± 0.23 | 2.01 ± 0.63 | 2.24 ± 0.18 | 2.30 ± 0.20 | 2.19 ± 0.25 | 2.26 ± 0.23 |
| BOLD Parietal Lobe | 2.69 ± 0.53 | 2.30 ± 0.37 | 2.48 ± 0.37 | 2.77 ± 0.71 | 2.61 ± 0.72 | 2.60 ± 0.70 |
| BOLD Occipital Lobe | 2.72 ± 0.47 | 2.87 ± 0.74 | 2.71 ± 0.61 | 2.88 ± 0.49 | 2.80 ± 0.75 | 2.90 ± 0.80 |
| Participants | Smokers With ADHD | Nonsmokers With ADHD | Control Smokers | Control Nonsmokers |
|---|---|---|---|---|
| DRD4-4R/7R | 1 | 5 | 2 | 10 |
| DRD4-4R/4R | 5 | 1 | 3 | 7 |
| DRD4-3R/4R | 1 | 0 | 0 | 0 |
| DRD4-3R/3R | 1 | 0 | 0 | 0 |
| DRD4-2R/4R | 2 | 0 | 0 | 1 |
| DRD4-2R/2R | 0 | 1 | 0 | 0 |
Average level of salivary cotinine over all time points (microgram/milliliter)
| Microgram/milliliter | ADHD Smokers | ADHD Nonsmokers | Control Smokers | Control Nonsmokers |
|---|---|---|---|---|
| Salivary Cotinine | 100.06 ± 111.52 | 24.53 ± 86.66 | 104.99 ± 84.75 | 23.13 ± 52.65 |
Collected over Up to 6 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Smokers With ADHD | — | 0/19 (0%) | 0/19 (0%) |
| Nonsmokers With ADHD | — | 0/21 (0%) | 0/21 (0%) |
| Control Smokers | — | 0/23 (0%) | 0/23 (0%) |
| Control Nonsmokers | — | 0/26 (0%) | 0/26 (0%) |
| Age, Continuous(years) | ADHD Smokers | ADHD Nonsmokers | Control Smokers | Control Nonsmokers | Total |
|---|---|---|---|---|---|
| Mean | 23.00 ± 1.70 | 27.24 ± 7.96 | 25.04 ± 4.29 | 22.69 ± 1.85 | 24.44 ± 4.88 |
| Gender(Participants) | ADHD Smokers | ADHD Nonsmokers | Control Smokers | Control Nonsmokers | Total |
|---|---|---|---|---|---|
| Female | 2 | 6 | 4 | 18 | 30 |
| Male | 17 | 15 | 19 | 8 | 59 |
| Region of Enrollment(Participants) | ADHD Smokers | ADHD Nonsmokers | Control Smokers | Control Nonsmokers | Total |
|---|---|---|---|---|---|
| United States | 19 | 21 | 23 | 26 | 89 |
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University of California, Irvine