Trial Outcomes & Findings for Association Between Smoking, Brain Activity, Genes, and ADHD (NCT NCT00915798)
NCT ID: NCT00915798
Last Updated: 2017-01-13
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
89 participants
Primary outcome timeframe
One MRI session for nonsmokers and two MRI sessions for smokers
Results posted on
2017-01-13
Participant Flow
Smokers and nonsmokers with and without ADHD
Participant milestones
| Measure |
Smokers With ADHD
Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal).
|
Nonsmokers With ADHD
Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
|
Control Smokers
Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal).
|
Control Nonsmokers
Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
23
|
26
|
|
Overall Study
COMPLETED
|
19
|
21
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Association Between Smoking, Brain Activity, Genes, and ADHD
Baseline characteristics by cohort
| Measure |
ADHD Smokers
n=19 Participants
ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
|
ADHD Nonsmokers
n=21 Participants
ADHD nonsmokers participated in the abstinence condition.
|
Control Smokers
n=23 Participants
Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
|
Control Nonsmokers
n=26 Participants
Control nonsmokers participated in the abstinence condition.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
23.00 years
STANDARD_DEVIATION 1.70 • n=5 Participants
|
27.24 years
STANDARD_DEVIATION 7.96 • n=7 Participants
|
25.04 years
STANDARD_DEVIATION 4.29 • n=5 Participants
|
22.69 years
STANDARD_DEVIATION 1.85 • n=4 Participants
|
24.44 years
STANDARD_DEVIATION 4.88 • n=21 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One MRI session for nonsmokers and two MRI sessions for smokersPopulation: Discrepancies between participant flow and number of participants analyzed are due to motion artifacts, which compromised the MRI findings. Thus, a number of participants had to be excluded from the MRI data analysis.
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.
Outcome measures
| Measure |
Smokers With ADHD After Abstinence
n=13 Participants
Smokers with ADHD after overnight abstinence (withdrawal).
|
Nonsmokers With ADHD
n=14 Participants
Nonsmokers participate in one condition.
|
Control Smokers After Abstinence
n=19 Participants
Control smokers after overnight abstinence (withdrawal).
|
Control Nonsmokers
n=21 Participants
Nonsmokers participate in one condition.
|
Smokers With ADHD After Smoking
n=13 Participants
Smokers with ADHD after smoking the first cigarette of the day
|
Control Smokers After Smoking
n=19 Participants
Control smokers after smoking the first cigarette of the day
|
|---|---|---|---|---|---|---|
|
Brain Activity
BOLD Frontal Lobe
|
2.08 z-score
Standard Deviation 0.23
|
2.01 z-score
Standard Deviation 0.63
|
2.24 z-score
Standard Deviation 0.18
|
2.30 z-score
Standard Deviation 0.20
|
2.19 z-score
Standard Deviation 0.25
|
2.26 z-score
Standard Deviation 0.23
|
|
Brain Activity
BOLD Parietal Lobe
|
2.69 z-score
Standard Deviation 0.53
|
2.30 z-score
Standard Deviation 0.37
|
2.48 z-score
Standard Deviation 0.37
|
2.77 z-score
Standard Deviation 0.71
|
2.61 z-score
Standard Deviation 0.72
|
2.60 z-score
Standard Deviation 0.70
|
|
Brain Activity
BOLD Occipital Lobe
|
2.72 z-score
Standard Deviation 0.47
|
2.87 z-score
Standard Deviation 0.74
|
2.71 z-score
Standard Deviation 0.61
|
2.88 z-score
Standard Deviation 0.49
|
2.80 z-score
Standard Deviation 0.75
|
2.90 z-score
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: one time blood drawPopulation: Discrepancies between participant flow and data analyze reflect that not all participants provided blood samples. Dopamine genotypes were only available for participants who were also enrolled in the Multimodal Treatment for ADHD Study (MTA-Study).
Outcome measures
| Measure |
Smokers With ADHD After Abstinence
n=10 Participants
Smokers with ADHD after overnight abstinence (withdrawal).
|
Nonsmokers With ADHD
n=7 Participants
Nonsmokers participate in one condition.
|
Control Smokers After Abstinence
n=5 Participants
Control smokers after overnight abstinence (withdrawal).
|
Control Nonsmokers
n=18 Participants
Nonsmokers participate in one condition.
|
Smokers With ADHD After Smoking
Smokers with ADHD after smoking the first cigarette of the day
|
Control Smokers After Smoking
Control smokers after smoking the first cigarette of the day
|
|---|---|---|---|---|---|---|
|
DRD4 Genotype
DRD4-4R/7R
|
1 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
—
|
—
|
|
DRD4 Genotype
DRD4-4R/4R
|
5 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
DRD4 Genotype
DRD4-3R/4R
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
DRD4 Genotype
DRD4-3R/3R
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
DRD4 Genotype
DRD4-2R/4R
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
DRD4 Genotype
DRD4-2R/2R
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Once per week for 4 weeksPopulation: Discrepancies between participants cotinine samples and participant flow are due to the fact that not all participants provided useful saliva samples.
Average level of salivary cotinine over all time points (microgram/milliliter)
Outcome measures
| Measure |
Smokers With ADHD After Abstinence
n=19 Participants
Smokers with ADHD after overnight abstinence (withdrawal).
|
Nonsmokers With ADHD
n=14 Participants
Nonsmokers participate in one condition.
|
Control Smokers After Abstinence
n=20 Participants
Control smokers after overnight abstinence (withdrawal).
|
Control Nonsmokers
n=26 Participants
Nonsmokers participate in one condition.
|
Smokers With ADHD After Smoking
Smokers with ADHD after smoking the first cigarette of the day
|
Control Smokers After Smoking
Control smokers after smoking the first cigarette of the day
|
|---|---|---|---|---|---|---|
|
Salivary Cotinine
|
100.06 Microgram/milliliter
Standard Deviation 111.52
|
24.53 Microgram/milliliter
Standard Deviation 86.66
|
104.99 Microgram/milliliter
Standard Deviation 84.75
|
23.13 Microgram/milliliter
Standard Deviation 52.65
|
—
|
—
|
Adverse Events
Smokers With ADHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nonsmokers With ADHD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Nonsmokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place