- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915798
Association Between Smoking, Brain Activity, Genes, and ADHD
January 12, 2017 updated by: Jean Gehricke, University of California, Irvine
Smoking, Neurocircuitry and Genes in Adult 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Santa Ana, California, United States, 92705
- 2500 Red Hill Avenue
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Commuity sample
Description
Inclusion Criteria:
Smokers with ADHD
- Cigarette smoking for the last year
- ADHD diagnosis
Nonsmokers with ADHD
- No history of regularly smoking cigarettes
- ADHD diagnosis
Normative control smokers
- Cigarette smoking for the last year
- No history and diagnosis of ADHD
Normative control nonsmokers
- No history of regularly smoking cigarettes
- No history and diagnosis of ADHD
Exclusion Criteria:
- Children under the age of 18
- Adults above the age of 45
- Pregnancy or planning to become pregnant
- Any major medical illness
- Any mental disorders that require medication (except stimulant medication)
- Any contraindications to fMRI scanning
- Not speaking English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Smokers with ADHD
Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
|
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.
|
|
Nonsmokers with ADHD
Nonsmokers with ADHD participated in one condition.
|
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
|
|
Control smokers
Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).
|
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.
|
|
Control nonsmokers
Control nonsmokers participated in one condition.
|
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain Activity
Time Frame: One MRI session for nonsmokers and two MRI sessions for smokers
|
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.
|
One MRI session for nonsmokers and two MRI sessions for smokers
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DRD4 Genotype
Time Frame: one time blood draw
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one time blood draw
|
|
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Salivary Cotinine
Time Frame: Once per week for 4 weeks
|
Average level of salivary cotinine over all time points (microgram/milliliter)
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Once per week for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-G. Gehricke, Ph.D., M.A., University of California, Irvine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gehricke JG, Swanson JM, Duong S, Nguyen J, Wigal TL, Fallon J, Caburian C, Muftuler LT, Moyzis RK. Increased brain activity to unpleasant stimuli in individuals with the 7R allele of the DRD4 gene. Psychiatry Res. 2015 Jan 30;231(1):58-63. doi: 10.1016/j.pscychresns.2014.10.021. Epub 2014 Nov 4.
- Gehricke JG, Gevorkian J, Stehli A, Alejo SD, Dawson M, Kopelevich A. Discrepancies in the Validity of Self-Reported Cigarette Smoking in Adults With and Without ADHD. J Dual Diagn. 2019 Jul-Sep;15(3):177-183. doi: 10.1080/15504263.2019.1620399. Epub 2019 Jun 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 4, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 8, 2009
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- HS 2009-6740
- K01DA025131 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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