SmokingNCT00915798
Association Between Smoking, Brain Activity, Genes, and ADHD
An observational study of Smoking and Withdrawal Nicotine, run by University of California, Irvine at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Withdrawal Nicotine, ADHD
- What is being tested?
- Cigarette smoking and Abstinence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Commuity sample
Who may be able to join
- Smokers with ADHD
- Cigarette smoking for the last year
- ADHD diagnosis
- Nonsmokers with ADHD
- No history of regularly smoking cigarettes
- ADHD diagnosis
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Smoking, Withdrawal Nicotine, ADHD
- Being tested
- Cigarette smoking, Abstinence
- Medical subject headings
- Smoking, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette smokingBehavioural
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.
AbstinenceBehavioural
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Smokers with ADHD | Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning). Receives: Behavioral: Cigarette smoking; Behavioral: Abstinence | |
| Nonsmokers with ADHD | Nonsmokers with ADHD participated in one condition. Receives: Behavioral: Abstinence | |
| Control smokers | Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning). Receives: Behavioral: Cigarette smoking; Behavioral: Abstinence | |
| Control nonsmokers | Control nonsmokers participated in one condition. Receives: Behavioral: Abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One MRI session for nonsmokers and two MRI sessions for smokers
Secondary outcomes (2)
DRD4 Genotype
Measured: one time blood draw
Salivary Cotinine
Average level of salivary cotinine over all time points (microgram/milliliter)
Measured: Once per week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jean Gehricke, University of California, Irvine
- Investigators
- Jean-G. Gehricke, Ph.D., M.A., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915798
- Sponsor's protocol ID
- HS 2009-6740
- Other IDs
- K01DA025131
- Status last verified
- Nov 2016
- First submitted
- 4 Jun 2009
- Last updated
- 13 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 25481571Gehricke 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.
PubMed 31156069
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking, Neurocircuitry and Genes in Adult ADHD
- ClinicalTrials.gov ID
- NCT00915798
- Acronym / sponsor ID
- HS 2009-6740
- Conditions
- Smoking, Withdrawal Nicotine, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 13 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smokers with ADHD | – | Behavioral: Cigarette smoking, Behavioral: AbstinenceSmokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning). |
| Nonsmokers with ADHD | – | Behavioral: AbstinenceNonsmokers with ADHD participated in one condition. |
| Control smokers | – | Behavioral: Cigarette smoking, Behavioral: AbstinenceControl smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning). |
| Control nonsmokers | – | Behavioral: AbstinenceControl nonsmokers participated in one condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Commuity sample
Key inclusion criteria (12 listed)
- Smokers with ADHD
- Nonsmokers with ADHD
- Normative control smokers
- Normative control nonsmokers
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarette smokingParticipants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette. | Behavioural | Control smokers, Smokers with ADHD |
| AbstinenceParticipants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence. | Behavioural | Control nonsmokers, Control smokers, Nonsmokers with ADHD, Smokers with ADHD |
Primary outcome
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.
2 secondary outcomes
DRD4 Genotype
Time frame: one time blood draw
Salivary Cotinine
Time frame: Once per week for 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25481571Gehricke 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.
- Derived from this study: PubMed 31156069Gehricke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-G. Gehricke, Ph.D., M.A. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Withdrawal Nicotine, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Activity (time frame: One MRI session for nonsmokers and two MRI sessions for smokers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.