Nicotine DependenceNCT01036711
Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI
An observational study of Nicotine Dependence and Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Many cigarette smokers claim that smoking improves their ability to think and concentrate, and have reported problems in thinking and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Drug Abuse
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2002to 26 Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be between the ages of 18-50.
- Subject must be in good health based on history and physical exams.
- Subjects must be right-handed.
- Smoking subjects must demonstrate that they are experienced users based upon urine cotinine levels of at least 100ng/ml, and must smoke a minimum of 10 cigarettes/day with duration of use of at least 1 year.
- Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence on either substance.
Who cannot join
- Are pregnant or breast feeding. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.
- Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
- Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
- Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
- Have neurological illnesses to including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
- Have significant alcohol or other drug use, other than nicotine dependence.
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- Have gros structural abnormalities onT1 weighted images.
- Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above). Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data.
- Are engaged in or actively seeking smoking cessation treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Background:
- Many cigarette smokers claim that smoking improves their ability to think and concentrate, and have reported problems in thinking and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain s ability to think, pay attention, respond to rewards, and make decisions. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study the effects of nicotine on brain function and activity.
Read more
Objectives:
- To determine the effects of nicotine on attentional and other thinking processes, including reward-seeking behavior.
Eligibility:
- Individuals between 18 and 50 years of age who are either current smokers (10 or more cigarettes per day for at least 1 year) or nonsmokers.
Design:
- The study has four experiments. Each experiment requires two MRI scanning sessions and a training session. Participant can do one or all of the experiments.
- Participants will receive training on the types of computerized tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use, and provide breath and urine samples.
- During the test sessions, participants will have fMRI scanning while performing up to four different sets of tasks that test attention, memory, concentration, reward-seeking behavior, and decision making. Smokers will wear a nicotine patch or placebo patch during the test sessions, but will not be told which patch they are receiving. The order of these sessions will be different for individual participants.
- Participants will provide blood and urine samples throughout the research study for evaluation purposes.
Read the detailed description
Objective:
Experiments in this protocol employ fMRI to address the interactions of nicotine with such cognitive processes as working memory, attention, and the executive functions of inhibitory control, conceptual reasoning and attention switching, in addition to reward and temporal error reward processing. The effects of nicotine on these cognitive processes will also be assessed outside the MRI scanner. Assessments of genetic variants will be done with the hypothesis that these will account for some inter-individual differences in the brain imaging data.
Study Population:
The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers and age and gender matched non-smoking control subjects. The control subjects will provide normative data on cognitive task performance and corresponding neural activation, as well as providing control for any time effects (e.g. practice effect on repeated cognitive task performance). Smokers will smoke at least 10 cigarettes per day for a period of 1 year. Both smokers and controls will be suitable for fMRI scanning. Subjects may not be dependent on any other drug except nicotine or caffeine.
Design:
In a within subjects design, experienced smokers will perform cognitive tasks involving memory encoding and consolidation, selective/divided and sustained attention, as well as reward and temporal error reward processing two hours following single blind application of a nicotine patch (21 mg/24 hr) and during a separate session on a different day, following application of a placebo patch. The tasks will be performed during fMRI scanning. Not all of the tasks will be done at the same time, rather, groups of tasks are run in series as task sets: Task set A: Selective/divided attention task and Intention/ attention task; Task set B: The SARAT (Spatial Attentional Resource Allocation task) which is designed to enable dissociation of top-down and stimulus driven processes of visuospatial selective attention as well as the CEFER task which is a measure of central executive function task which isolates the allocation of attentional resources within working memory; Task set C: Monetary Incentive Delay and Temporal Delay Error processing tasks; Task set D: Affective Forecasting and Loss Aversion task. Control subjects will do the tasks during scanning without a patch. Blood will be drawn from all participants for analysis of genetic variants and for smokers, plasma nicotine and cotinine will be measured.
Outcome:
We will determine the acute effects of nicotine on attentional and other cognitive mechanisms and how emotional processes such as the anticipation and receipt of reward affects the neuronal activation properties of acute nicotine administration in experienced smokers. In addition, we will determine whether genetic polymorphisms predict BOLD response during cognitive tasks pertinent to nicotine addiction. Plasma nicotine and cotinine will be included as a factor in analyses of nicotine-induced effects on fMRI signal to take account of potentially large inter-individual variability in circulating nicotine concentrations.
- Conditions
- Nicotine Dependence, Drug Abuse
- Keywords
- Attention, Working Memory, Central Executive Processes, Response Preparation, Cigarettes
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start17 Sep 2002
- Study completion26 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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
- Time perspective
- Other
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036711
- Sponsor's protocol ID
- 999902372
- Other IDs
- 02-DA-N372
- Status last verified
- 26 Nov 2012
- First submitted
- 18 Dec 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. doi: 10.1002/med.2610020104. No abstract available.
PubMed 6125634Andrews B, Brewin CR, Ochera J, Morton J, Bekerian DA, Davies GM, Mollon P. The timing, triggers and qualities of recovered memories in therapy. Br J Clin Psychol. 2000 Mar;39(1):11-26. doi: 10.1348/014466500163077.
PubMed 10789025Arinami T, Gao M, Hamaguchi H, Toru M. A functional polymorphism in the promoter region of the dopamine D2 receptor gene is associated with schizophrenia. Hum Mol Genet. 1997 Apr;6(4):577-82. doi: 10.1093/hmg/6.4.577.
PubMed 9097961
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI
- ClinicalTrials.gov ID
- NCT01036711
- Acronym / sponsor ID
- 999902372
- Conditions
- Nicotine Dependence, Drug Abuse
- Keywords
- Attention, Working Memory, Central Executive Processes, Response Preparation, Cigarettes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 17 Sep 2002
- Study completion
- 26 Nov 2012
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Many cigarette smokers claim that smoking improves their ability to think and concentrate, and have reported problems in thinking and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain s ability to think, pay attention, respond to rewards, and make decisions. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study the effects of nicotine on brain function and activity.
Objectives:
- To determine the effects of nicotine on attentional and other thinking processes, including reward-seeking behavior.
Eligibility:
- Individuals between 18 and 50 years of age who are either current smokers (10 or more cigarettes per day for at least 1 year) or nonsmokers.
Design:
- The study has four experiments. Each experiment requires two MRI scanning sessions and a training session. Participant can do one or all of the experiments.
- Participants will receive training on the types of computerized tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use, and provide breath and urine samples.
- During the test sessions, participants will have fMRI scanning while performing up to four different sets of tasks that test attention, memory, concentration, reward-seeking behavior, and decision making. Smokers will wear a nicotine patch or placebo patch during the test sessions, but will not be told which patch they are receiving. The order of these sessions will be different for individual participants.
- Participants will provide blood and urine samples throughout the research study for evaluation purposes.
Detailed description
Objective:
Experiments in this protocol employ fMRI to address the interactions of nicotine with such cognitive processes as working memory, attention, and the executive functions of inhibitory control, conceptual reasoning and attention switching, in addition to reward and temporal error reward processing. The effects of nicotine on these cognitive processes will also be assessed outside the MRI scanner. Assessments of genetic variants will be done with the hypothesis that these will account for some inter-individual differences in the brain imaging data.
Study Population:
The study population will consist of adult (18-50 y.o.) non-treatment seeking smokers and age and gender matched non-smoking control subjects. The control subjects will provide normative data on cognitive task performance and corresponding neural activation, as well as providing control for any time effects (e.g. practice effect on repeated cognitive task performance). Smokers will smoke at least 10 cigarettes per day for a period of 1 year. Both smokers and controls will be suitable for fMRI scanning. Subjects may not be dependent on any other drug except nicotine or caffeine.
Design:
In a within subjects design, experienced smokers will perform cognitive tasks involving memory encoding and consolidation, selective/divided and sustained attention, as well as reward and temporal error reward processing two hours following single blind application of a nicotine patch (21 mg/24 hr) and during a separate session on a different day, following application of a placebo patch. The tasks will be performed during fMRI scanning. Not all of the tasks will be done at the same time, rather, groups of tasks are run in series as task sets: Task set A: Selective/divided attention task and Intention/ attention task; Task set B: The SARAT (Spatial Attentional Resource Allocation task) which is designed to enable dissociation of top-down and stimulus driven processes of visuospatial selective attention as well as the CEFER task which is a measure of central executive function task which isolates the allocation of attentional resources within working memory; Task set C: Monetary Incentive Delay and Temporal Delay Error processing tasks; Task set D: Affective Forecasting and Loss Aversion task. Control subjects will do the tasks during scanning without a patch. Blood will be drawn from all participants for analysis of genetic variants and for smokers, plasma nicotine and cotinine will be measured.
Outcome:
We will determine the acute effects of nicotine on attentional and other cognitive mechanisms and how emotional processes such as the anticipation and receipt of reward affects the neuronal activation properties of acute nicotine administration in experienced smokers. In addition, we will determine whether genetic polymorphisms predict BOLD response during cognitive tasks pertinent to nicotine addiction. Plasma nicotine and cotinine will be included as a factor in analyses of nicotine-induced effects on fMRI signal to take account of potentially large inter-individual variability in circulating nicotine concentrations.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (9 listed)
- Are pregnant or breast feeding. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.
- Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
- Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
- Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders.
- Have neurological illnesses to including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 6125634Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. doi: 10.1002/med.2610020104. No abstract available.
- Background: PubMed 10789025Andrews B, Brewin CR, Ochera J, Morton J, Bekerian DA, Davies GM, Mollon P. The timing, triggers and qualities of recovered memories in therapy. Br J Clin Psychol. 2000 Mar;39(1):11-26. doi: 10.1348/014466500163077.
- Background: PubMed 9097961Arinami T, Gao M, Hamaguchi H, Toru M. A functional polymorphism in the promoter region of the dopamine D2 receptor gene is associated with schizophrenia. Hum Mol Genet. 1997 Apr;6(4):577-82. doi: 10.1093/hmg/6.4.577.
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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.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Nicotine Dependence and Drug Abuse, run by National Institute on Drug Abuse (NIDA) 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 5 inclusion and 9 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 5 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036711, which also lists 3 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 5 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.