Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI
2 other identifiers
observational
249
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2002
CompletedFirst Submitted
Initial submission to the registry
December 18, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2012
CompletedApril 5, 2018
November 26, 2012
December 18, 2009
April 4, 2018
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224, United States
Related Publications (3)
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.
PMID: 6125634BACKGROUNDAndrews 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.
PMID: 10789025BACKGROUNDArinami 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.
PMID: 9097961BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elliot Stein, Ph.D.
National Institute on Drug Abuse (NIDA)
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 18, 2009
First Posted
December 21, 2009
Study Start
September 17, 2002
Study Completion
November 26, 2012
Last Updated
April 5, 2018
Record last verified: 2012-11-26