NCT01036711

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2002

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2012

Completed
Last Updated

April 5, 2018

Status Verified

November 26, 2012

First QC Date

December 18, 2009

Last Update Submit

April 4, 2018

Conditions

Keywords

AttentionWorking MemoryCentral Executive ProcessesResponse PreparationCigarettes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 6125634BACKGROUND
  • Andrews 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: 10789025BACKGROUND
  • Arinami 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

Tobacco Use DisorderSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Elliot Stein, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

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

Locations