Nicotine Dependence Clinical Trial
Official title:
Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI
Verified date | November 26, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 249 |
Est. completion date | November 26, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- INCLUSION CRITERIA: 1. Subjects must be between the ages of 18-50. 2. Subject must be in good health based on history and physical exams. 3. Subjects must be right-handed. 4. 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. 5. Subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence on either substance. EXCLUSION CRITERIA: 1. Are pregnant or breast feeding. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session. 2. 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. 3. 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. 4. Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced psychiatric disorders. 5. Have neurological illnesses to including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor. 6. Have significant alcohol or other drug use, other than nicotine dependence. 7. Have gros structural abnormalities onT1 weighted images. 8. 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. 9. Are engaged in or actively seeking smoking cessation treatment. |
Country | Name | City | State |
---|---|---|---|
United States | National Institute on Drug Abuse, Biomedical Research Center (BRC) | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Aceto MD, Martin BR. Central actions of nicotine. Med Res Rev. 1982 Jan-Mar;2(1):43-62. Review. — View Citation
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 ( Pt 1):11-26. — View Citation
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. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05176418 -
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
|
Early Phase 1 | |
Completed |
NCT04084210 -
Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
|
Phase 2 | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Withdrawn |
NCT03707600 -
State and Trait Mediated Response to TMS in Substance Use Disorder
|
N/A | |
Recruiting |
NCT03999099 -
Targeting Orexin to Treat Nicotine Dependence
|
Phase 1 | |
Completed |
NCT03847155 -
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
|
N/A | |
Completed |
NCT02840435 -
Study on Sit to Quit Phone Intervention
|
N/A | |
Completed |
NCT02139930 -
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
|
N/A | |
Completed |
NCT01982110 -
A Mindfulness Based Application for Smoking Cessation
|
N/A | |
Completed |
NCT01926626 -
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
|
Phase 2 | |
Completed |
NCT01685996 -
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
|
Phase 1/Phase 2 | |
Completed |
NCT01569490 -
Striving to Quit: First Breath
|
N/A | |
Completed |
NCT01632189 -
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
|
N/A | |
Withdrawn |
NCT01569477 -
Striving to Quit-Wisconsin Tobacco Quit Line
|
N/A | |
Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT00996034 -
Nicotine Vaccination and Nicotinic Receptor Occupancy
|
Phase 2 | |
Completed |
NCT01061528 -
Coping Skills Treatment for Smoking Cessation
|
N/A | |
Withdrawn |
NCT01589081 -
Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
|
N/A | |
Suspended |
NCT01636336 -
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
|
N/A | |
Completed |
NCT01943994 -
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
|
N/A |