Studying Nicotine Addiction With Transcranial Magnetic Stimulation
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2019 |
| Start Date: | September 10, 2012 |
| End Date: | October 3, 2017 |
Understanding the Neurocircuitry of Nicotine Addiction Using Repetitive Transcranial Magnetic Stimulation (rTMS)
Background:
- Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand
the areas of the brain that are important in nicotine addiction. They will use a type of
brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part
of the brain that may be involved in nicotine addiction. They will see how these areas affect
brain function, thinking, and decision making. For this study, rTMS will first be tested on
nonsmokers, then smokers will be recruited at a later time.
Objectives:
- To study areas of the brain involved in nicotine addiction.
Eligibility:
- Individuals at least 18 years of age who do not smoke.
Design:
- Participants will be screened with a physical exam and medical history. They will also
provide a urine sample.
- There will be four study sessions. The first session will involve a magnetic resonance
imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.
- The first MRI scan will take a baseline picture of the brain. Participants will also
practice the tasks for the other three sessions in a mock scanner.
- At the next three visits, participants will have rTMS and MRI scans. Two visits will
involve rTMS; the other visit will involve mock rTMS with no actual magnetic
stimulation. During the MRI scans, participants will perform tasks that involve decision
making.
- Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand
the areas of the brain that are important in nicotine addiction. They will use a type of
brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part
of the brain that may be involved in nicotine addiction. They will see how these areas affect
brain function, thinking, and decision making. For this study, rTMS will first be tested on
nonsmokers, then smokers will be recruited at a later time.
Objectives:
- To study areas of the brain involved in nicotine addiction.
Eligibility:
- Individuals at least 18 years of age who do not smoke.
Design:
- Participants will be screened with a physical exam and medical history. They will also
provide a urine sample.
- There will be four study sessions. The first session will involve a magnetic resonance
imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.
- The first MRI scan will take a baseline picture of the brain. Participants will also
practice the tasks for the other three sessions in a mock scanner.
- At the next three visits, participants will have rTMS and MRI scans. Two visits will
involve rTMS; the other visit will involve mock rTMS with no actual magnetic
stimulation. During the MRI scans, participants will perform tasks that involve decision
making.
Objective: To investigate the neurocircuitry cognitive and affective processing relevant to
nicotine addiction using repetitive Transcranial Magnetic Stimulation (rTMS). Specifically,
we will examine insula neurocircuitry using a unilateral H-coil to deliver rTMS to the Right
dorsolateral prefrontal cortex (R DLPFC) and insula. We will examine the effect of various
stimulation parameters on behavior as well as on task based activation and resting state
functional connectivity (rsFC) during fMRI scanning.
Study population: Up to 60 healthy adults who are non-smokers will be enrolled to achieve 28
completers.
Design: Within subject design with each subject completing 4 sessions: rTMS at two different
stimulation frequencies and 2 sham sessions.
Outcome measures: Behavior on a decision making task and task based and resting state blood
oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction
during fMRI scanning.
nicotine addiction using repetitive Transcranial Magnetic Stimulation (rTMS). Specifically,
we will examine insula neurocircuitry using a unilateral H-coil to deliver rTMS to the Right
dorsolateral prefrontal cortex (R DLPFC) and insula. We will examine the effect of various
stimulation parameters on behavior as well as on task based activation and resting state
functional connectivity (rsFC) during fMRI scanning.
Study population: Up to 60 healthy adults who are non-smokers will be enrolled to achieve 28
completers.
Design: Within subject design with each subject completing 4 sessions: rTMS at two different
stimulation frequencies and 2 sham sessions.
Outcome measures: Behavior on a decision making task and task based and resting state blood
oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction
during fMRI scanning.
- INCLUSION CRITERIA:
1. Males and females 18 - 55 years of age
2. Able to give valid informed consent
3. Right-handed
4. If the subject is female, of childbearing potential, and sexually active, she
agrees to use a medically acceptable contraception, and not become pregnant for
the duration of the study. A woman is considered of childbearing potential unless
post-menopausal or surgically sterilized. Female patients of childbearing
potential who are or who anticipate the possibility of becoming sexually active
with a male partner must use either: (1) contraceptive pill or intrauterine
device (IUD) or depot hormonal preparation (ring, injection implant); and/or (2)
a barrier method of contraception such as diaphragm, sponge with spermicide, or
condom. Women who are not sexually active do not have to agree to use one of the
acceptable contraception methods. Contraceptive measures will be reviewed with
female subjects at each visit prior to the TMS session.
EXCLUSION CRITERIA:
1. Personal or first-degree family history of any clinically defined neurological
disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple
sclerosis, previous neurosurgery, or personal history of head trauma that resulted in
loss of consciousness.
2. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted
medication pumps, intracardiac lines, or acute, unstable cardiac disease, with
intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or
electrodes) or any other metal object within or near the head that cannot be safely
removed.
3. Current use, or use in the past 4 weeks of any investigational drug or of any
medications with psychotropic, anti or pro-convulsive action
4. Increased intracranial pressure (lowers seizure threshold)
5. Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania,
or hypomania or current substance abuse or dependence or past dependence by DSM IV
criteria, or urine toxicology positive for any illicit substance.
6. History of myocardial infarction, angina, congestive heart failure, cardiomyopathy,
stroke or transient ischemic attack, or any heart condition currently under medical
care.
7. Pregnant or nursing women or women with reproductive potential who are sexually active
and not using an acceptable form of contraception.
8. Any history of seizure
We found this trial at
1
site
6001 Executive Boulevard, Room 5213
Baltimore, Maryland 20892
Baltimore, Maryland 20892
301-443-1124
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