Nicotine Dependence Clinical Trial
Official title:
Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
Verified date | August 28, 2013 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
- Treatment for nicotine addiction is characterized by high rates of relapse. New
treatment therapies for nicotine addiction are exploring the use of brain scanning
equipment to control and decrease nicotine and cigarette cravings.
- Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain.
These pulses can change activity in parts of the brain. Researchers are interested in
determining whether TMS delivered in single pulses can decrease activity in the parts of
the brain that respond to nicotine craving.
Objectives:
- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in
cigarette smokers.
Eligibility:
- Individuals 18 years of age and older who are physically healthy and have smoked 10 or
more cigarettes per day for at least 1 year.
- A small group of healthy nonsmoking control subjects 18 years of age and older will also
participate in the study.
Design:
- The study will involve seven study visits and two follow-up visits. The control
participants will have only two visits: one with a magnetic resonance imaging (MRI) scan
and one with TMS to evaluate brain function and response.
- Participants will have an initial assessment about tobacco use habits and craving
patterns, and will provide blood and urine samples before beginning the study.
- Participants will have two initial MRI brain scans. The first scan will look at the
structure of the brain at rest. During the other scan, participants will look at images
related to and not related to cigarette smoking.
- The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be
held daily for 5 consecutive days. Magnetic pulses will be triggered by
cigarette-related picture cues and delivered at varying intervals before the participant
sees a cigarette-related picture. During these testing visits, researchers will ask
questions related to tobacco use and craving, and collect urine and breath samples for
further study.
- Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions,
to evaluate memory and mood, and will have one final MRI brain scan at the end of the
study.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 28, 2013 |
Est. primary completion date | August 28, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
-INCLUSION CRITERIA: i) Eighteen years of age or older ii) Current nicotine dependence (by DSM-IV criteria or Fagerstrom Test for Nicotine Dependence score greater than or equal to 3) and averaging smoking 10 or more cigarettes per day for at least one year. iii) Reading level of at least 6th grade, based on the Wide Range Achievement Test (WRAT) iv) Ability to give valid informed consent v) Right-handed vi) 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 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. vii) Self-report experiencing nicotine craving when exposed to nicotine-associated cues EXCLUSION CRITERIA: i) 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. ii) 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. iii) Metal shrapnel or bullet in the head or body including metal shavings. iv) Current use of any investigational drug or of any medications with anti or pro-convulsive action v) Increased intracranial pressure (lowers seizure threshold) vi) Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania vii) History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care. viii) Pregnant or nursing women or women with reproductive potential who are sexually active and not using an acceptable form of contraception. ix) Any history of seizure x) Current dependence (DSM-IV criteria) on substances other than nicotine. |
Country | Name | City | State |
---|---|---|---|
United States | National Institute on Drug Abuse | Baltimore | Maryland |
United States | Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue | Catonsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) | University of Maryland |
United States,
Allen EA, Pasley BN, Duong T, Freeman RD. Transcranial magnetic stimulation elicits coupled neural and hemodynamic consequences. Science. 2007 Sep 28;317(5846):1918-21. — View Citation
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. — View Citation
Bestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nicotine craving by Tobacco Craving Questionnaire and visual-analogue scales. | 2 weeks | ||
Secondary | Cigarette use by self-report, salivary cotinine level, and expired breath CO levels. | 2 weeks |
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