Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01031693
Eligibility Criteria:
-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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01031693
Study Brief:
Protocol Section:
NCT01031693