| Eligibility |
Inclusion Criteria:
- Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within
the 2 months preceding the screening visit and expired carbon monoxide (CO) greater
than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)
- Interested in treatment that might change smoking behavior
- Able to follow verbal and written instructions in English and complete all aspects of
the study
- Provide informed consent and agree to all assessments and study procedures
- Have an address and telephone number where they may be reached
- Be the only participant in their household
Exclusion Criteria:
- Within the month immediately preceding the screening visit, use of any form of tobacco
products other than cigarettes, little cigars or cigarillos on 3 or more days within a
week if the individual refuses to refrain from such tobacco use during the course of
the study
- Current enrollment or plans to enroll in another smoking cessation program in the next
6 months
- Plan to use other nicotine substitutes (i.e., over-the-counter [OTC] or prescription
medication for smoking cessation) or smoking cessation treatments in the next 6 months
- Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic
blood pressure [DBP] greater than 110)
- Reports diagnosis of seizure disorder or a history of neurological illness or closed
head injury that in the opinion of the principal investigator (PI) or designated
expert(s) feels that it would affect the results of the electroencephalogram (EEG)
- Current use of certain medications:
- Smoking cessation meds (last 7 days), i.e., Wellbutrin, bupropion, Zyban, NRT,
Chantix
- Certain medications to treat depression (last 14 days), i.e. monoamine oxidase
inhibitors (MAOIs) and Elavil (amitriptyline), or
- Other medications listed on the exclusionary medications list
- Meet criteria for the following psychiatric and/or substance use disorders as assessed
by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or
hypomanic episode only), I (alcohol abuse - alcohol addendum-past 6 months only;
current alcohol dependence), J (substance abuse - substance abuse addendum - past 6
months only; current substance dependence), K (psychotic disorder or mood disorder
with psychotic features); individuals who meet criteria for non-exclusionary
psychiatric disorders that are considered clinically unstable and/or unsuitable to
participate as determined by the principal investigator
- Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as
assessed by module B of the MINI
- Psychiatric hospitalization within 1 year of screening date
- A positive urine pregnancy test during the screening period; women who are two years
post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy
will not be subject to a urine pregnancy test
- Pregnant, breast-feeding or of childbearing potential and is not protected by a
medically acceptable, effective method of birth control while enrolled in the study;
medically acceptable contraceptives include: (1) approved hormonal contraceptives
(such as birth control pills, patches, implants or injections), (2) barrier methods
(such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device
(IUD); contraceptive measures sold for emergency use after unprotected sex are not
acceptable methods for routine use
- History of hypersensitivity or allergic reaction to NRT, or any component of its
formulation
- Any medical or psychiatric condition, illness, disorder, or concomitant medication
that could compromise participant safety or treatment, as determined by the principal
investigator
- Subject considered by the investigator as unsuitable candidate for receipt of NRT, or
unstable to be followed up throughout the entire duration of the study
- Must not have visual problems that in the investigators opinion would interfere in the
completion of the study assessments
- Unwilling to change hairstyle or remove a wig as necessary for the appointment to
accommodate the net that is required to be worn on the scalp during the study
procedure
- Positive toxicology screen for any of the following drugs: cocaine, opiates,
methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or
phencyclidine (PCP)
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates,
amphetamines or methadone will not be excluded
- Participants failing the toxicology screen will be allowed to re-screen once; if
they test positive again, they will not be allowed to return for 90 days
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