ABOUT THIS STUDY
1. Age: 18-75 years old
2. 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 = 5, then NicAlert Strip >2).
3. Interested in treatment that might change smoking behavior
4. Able to follow verbal and written instructions in English and complete all aspects of the study
5. Provide informed consent and agree to all assessments and study procedures
6. Have an address and telephone number where they may be reached
7. Be the only participant in their household
1. 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
2. Current enrollment or plans to enroll in another smoking cessation program in the next
3. Plan to use other nicotine substitutes ( i.e., OTC or prescription medication for
smoking cessation) or smoking cessation treatments in the next 12 months
4. Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic
blood pressure; DBP greater than 110)
5. History of severe kidney disease (e.g chronic or acute kidney failure) with creatinine
clearance below 30 and/or severe liver disease with liver tests over 4 times the upper
6. Laboratory evaluations (kidney and liver) outside normal limits and of potential
clinical significance in the opinion of the investigator
7. Serious or unstable disease within the past 3 months
8. History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke,
angina, heart attack) may result in ineligibility. These conditions will be evaluated
on a case by case basis by the Study Physician.
9. Current use of certain medications: (1) Smoking cessation meds (last 7 days), i.e.,
Wellbutrin, Bupropion, Zyban, NRT, Chantix, (2) Certain medications to treat
depression (last 14 days), i.e. MAOIs and Elavil (Amitriptyline), (3) A case by case
determination will be made by study physician for medication on precautionary list,
i.e. nitroglycerin, or (4) Daily use of opioids for 30 days or more on phone screen or
at screening is exclusionary however PRN use is allowed (i.e., 3:7 days per week or
less or if more frequent, use less than a month's duration.
10. 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 (current/lifetime psychotic disorder or
current/lifetime 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 and/or
11. Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as
assessed by Module B of the MINI.
12. Psychiatric hospitalization within 1 year of screening date.
13. 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.
14. 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.
15. History of hypersensitivity or allergic reaction to Varenicline, NRT, or any component
of these formulations.
16. Any medical or psychiatric condition, illness, disorder, or concomitant medication
that could compromise participant safety or treatment, as determined by the Principal
Investigator and/or Study Physician.
17. Subject considered by the investigator as unsuitable candidate for receipt of an
investigational drug, or unstable to be followed up throughout the entire duration of
18. Positive toxicology screen for any of the following drugs: cocaine, opiates,
methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, PCP, or THC.
A. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates,
amphetamines or methadone will not be excluded. B. Participants failing the toxicology
screen will be allowed to re-screen once. If they test positive again, they will not
be allowed to return.
19. Must not have visual problems that in the investigators opinion would interfere in the
completion of the study assessments
20. 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
21. Reports diagnosis of seizure disorder or a history of neurological illness or closed
head injury that in the opinion of the PI feels that it would affect the results of
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