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|NCT02697227 : Behavioral Activation Therapy for Smoking Cessation|
|Ages||Min: 18 Years Max: 75 Years|
1. Age: 18-75 years old
2. Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the
screening visit and expired carbon monoxide (CO) less than or equal to 6ppm.
3. Interested in treatment that might change smoking behavior
4. Able to follow verbal and written instructions in English and complete all aspects of
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 or little cigars 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 6 months
3. 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
4. Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic
blood pressure; DBP greater than 110)
5. Serious or unstable disease within the past 3 months
6. 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. monoamine oxidase inhibitors (MAOIs) and Elavil
(Amitriptyline), or (3) Daily use of opioids for 30 days or more on phone screen or
at screening is exclusionary however PRN (when necessary) use is allowed (i.e., 3:7
days per week or less or if more frequent, use less than a month's duration.)
7. 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 psychotic
disorder or current 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
8. Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as
assessed by Module B of the MINI.
9. Psychiatric hospitalization within 1 year of screening date.
10. 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.
11. 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.
12. History of hypersensitivity or allergic reaction to NRT, or any component of its
formulation (including allergy to latex).
13. Any medical or psychiatric condition, illness, disorder, or concomitant medication
that could compromise participant safety or treatment, as determined by the Principal
14. 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.
15. Must not have visual or auditory problems that in the investigators opinion would
interfere in the completion of the study assessments
16. Unwilling to change hair style 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
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