Smoking Cessation in Women With Gynecological Conditions

This study will allow women with serious gynecological conditions to sample both traditional
nicotine replacement therapy (NRT) and Electronic Nicotine Delivery Systems (electronic
cigarettes, ENDS). Whether the woman samples NRT or ENDS first will be randomized. Women
will choose the product they wish to try for a 6-week intervention period for smoking
cessation. Women choosing NRT will receive a 6-week intervention of a daily nicotine patch
plus either nicotine gum or lozenges to use (as needed) throughout the day. The ENDS group
will receive an electronic cigarette device with refills to last the 6-week duration of the
study. Both groups will receive identical tobacco cessation counseling. As part of the
study, each subject will complete a survey conducted at baseline, 6-weeks into the study
during intervention, and upon completion of a 6 week follow-up period in which participants
receive no intervention. At the 12-week measurement period we will add a qualitative
interview that will allow us to ask the women whether the methods were acceptable, caused
any problems, and if so, what the problems entailed.

Inclusion Criteria:

- Female

- Smokers (defined as those who have smoked at least daily for the last year and who
have smoked greater than or equal to 10 or more combustible cigarettes per day during
the last year.

- Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital
Tract Dysplasia and Cancer

- Ages 18-65 years

Exclusion Criteria:

- Patients unwilling to commit to a 6-week intervention that may include either NRT or
ENDS.

- Patients with previous diagnoses of or treatment for cancer - with the exception of
non-melanoma skin cancer.

- Presence of any known stroke, heart disease, heart attack, or irregular heart beat.

- Pregnancy and lactation.

- Plan to continue to use other nicotine in addition to the products supplied by the
study. These would include: chewing tobacco, snuff, an additional nicotine patch or
other nicotine containing products.

- High blood pressure, not well controlled with medication.

- Patients using a non-nicotine "smoking cessation medication."

- Patients taking a prescription medicine for depression or asthma.