Smoking Cessation in Women With Gynecological Conditions
Smoking Cessation in Women With Gynecological Conditions
This feasibility study will compare two smoking cessation methods, traditional nicotine
 replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in
 patients 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.