NCT01989923.

Study name	Smoking cessation in women with gynaecological conditions
Methods	Randomized controlled trial, open‐label feasibility study Setting: hospital clinic, USA Recruitment: in clinic
Participants	30 women who smoke with cervical dysplasia Inclusion criteria: Women who smoke at least 10 cpd over past year Diagnosis of cervical dysplasia, cervical cancer, and lower genital tract dysplasia and cancer Aged 18 ‐ 65 Exclusion criteria: Previous diagnoses or treatment for cancer (except for non‐melanoma skin cancer) Stroke, heart disease, heart attack, or irregular heart beat Pregnancy and lactation Plan to continue to use other nicotine as well as study products Uncontrolled hypertension Using other stop‐smoking medication Taking prescription medicine for depression or asthma
Interventions	NRT patch (21 mg for first 3 weeks, 14 mg for 2nd 3 weeks) plus nicotine gum (2 mg) or lozenges (2 mg) for 6 weeks EC device ('Blu' Cig) with refills to last 6 weeks, number provided based on packs smoked a day x 1.5. Strength of EC reduced at 3 weeks Both groups receive identical cessation counselling
Outcomes	At 6 and 12 weeks via survey: Cpd PPA at 7 and 30 days Smoking cessation Participants' attitudes and beliefs towards treatments Adherence
Starting date	June 2013
Contact information	Laura A Beebe, laura-beebe@ouhsc.edu
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