NCT01989923

Smoking Cessation in Women With Gynecological Conditions

Immediate Smoking Cessation for Patients at Risk for Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer - A Feasibility Study Comparing Nicotine Replacement Therapy With the Electronic Nicotine Delivery System.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Dysplasia

Interventions

Type	Name	Description
OTHER	Nicotine Replacement Therapy	Patients will use one patch per day for 6 weeks for a total of 42 patches - they will receive 7 the first visit and then the additional 35 at the second visit. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation.
DEVICE	Electronic Cigarettes	The number of cartridges for the electronic cigarettes is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day. We plan to decrease the strength of the cartridges by one half after three weeks of intervention. We will give each women supplies and instructions accordingly. This will allow for a lower strength of nicotine as each woman continues with smoking cessation

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-04-13
• Completion: 2017-04-13
• First posted: 2013-11-21
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States