Smoking Cessation in Women With Gynecological Conditions

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cervical Dysplasia

Intervention / Treatment
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* Other: Nicotine Replacement Therapy
* Device: Electronic Cigarettes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine replacement therapy<br>Women in this arm of the study will receive 24-hour Nicotine Patches - either 21 mg patches (for 1 pack per day smokers), or 14 mg patches (for 1/2 pack per day smokers) smokers). Patients will use one patch per day for 6 weeks for a total of 42 patches. 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. Women will also receive nicotine gum or lozenges (subject choice)- these will be 2 mg pieces of nicotine gum or lozenge (approximately 210 pieces). This will account for using 8-10 per day at the beginning of the study and tapering to 2-3 pieces per day by the end of the study. | Other: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Nicorette lozenges (2 mg);|
| Active Comparator: Electronic Cigarettes<br>Women in this arm of the study will receive one Blu Cig Electronic Nicotine Delivery Device (E-cigarette) along with 2 electronic cigarette batteries, 1 wall charger and 1 USB charger, cartridges/refills in menthol or regular (patient choice). The number of cartridges 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. | Device: Electronic Cigarettes<br>* 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<br>* Other names: Blu Cig Electronic Nicotine Delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite set of questions about the feasibility of successfully using NRT and ENDS over time (assessing change in smoking habits) in Women with Serious Gynecological Conditions | To determine the acceptability of traditional nicotine replacement therapy (nicotine patch plus nicotine gum or lozenges) and the ENDS (electronic nicotine delivery system or electronic cigarette as smoking cessation tools in a group of women with cervical dysplasia from the Stephenson Cancer Center Dysplasia Clinics. Measurements to assess success: Reduction of number of cigarettes smoked per day. Point prevalence abstinence at 7 and 30 days Smoking cessation rates Qualitative interviews to assess positives and negatives in these two smoking cessation methods. | We plan a 3-month study with 6 week follow-up periods. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Study | To determine if we can accure 30 smoking women with cervical dysplasia from the Stephenson Cancer Center for smoking cessation intervention in a 6-month window. | 3 months with 6 week follow-up windows | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Traditional nicotine replacement therapy, Electronic nicotine delivery devices, electronic cigarettes, cervical dysplasia