Smoking Cessation in Women With Gynecological Conditions
This trial is active, not recruiting.
|Treatments||nicotine replacement therapy, electronic cigarettes|
|Sponsor||University of Oklahoma|
|Start date||June 2013|
|End date||April 2016|
|Trial size||31 participants|
|Trial identifier||NCT01989923, 2506|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
time frame: We plan a 3-month study with 6 week follow-up periods.
Feasibility of Study
time frame: 3 months with 6 week follow-up windows
Female participants from 18 years up to 65 years old.
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.
|Official title||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.|
|Principal investigator||Laura A Beebe, PhD|
|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.|
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