Clinical trial NCT01989923: Smoking Cessation in Women With Gynecological Conditions
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Keywords: Smoking cessation
Traditional nicotine replacement therapy
Electronic nicotine delivery devices
electronic cigarettes
cervical dysplasia
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: We plan a 3-month study with 6 week follow-up periods.
Secondary outcomes:
measure: Feasibility of Study
timeFrame: 3 months with 6 week follow-up windows
Other outcomes:
measure: Product Adherence Diary
timeFrame: Women fill out diary every day for 12 weeks
measure: Composite set of semi-structured interviews
timeFrame: done at the end of the study (at 12-weeks)
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Sciences Center, College of Public Health
name: Laura A Beebe, PhD
role: PRINCIPAL_INVESTIGATOR
References: