Smoking Cessation in Women With Gynecological Conditions (NCT01989923) | Clinical Trial Compass
CompletedNot Applicable
Smoking Cessation in Women With Gynecological Conditions
United States31 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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.