An interventional study of Nicotine Replacement Therapy and Electronic Cigarettes in Cervical Dysplasia, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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.
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 31 is below the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
Also known as: Nicoderm CQ patches (21 or 14 mg patches), Nicorette gum (2 mg), Nicorette lozenges (2 mg)
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
Also known as: Blu Cig Electronic Nicotine Delivery System
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: 1. Reduction of number of cigarettes smoked per day. 2. Point prevalence abstinence at 7 and 30 days 3. Smoking cessation rates 4. Qualitative interviews to assess positives and negatives in these two smoking cessation methods.
Time frame: We plan a 3-month study with 6 week follow-up periods.
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.
Time frame: 3 months with 6 week follow-up windows
Product Adherence Diary
The diary will be used for the 6 week intervention portion of the study. This diary is designed to assist individuals in monitoring their smoking and product use during the study. We will encourage each subject to write down every regular cigarette that she smokes as well as every use of the product to which she has been randomized.
Time frame: Women fill out diary every day for 12 weeks
Composite set of semi-structured interviews
We will use semi-structured interviews at the 12 week follow-up to help us understand: * If the woman currently feels she has a healthy or unhealthy lifestyle, and what factors contribute to this answer. * What smoking cessation methods the women have tried in the past, if the methods were acceptable, if they worked, and why or why not. * Barriers that might make it difficult for women with this diagnosis to quit smoking using the device they tried in the study. * Assists that might make it easier for women with this diagnosis to quit smoking using the device they tried in the study. * How the women feel about continuing to use the device that they tried in the trial. * Risks the women feel they are taking if they continue to use NRT, ENDS, or decide to return to smoking. * What about smoking makes it worth or not worth the risk to these women personally.
Time frame: done at the end of the study (at 12-weeks)
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Oklahoma