Overview

This trial is active, not recruiting.

Condition cervical dysplasia
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
nicotine replacement therapy Nicoderm CQ patches (21 or 14 mg patches)
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.
(Active Comparator)
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.
electronic cigarettes Blu Cig Electronic Nicotine Delivery System
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

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
time frame: We plan a 3-month study with 6 week follow-up periods.

Secondary Outcomes

Measure
Feasibility of Study
time frame: 3 months with 6 week follow-up windows

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Oklahoma.