Smoking Cessation in Women With Gynecological Conditions

NCT ID: NCT01989923

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-04-13

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.

Conditions

Cervical Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nicotine replacement therapy

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.

Group Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy

Intervention Type: OTHER

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.

Electronic Cigarettes

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.

Group Type: ACTIVE_COMPARATOR

Electronic Cigarettes

Intervention Type: DEVICE

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

Interventions

Nicotine Replacement Therapy

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.

Intervention Type: OTHER

Electronic Cigarettes

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

Intervention Type: DEVICE

Other Intervention Names

Nicoderm CQ patches (21 or 14 mg patches); Nicorette gum (2 mg); Nicorette lozenges (2 mg); Blu Cig Electronic Nicotine Delivery System

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A Beebe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Sciences Center, College of Public Health

Locations

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

2506

Identifier Type: -

Identifier Source: org_study_id