Smoking Cessation in Women With Gynecological Conditions

Brief Title

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.

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.
    

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Feasibility of Study

Condition

Cervical Dysplasia

Intervention

Nicotine Replacement Therapy

Study Arms / Comparison Groups

 Nicotine replacement therapy

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

31

Start Date

June 2013

Completion Date

April 13, 2017

Primary Completion Date

April 13, 2017

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.
      

Gender

Female

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Laura A Beebe, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01989923

Organization ID

2506

Responsible Party

Sponsor

Study Sponsor

University of Oklahoma

Study Sponsor

Laura A Beebe, PhD, Principal Investigator, University of Oklahoma Health Sciences Center, College of Public Health

Verification Date

April 2017