Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: varenicline; transdermal nicotine patch
Intervention description: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID
Varenicline is taken for a duration of 4 weeks in this study.; Weeks 0-3: 21mg patch
Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menstrual Cycle effects; Cue Reactivity; Smoking Cessation; Impulsivity

Summary:

      This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP)
      versus varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-45. Individuals over the age of 45 will not be included as we are examining the
             effects of menstrual cycle and ovarian hormones.

          -  Daily smokers who smoke at least 10 cigarettes per day for at least past 6 months.

          -  Post menarche and pre menopausal

          -  Regular menstrual cycle between 25 and 35 days

          -  At least three months post delivery and breast feeding

          -  Desire to quit smoking and willingness to participate in a research study.

          -  Women with a history of depression (but not current MDE) and current PMDD will be
             included. Excluding women with these diagnoses would have a major impact on
             feasibility, but because both disorders might impact treatment outcome, individuals
             will be stratified across randomization groups.

        Exclusion Criteria:

          -  Any unstable major axis I psychiatric disorder in the past month

          -  Current substance use disorders other than nicotine and caffeine use, in the past 30
             days.

          -  Any medication that may interfere with psychophysiological monitoring

          -  Unstable medical or serious medical condition in the past 6 months

          -  Hypersensitivity to varenicline or TNP

          -  Use of other tobacco products

          -  Use of other medications with smoking cessation efficacy within 30 days prior to
             enrollment

          -  BMI less than 15 since this could alter hormone levels that affect menstrual phase

          -  Pregnancy

          -  Breast feeding

          -  Status post hysterectomy

          -  Birth control or HRT medication that would effect the menstrual cycle. Currently
             available oral contraceptives contain either a combination of a synthetic estrogen and
             synthetic progestin, or a progestin alone. Estrogen and/or progestin inhibit ovulation
             and alter cervical mucus and the endometrium by suppressing the production of
             follicle-stimulating hormone and the luteinizing hormone surge (Bucci & Carson, 1997)