Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Nicotine; Varenicline

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)