Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Phase 2

Completed

Conditions: Nicotine Dependence

Interventions: Device: transdermal nicotine patch
Drug: varenicline

Registration Number: NCT00664755

Lead Sponsor: Medical University of South Carolina

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

Detailed Description: This component builds directly upon the results of the previously funded project in systematically investigating the impact of short-term ovarian hormone fluctuation on females as they try to quit smoking with the aid of either transdermal nicotine patch (TNP) or varenicline. Each participant will receive a standardized impulsivity evaluation and a laboratory-based cue reactivity assessment before the initiation of smoking cessation. Progesterone and estrogen levels will be measured at each of nine visits, thereby providing an index of reproductive hormone variation over the course of each participant's quit attempt. This novel approach of integrating a human laboratory cue reactivity paradigm directly with a treatment outcome study will permit us to assess whether or not smoking cue reactivity has predictive utility with respect to cessation outcome. Subjects will be randomized to receive one of two active pharmacotherapeutic interventions for smoking cessation: TNP vs. varenicline in a randomized, single-blind, double dummy design. While TNP has demonstrated modest efficacy in improving smoking cessation outcomes, there is some evidence that its efficacy may be more robust in men as compared to women. This project will provide important information about a) the impact of ovarian hormone levels on smoking cessation outcomes, b) the relationship between smoking cue reactivity and smoking cessation, and c) comparison between a new pharmacotherapeutic agent and TNP in women.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 140

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal Nicotine Patch	transdermal nicotine patch	Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
Varenicline	varenicline	Participant randomized to receive active varenicline and placebo transdermal nicotine patch.

Primary Outcome Measures