Conditions: Nicotine Dependence
Keywords: Menstrual Cycle effects Cue Reactivity Smoking Cessation Impulsivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: yes

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.

Arms:
arm 1: Participant randomized to receive active varenicline and placebo transdermal nicotine patch. arm 2: Participant randomized to receive active transdermal nicotine patch and placebo varenicline.

Interventions: intervention 1: varenicline intervention 2: transdermal nicotine patch
Intervention descriptions: intervention 1: 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. intervention 2: Weeks 0-3: 21mg patch

Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Protocol document: