Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- End-of-treatment Abstinence
研究概览
简要总结
This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Varenicline
Participant randomized to receive active varenicline and placebo transdermal nicotine patch.
干预措施: varenicline (Drug)
Transdermal Nicotine Patch
Participant randomized to receive active transdermal nicotine patch and placebo varenicline.
干预措施: transdermal nicotine patch (Device)
结局指标
主要结局
End-of-treatment Abstinence
时间窗: 2 weeks
Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment
次要结局
未报告次要终点
研究者
Kevin Gray, MD
Principal Investigator
Medical University of South Carolina
