Tobacco Cessation in Postmenopausal Women - Part I & Part II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy?
研究概览
简要总结
This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.
Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.
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
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •40-79 years old
- •Clinical Menopause
- •> 15 cigarettes per day for at least one year
- •Experienced nicotine withdrawal based on DSM IV
排除标准
- •Currently obtaining nicotine from other sources
- •Abnormal vaginal bleeding
- •unstable health
- •history of stroke or embolism
- •history of abnormal thyroid function
- •significant skin disorders
- •active psychiatric disease
结局指标
主要结局
During short term smoking abstinence, do the beneficial effects of nicotine replacement therapy on acute symptomatology differ in women who use and do not use hormone replacement therapy?
时间窗: Outcome was measured after 1 baseline week and a 2 week quit
次要结局
未报告次要终点