Smoking, Antidepressants, and Response to Mental Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure Response to Stress
研究概览
简要总结
Smokers report that they often smoke cigarettes during stressful times. The combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. This combination may result in greater cardiovascular harm than either smoking or stress alone. The purpose of this study is to determine the effects of paroxetine on the response to stress after smoking.
详细描述
Smokers report that they often smoke cigarettes during stressful times. Smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. The combination of smoking and stress results in greater increases in these physiological responses compared to smoking or stress alone. Such increases are thought to be harmful to cardiovascular health. Additionally, smokers with exaggerated responses to stress may be more likely to relapse following a smoking cessation attempt. The purpose of this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor (SSRI), on the cardiovascular response to stress after smoking.
Participants in this double-blind, placebo-controlled study will receive 1 month of paroxetine and 1 month of placebo with the order of which is taken during the first month randomly assigned. Paroxetine will be administered at a daily dose of 10 mg for the first week and increased to a daily dose of 20 mg for the remainder of the study. After one month of medication, participants will abstain from smoking for one night and then undergo mental stress testing the following day. Immediately prior to the mental stress testing, participants will smoke a cigarette. Mental stressors will include speaking and math tasks. Physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine concentrations) and subjective measures of stress will be evaluated. Following the second month of medication, participants will again undergo the procedure for mental stress testing and evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokes an average of at least 10 cigarettes per day during the year prior to enrollment
排除标准
- •Interested in quitting smoking within the 3 months following enrollment
- •Current unstable medical condition
- •Substance abuse within the year prior to enrollment
- •Current use of any medications (e.g., psychoactive medications, antihypertensives) that, in the opinion of the investigators, might interfere with study measures or that would be expected to interact with paroxetine (e.g., CYP2D6 substrates)
- •Smoking cessation therapy within the 3 months prior to enrollment
- •Regular use of any form of tobacco other than cigarettes
- •Significant psychiatric disorders as assessed by the PRIME-MD and verified by a clinician
- •History of hypersensitivity to any selective serotonin reuptake inhibitor
- •Pregnancy or breastfeeding
研究组 & 干预措施
1
Active medication for 4 weeks followed by placebo for 4 weeks
干预措施: Paroxetine (Drug)
1
Active medication for 4 weeks followed by placebo for 4 weeks
干预措施: Placebo (Drug)
2
Placebo for 4 weeks followed by active for 4 weeks
干预措施: Paroxetine (Drug)
2
Placebo for 4 weeks followed by active for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic Blood Pressure Response to Stress
时间窗: After 4 weeks of paroxetine / placebo
Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette
次要结局
未报告次要终点
