Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Nicotine Effects Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male smokers, not treatment seeking, aged 18 to 55 years;
- •history of smoking daily for the past 12 months, at least 5 cigarettes daily;
- •CO level > 10ppm;
- •for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
排除标准
- •history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
- •regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- •recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
- •use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
- •known allergy to atomoxetine
研究组 & 干预措施
Placebo
placebo
干预措施: Placebo (Drug)
Atomoxetine
atomoxetine (40 mg/day)
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Nicotine Effects Questionnaire
时间窗: Day 17
Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.
次要结局
- Center for Epidemiologic Studies Depression (CES-D) scale(Day 17)
- Positive and Negative Affect Schedule (PANAS )(Day 17)
- Symptom Checklist Form (SCF)(Day 17)
- Nicotine Withdrawal Symptom Checklist (NWSC)(Day 17)
- The Profile of Mood States (POMS)(Day 17)