Treatment of Nicotine Dependence and Acute Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Can Depression and Smoking Cessation be Treated Simultaneously
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.
详细描述
The purpose of this study is to assess the safety and feasibility of concurrent treatment of nicotine dependence (cigarette smoking) and acute depression. Participants who meet DSM-IV criteria for both nicotine dependence and acute major depression will be given pharmacological treatment for both disorders at the same time, along with a brief behavioral intervention for smoking cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 at the beginning of the study
- •Smoking at least 10 cigarettes a day (1/2 pack)
- •Meets DSM-IV criteria for major depressive episode
排除标准
- •Currently pregnant
- •Currently breastfeeding
- •Currently diagnosed with a seizure disorder, liver disease, kidney disease, congestive heart failure or diabetes mellitis
- •History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- •Family history of seizures
- •Currently using intravenous drugs
- •Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- •Currently using any over-the-counter stimulants and anorectics (diet pills)
- •Currently on fluoxetine (Prozac), bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL) or any other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- •Currently on NRT or bupropion (Zyban)
- •Current or past diagnosis of anorexia nervosa
- •Previous allergic response to fluoxetine, bupropion, or NRT
- •Previous failed quit attempt using NRT and bupropion in combination
- •Current suicidal ideation
- •Current or past psychosis, mania/hypomania, or any other Axis I or Axis II psychiatric diagnosis other than major depression and nicotine dependence
研究组 & 干预措施
Bupropion
干预措施: bupropion and smoking cessation behavioral intervention (Drug)
结局指标
主要结局
Can Depression and Smoking Cessation be Treated Simultaneously
时间窗: Dropouts over course of study
This was measured by the drop out rate during the study.
Hamilton Depression Scale Score
时间窗: baseline to week 10
Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.
Cessation of Smoking
时间窗: Week 10
Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.
次要结局
未报告次要终点
研究者
Alan Schatzberg
Professor
Stanford University