Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Smoking behavior (measured by automated topography)
研究概览
简要总结
Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.
详细描述
Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokes between 20 and 50 cigarettes per day
- •Diagnosis of schizophrenia or schizoaffective disorder
排除标准
- •If enrolled in the control group, must not be diagnosed with a psychiatric disorder
- •Currently dependent on alcohol or any drug (other than nicotine)
- •Currently trying to quit smoking
- •Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin
- •History of liver disease
- •History of heart attacks or chest pain
- •Allergic to adhesives
- •Pregnant or breastfeeding
研究组 & 干预措施
2
Transdermal nicotine, 21 mg
干预措施: 21 mg transdermal nicotine (Drug)
1
Transdermal nicotine, 42 mg
干预措施: Transdermal Nicotine Patch (Drug)
3
placebo patch
干预措施: placebo patch (Drug)
结局指标
主要结局
Smoking behavior (measured by automated topography)
时间窗: after 5 hrs abstinence
次要结局
- Nicotine withdrawal severity(after 5 hrs abstinence)
- Smoking urge(after 5 hrs withdrawal)
- Adverse events (measured by self-report throughout the study)(ongoing)
