Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)
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
研究概览
简要总结
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.
详细描述
There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).
Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.
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, 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
- •Diagnosed with schizophrenia or schizo-affective disorder
- •Smokes between 20 and 50 cigarettes per day
- •Moderate to high nicotine dependence score
- •Interest in quitting smoking
排除标准
- •Currently trying to quit smoking
- •Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
- •Alcohol or drug use disorders
- •Requires certain medications
- •Pregnant or breastfeeding
研究组 & 干预措施
1
300 mg/day bupropion-sr
干预措施: 300 mg/day bupropion-sr (Drug)
2
0 mg bupropion-sr
干预措施: 0 mg/day bupropion-sr (Drug)
结局指标
主要结局
Smoking behavior
时间窗: after 5 hrs abstinence
次要结局
- urge to smoke(after 5 hrs abstinence)
- nicotine withdrawal symptoms(after 5 hrs withdrawal)
- Adverse events(ongoing)