An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 7-Day Point Prevalence Abstinence at Month 15
研究概览
简要总结
After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
- •Reported smoking 10 or more cigarettes per day for at least the prior year
- •Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
- •Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
- •Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment
排除标准
- •Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.
研究组 & 干预措施
Replapse Prevention Therapy
干预措施: NRT (Drug)
Replapse Prevention Therapy
干预措施: Bupropion SR 150mg bid (Drug)
Replapse Prevention Therapy
干预措施: Relapse Prevention-Oriented Cognitive Behavioral Therapy (Other)
结局指标
主要结局
7-Day Point Prevalence Abstinence at Month 15
次要结局
- 4-Week Continuous Abstinence at Month 15
研究者
A. Eden Evins
Director, Center for Addiction Medicine
Massachusetts General Hospital