Effects of rTMS on Smoking Cessation and Cognitive Outcomes in Outpatients With Schizophrenia Treated With Transdermal Nicotine Patch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm.
研究概览
简要总结
Patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. The development of novel and more effective treatments for tobacco dependence in this population is thus needed. This study will test the hypothesis that repetitive transcranial magnetic stimulation (rTMS) may facilitate smoking cessation with the transdermal nicotine patch (TNP) in patients with schizophrenia motivated to quit smoking. A total of N=40 smokers with schizophrenia would be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatments for four weeks. All subjects would receive TNP (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for enhancing smoking cessation rates in smokers with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- •Smoking at least 10 cigarettes per day and a Fagerstrom score of at least
- •Willing to quit smoking in the next 30 days.
排除标准
- •Active alcohol or illicit drug abuse or dependence in the past 3 months
- •A history of seizures, head trauma or space occupying lesions.
- •A history of alcohol or illicit drug abuse in the past 6 months.
- •Intolerance of the nicotine patch or its excipients
- •Evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation.
- •Females who are pregnant.
研究组 & 干预措施
1
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Procedure)
2
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) (Procedure)
结局指标
主要结局
Smoking abstinence (7-day point prevalence) at trial endpoint (Days 63-70) as assessed by self-reported smoking abstinence plus Expired Breath Carbon Monoxide Level <10ppm.
时间窗: trial endpoint
次要结局
- P50/NI, N-Back and VSWM Working Memory Performance(intermittent)
- Tobacco Craving (Tiffany QSU) and Withdrawal (Minnesota NMS)(intemittent)
- Expired Breath Carbon Monoxide Levels(intermittent)
研究者
Tony George
Principal Investigator
Centre for Addiction and Mental Health