Treating Tobacco Dependence in Smokers With Severe Mental Illness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 7-Day Point Prevalence Abstinence
研究概览
简要总结
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.
详细描述
At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
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
- 是
入选标准
- •have a severe mental illness diagnosis
- •be a daily smoker
- •be willing to reduce the number of cigarettes smoked per day leading to a quit attempt
- •want to try to quit smoking
- •be willing to use nicotine replacement therapy
- •be able to communicate in English
排除标准
- •anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months
- •pregnancy
- •taking Chantix or Clozapine
- •having a terminal illness
研究组 & 干预措施
Control
Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
干预措施: Information (Other)
Intervention
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
干预措施: Nicotine patch (Drug)
Intervention
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
干预措施: Nicotine lozenge (Drug)
Intervention
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
干预措施: Therapy (Behavioral)
Intervention
Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
干预措施: Information (Other)
结局指标
主要结局
7-Day Point Prevalence Abstinence
时间窗: 8 weeks and 6 months post baseline
To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment.
次要结局
- Smoking Reduction(8 weeks and 6 months post baseline)
- Quit Attempts(8 weeks and 6 months post baseline)