Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
研究概览
简要总结
This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely.
This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.
详细描述
This study will measure mood effects and rapid anti-craving effects of varenicline in psychiatric inpatients. Patients will be offered to participate in the trial if they wish to stop smoking or wish to decrease nicotine cravings while in the hospital. They will not be able to use nicotine replacement products when taking varenicline.
Patients will be assessed with the QIDS-SR16, Minnesota Nicotine Withdrawal Scale as well as the Frequency, Intensity, and Burden of Side Effects (FISER) at baseline and daily during the trial; patients will be asked to enroll for the duration of their hospitalization. Patients will be assessed as to whether they wish to continue varenicline post-discharge.
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
- •Admission to Butler Hospital during study period.
- •Current tobacco users ages 18-
- •Able to give written, informed consent.
排除标准
- •Past adverse reaction to varenicline.
- •Treatment with varenicline on admission to Butler Hospital.
- •Renal failure or dialysis
- •(3) Current pregnancy or breastfeeding.
结局指标
主要结局
improvement in Quick Inventory of Depressive Symptoms (QIDS-SR)
时间窗: duration of hospitalization
improvement in Minnesota Nicotine Withdrawal Scale
时间窗: days (duration of hospitalization)
次要结局
- no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI)(duration of hospitalization)