Safety and Tolerability of Varenicline When Used for Smoking Cessation/Reduction in Individuals With Severe and Persistent Mental Illness: An Open Label Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.
研究概览
简要总结
This is a 15 week trial to determine (1) the safety and tolerability of varenicline when used for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with varenicline affects the symptoms of schizophrenia.
详细描述
Researchers are looking to recruit a total of 50 subjects at Riverview and Forensic Psychiatric Hospitals who would like to reduce or quit smoking cigarettes. This open label pilot study will gather information regarding the safety and tolerability of varenicline in subjects who have been diagnosed with schizophrenia or schizoaffective disorder. Consenting subjects will be prescribed varenicline as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. The research team will meet with the subject once a week for twelve weeks and the subject will be interviewed and asked to complete questionnaires about his/her psychiatric symptoms, tobacco use and nicotine dependence. The measures used include the FTND, PANSS, CGI-I, CGI-S, ESRS, UKU, BARS, WSWS, QSU-brief, mCEQ, and the OAS-M. The CGI-SS will also be completed throughout the study as well as once weekly for three weeks following the completion of the study (Post-Study follow-up visits 1-3).
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with a diagnosis of schizophrenia or schizoaffective disorder
- •Individuals between the ages of 19 and 65 years of age
- •Individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
- •Individuals that are not expected to be discharged from hospital within 4 months.
排除标准
- •Clinically significant allergic reactions to the study medication
- •Clinically significant abnormalities in the screening laboratory values
- •Subjects at significant risk of self-harm
- •Previous treatment with varenicline
- •Women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
- •Men not using adequate contraception
- •Use of medications that might interfere with the study medication evaluation
- •Nicotine replacement
- •Nortriptyline
- •Clonidine
研究组 & 干预措施
1
Smoking cessation drug - varenicline
干预措施: Varenicline (Drug)
结局指标
主要结局
Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.
时间窗: 12 weeks
次要结局
- Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.(12 weeks)
研究者
Ric Procyshyn
Principle Investigator
University of British Columbia