Very Low Nicotine Cigarettes in Smokers With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of cigarettes smoked per day
研究概览
简要总结
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •Schizophrenia, schizoaffective disorder or bipolar disorder
- •Smoke an average of at least 10 cigarettes per day for at least 1 year
- •Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2)
排除标准
- •Pregnant or nursing
- •Seeking treatment for smoking
- •Medical contraindications
研究组 & 干预措施
0.8 mg nicotine with 10.5 mg tar
SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)
干预措施: standard nicotine content cigarettes (Other)
0.03 mg nicotine with 9 mg tar
SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar
干预措施: Very low nicotine content cigarettes (Other)
结局指标
主要结局
Number of cigarettes smoked per day
时间窗: End of 6 week intervention
次要结局
未报告次要终点
研究者
Jennifer Tidey
Principal Investigator
Brown University