Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Number of Participants Who Dropped Out of Study as a Measure of Adherence
研究概览
简要总结
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
详细描述
To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.
Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •Age 18-65
- •Less than 16 years of education
- •Able to understand, and sign consent
- •Smoke >4 cigarettes/day for at least a year
- •No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
- •Plan to live in local area for next 8 months
- •Able to read and write in English
- •Women not pregnant and taking steps to avoid pregnancy
排除标准
- •College graduate
- •Use of psychotropic drugs
- •Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
- •Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
- •Currently pregnant or nursing
- •Uncontrolled serious psychotic illness or substance abuse
- •History of difficulties providing blood samples-fainting, poor veins, anxiety
研究组 & 干预措施
Reduced Nicotine Content Cigarettes
the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.
干预措施: Reduced Nicotine Content Cigarettes (Drug)
Same Nicotine Content Cigarettes
The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)
干预措施: Same Nicotine Content Cigarettes (Drug)
结局指标
主要结局
Number of Participants Who Dropped Out of Study as a Measure of Adherence
时间窗: 18 weeks
Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.
次要结局
- Predictors of Participant Dropout(18 weeks)
- Cigarettes Per Day(18 weeks)
- Nicotine Exposure(18 weeks)
- Smoke Exposure(18 weeks)
- Perceived Stress(18 weeks)
- Cortisol(15 weeks)
研究者
Jonathan Foulds
Professor
Milton S. Hershey Medical Center