Nicotine Delivery Systems: Research and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Quit Attempts, Use of NRTs, Preference Among NRTs
研究概览
简要总结
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.
Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.
详细描述
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be enrolled veteran who smokes.
排除标准
- •Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication)
- •other criteria as determined by PI and study physicians
- •reactions to menthol (inhaler) or to aspartame (lozenge)
研究组 & 干预措施
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
干预措施: Nicotine gum - 2 mg and 4 mg (Drug)
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
干预措施: Nicotine lozenges - 2 mg and 4 mg (Drug)
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
干预措施: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing (Drug)
NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
干预措施: Computer learning (Other)
结局指标
主要结局
Quit Attempts, Use of NRTs, Preference Among NRTs
时间窗: At testing, at follow-up
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
次要结局
未报告次要终点