Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Craving
研究概览
简要总结
The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Smoking an average of at least 10 cigarette per day
- •General good health
排除标准
- •unstable medical or psychiatric conditions
- •history of severe motion sickness
- •women who are pregnant or breast feeding
- •The investigators will evaluate if there are other reasons why someone may not participate
研究组 & 干预措施
Nicotine Lozenge Immediately Prior to Stress task
Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session
干预措施: Nicotine lozenge (Drug)
Nicotine lozenge 10 Minutes prior to Stress task
Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session
干预措施: Nicotine lozenge (Drug)
Nicotine lozenge 20 minutes prior to Stress task
Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session
干预措施: Nicotine lozenge (Drug)
Nicotine Lozenge 30 minutes prior to stress taks
Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session
干预措施: Nicotine lozenge (Drug)
结局指标
主要结局
Craving
时间窗: Baseline, 6 months
The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.
Nicotine Withdrawal Symptoms
时间窗: 5 to 35 minutes
The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.
次要结局
未报告次要终点