Medicinal Nicotine for Preventing Cue Induced Craving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Craving Symptom Severity Score Assessed Via Questionnaire
研究概览
简要总结
The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoking a minimum number of cigarettes per day
- •General good health
排除标准
- •unstable medical or psychiatric conditions
- •history of severe motion sickness (due to virtual reality equipment used to present cues)
- •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 4 mg prior to cue exposure
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
干预措施: Nicotine lozenge 4 mg (Drug)
Placebo lozenge prior to cue exposure
Placebo lozenge is used 15 minutes prior to smoking cue exposure
干预措施: Placebo lozenge (Drug)
Control condition: Lozenge after cue exposure
Lozenge is used immediately after smoking cue exposure
干预措施: Nicotine lozenge 4 mg (Drug)
结局指标
主要结局
Craving Symptom Severity Score Assessed Via Questionnaire
时间窗: approximately 15 minutes
Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.
Withdrawal Symptom Severity Score Assessed Via Questionnaire
时间窗: approximately 15 minutes
Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.
次要结局
未报告次要终点