NCT02357888已完成2 期
Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
研究概览
简要总结
The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female aged 18 to 64 years
- •Smoking ≥ 20 cigarettes/day continuously for the last two years
- •With a first cigarette smoked within 30 min after waking
- •Not currently in the process of quitting smoking
排除标准
- •Related to pathologies
- •Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
- •Hyposalivation or asialia
- •Intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (CO)
- •Related to treatments
- •Use of antidepressants within the last three months
- •Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
- •Routine use of tobacco other than cigarettes
- •Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
- •History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
- •Intolerance to fructose
- •History of phenylketonuria (aspartame)
- •For women of childbearing potential:
- •Is pregnant or in post-partum period or a nursing mother
研究组 & 干预措施
Sequence 1
Experimental
Treatment group sequence: Test Product on Day 1 and Placebo on Day 2
干预措施: Placebo (Drug)
Sequence 1
Experimental
Treatment group sequence: Test Product on Day 1 and Placebo on Day 2
干预措施: V0018 (Drug)
Sequence 2
Experimental
Treatment group sequence: Placebo on Day 1 and Test Product on Day 2
干预措施: V0018 (Drug)
Sequence 2
Experimental
Treatment group sequence: Placebo on Day 1 and Test Product on Day 2
干预措施: Placebo (Drug)
结局指标
主要结局
Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
时间窗: 15 minutes
Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect.
次要结局
未报告次要终点
研究者
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