Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 1.5 mg Nicotine Lozenge on Smoking Craving
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 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 after administration of V0018 1.5 mg compared to placebo in healthy moderately dependent 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 ≥ 10 cigarettes/day and < 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
Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
干预措施: V0018 (Drug)
Sequence 1
Treatment group sequence: Test Product (V0018) on Day 1 and Placebo on Day 2
干预措施: Placebo (Drug)
Sequence 2
Treatment group sequence: Placebo on Day 1 and Test Product (V0018) on Day 2
干预措施: V0018 (Drug)
Sequence 2
Treatment group sequence: Placebo on Day 1 and Test Product (V0018) 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