CTIS2023-506787-13-00进行中（未招募）1 期
Evaluation of the effects of oral nicotine substitutes (1.5mg lozenge) on the craving in moderate smokers placed in non-smoking situations. A randomized, double-blind, placebo-controlled parallel groups trial. - V00018PC303
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations;, Negative antigenic test to SARs-CoV-2 or variants performed at Screening and Day 0., Male or female;, Aged of at least 18 years old;, With a BMI ranging between 18.5 and 29.5 kg/m2;, Moderate smoker (11-20 cigarettes/day) with a Fagerström score of 5 to 6;, Subjects with first item of the Fagerström score = 2 (time to first cigarette between 5 and 30 minutes after awakening);, Motivation for smoking cessation >7 on Richmond test at Screening and Day 0;, Negative serum ß-HCG test (female subject of childbearing potential only) performed at Screening and Negative urine ß-HCG test performed at Day 0 if the Screening serum ß-HCG test has been done more than 72 hours prior to Day 0;, For women of childbearing potential: use of an efficient contraceptive method (oral, intravaginal and transdermal combined hormonal contraception, IUD, implant, tubal surgery or barrier method);
排除标准
- •Subject with history of phenylketonuria, due to presence of aspartam;, Subject with history of angor pectoris, myocardial infarction or stroke in the 3 months before the trial;, Subject with history of epilepsy;, Subject with asthma or COPD;, Subject with Parkinson disease;, Subject presenting with hyposalivation (including dry mouth) or hypersialorrhoea;, Subject with oral irritation or any disorders of the oral mucosa (aphtha, ulceration, lichen planus, stomatitis, glossitis, pharyngitis);, Any other relevant medical history of major medical, psychiatric illness or surgery which in the judgement of the investigator put them at risk or will be likely to modify their handling in the study treatment;, Use any forms of NRT in the 3 months preceding the trial;, Use of e-cigarette or snuse (nicotine pouch) in the 3 months preceding the trial;, Use of any other treatment for smoking cessation in the past 3 months preceding the trial;, Hypersensitivity to peanut or soybean, due to presence of soya oil;, Regular use of sedatives, hypnotics, tranquilizers, antidepressant treatments or any other addictive agents (for alcohol, WHO rules to be applied. Alcohol abuse is defined as use of > 14 units per week [one unit of alcohol is equal to 240 mL beer (5 %) or 100 mL wine (12 %) or spirits (42.5 g of 40 % volume spirit)]);, Pregnant or breastfeeding women;, Subject with an addiction (exept nicotine) or under medication used for addiction;, Presence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule according to Investigator’s judgement; those conditions should be assessed with the subject before randomization in the trial;, Subject is a family member of the investigator or any associate, colleague and employee assisting in the study conduct (secretary, nurse, technician) or is otherwise in a position likely to represent a conflict of interest, the subject is only eligible if the informed consent has been sought by an appropriately qualified individual who is completely independent of this relationship;, Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, whichever is longer, before the first dose of study treatment;, Subjects who have forfeited their freedom by administrative or legal award or is under guardianship., Fructose intolerance due to presence of isomalt;, Hypersensitivity to nicotine or a component of the vehicle;, Subject with cardiac arrythmia, severe hypertension, unstable coronary disease;, Subject with cancer;, Subject with evolutive gastric or duodenal ulcer;, Subject with hyperthyroidism, diabetes or pheochromocytoma;, Subject with severe hepatic and/or renal insufficiency;
研究者
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