ACTRN12607000086460招募中3 期
A phase III, single blind, randomised, cross-over trial of the effects of a novel nicotine replacement therapy (NicoNovum mouthspray and lozenge)in the treatment of withdrawal relief in smokers.
Professor Peter Hajek0 个研究点目标入组 52 人开始时间: 2007年1月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Smoke =15 cigarettes per day for the last year Smoke within 30 minutes of wakingSelf-report being in good health with verification by medical history. Be able to attend the study site for 4 weeks on the same day of the week. Be able to read and write English. Participants are capable of giving informed consent.
排除标准
- •Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition Diabetes mellitus Previous severe allergic reactionCurrent chemical dependence other than nicotine Current psychiatric disorder. Chronic oral disorder. Pregnant (will have negative urinary dipstick for beta - human chorionic gonadotropin (ßHCG) Breast feeding. Weight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolic Current use of nicotine products other than cigarettes Any condition that would preclude proper use of nicotine gum. Current use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drug. Participants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (exhaled carbon monoxide (CO) verified)
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