ACTRN12606000489594尚未招募不适用
A phase III, single blind, randomised, cross-over trial of the effects of a novel nicotine replacement therapy (NicoNovum pouch)in the treatment of withdrawal relief in smokers.
Professor Peter Hajek0 个研究点目标入组 36 人开始时间: 2006年11月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
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 historyBe able to attend the study site for 4 weeks on the same day of the week. Be able to read and write EnglishParticipants 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 disorderChronic oral disorderPregnant (will have negative urinary dipstick for ßHCG)Breast feedingWeight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolicCurrent use of nicotine products other than cigarettesAny condition that would preclude proper use of nicotine gumCurrent use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drugParticipants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (CO verified)Participants who wish to stop smoking during the 4-week study period. Please note, for those who wish to cease smoking after the study, assistance (pharmacological treatment and behavioural support) will be provided).
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icoNovum Evaluation of Withdrawal Relief Study Part 2SmokersPublic Health - Health service researchMental Health - AddictionACTRN12607000086460Professor Peter Hajek52
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