Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial. - Rapid Reduction Study

niversity of Birmingham0 个研究点目标入组 700 人开始时间: 2009年1月20日最近更新: 2019年11月25日

适应症

试验速览

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•1.males and females 18 years or older,
•2.smokes at least 15 cigarettes or 12.5g of loose tobacco daily as roll your own cigarettes, or blows 15 or15ppm or above on CO recording.
•3.willing to stop smoking completely in two weeks
•4.evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate and be randomised to either arm
•5.be willing and able to comply with all study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. currently using other NRT, bupropion, nortriptyline, mecamylamine, reserpine, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture),
•2. unstable angina pectoris, myocardial infarction, or cerebrovascular accident during the last 3 weeks,
•3. severe cardiac arrhythmia
•4. currently uncontrolled hyperthyroidism
•5. active phaeocromocytoma
•6. pregnancy, lactation or intended pregnancy
•7. suspected alcohol or drug abuse
•8. participation in other medicinal trials within the last three months and during study participation,
•9. previously had severe skin reactions to nicotine patches or severe eczema or other skin diseases that make patch use hazardous or undesirable.
•10. a severe acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

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