A randomized, controlled, open-label, 3-arm parallel group, single-center study to demonstrate exposure to selected HPHCs and to characterise the subjective effects related to smoking in Maori / Pacific Islander smokers switching to the iQOS, as compared to continuing to use conventional cigarettes and smoking abstinence (HARPE)

Optimal Clinical Trials0 个研究点目标入组 180 人开始时间: 2017年2月14日最近更新: 2020年1月13日

研究概览

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•1.Willing and able to comply with study procedures and provide written informed consent;
•2.Male or female, 19 to 75 years of age, inclusive;
•3.Participant ‘self-identifies’ as of Maori or Pacific Island ethnicity;
•4.Participant has smoked consecutively for at least 1 year prior to the Baseline visit;
•5.Participant smokes at least 10 commercially available conventional cigarettes or pouch tobacco cigarettes per day (no brand restrictions) for the last 4 weeks prior to both the Screening visit and Baseline visit;
•6.Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use adequate methods of contraception during the study.

•1.Participant plans to quit smoking within 8 weeks from the Baseline visit;
•2.Unwilling to accept interruption to conventional cigarette or pouch tobacco cigarette smoking for up to 8 weeks when being randomized to the iQOS arm or smoking abstinence arm;
•3.Use of nicotine replacement therapy (i.e. nicotine patches, gum and/or lozenges) within 4 weeks prior to both the Screening visit and Baseline visit;
•4.Female participants who are pregnant, breastfeeding or plan to become pregnant within the next 6 months;
•5.Participant is employed by the tobacco industry or is a first degree relative of a person employed by the tobacco industry;
•6.Participant is, in the opinion of the investigator, considered to be an unsuitable candidate for the study for any reason.

发起方

Optimal Clinical Trials