A randomized study in Maori / Pacific Islander smokers comparing exposure to selected harmful and potentially harmful constituents (HPHCs) of those switching to the iQOS device, continuing with conventional cigarette smoking and smoking abstinence.

Not Applicable

Withdrawn

• Conditions: Smoking; Public Health - Other public health; Mental Health - Addiction

• Registration Number: ACTRN12617000232336
• Lead Sponsor: Optimal Clinical Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the levels of 5 selected biomarkers of exposure to HPHCs in Maori / Pacific Islander smokers switching from conventional cigarettes to iQOS as compared to Maori / Pacific Islander smokers continuing to smoke conventional cigarettes and smoking abstinence after 8 weeks of use. The biomarkers that will be assessed from urine samples collected over 8 weeks are S-PMA (Benzene), MHBMA (1,3-Butadiene), total NNAL and cotinine levels and quantitative breath CO testing.<br><br>[After 8 weeks of iQOS device use.]