None listed
Conditions
Brief summary
iQOS is a novel device which heats a specifically designed tobacco stick, known as a HeatStick, rather than burning the tobacco. In this way it offers smokers an alternative to conventional cigarettes. iQOS has been approved by the New Zealand regulatory authorities and is currently available on the market. The purpose of this study is to find out how the levels of harmful and potentially harmful constituents (HPHCs) in Maori/Pacific Islander smokers is different depending on if they smoke conventional cigarettes, use the iQOS or abstain from smoking. The study also aims to characterize the subjective effects of smoking in the Maori/Pacific Islander population when switching from conventional smoking to iQOS as compared to continuing with conventional smoking and smoking abstinence.
Interventions
Participants will be randomised into 3 different arms:
iQOS Arm: Participants randomised to this arm will be educated by the researcher for approximately 20 minutes (e.g. face-to-face) on the use of iQOS device and the participant tobacco diary. Each participant will be provided with two iQOS devices and two packs of iQOS HeatSticks at Baseline. The participant may choose their preferred iQOS HeatStick flavour from any HeatStick flavours commercially available in New Zealand. Use manual will be
Participants will be randomised into 3 different arms: iQOS Arm: Participants randomised to this arm will be educated by the researcher for approximately 20 minutes (e.g. face-to-face) on the use of iQOS device and the participant tobacco diary. Each participant will be provided with two iQOS devices and two packs of iQOS HeatSticks at Baseline. The participant may choose their preferred iQOS HeatStick flavour from any HeatStick flavours commercially available in New Zealand. Use manual will be provided to the participants. The iQOS device can be used as often as the participant desires and conventional cigarette smoking is allowed occasionally. All iQOS device and conventional cigarette use is to be logged in the diary. The duration of the intervention is 8 weeks. Conventional Cigarette Arm: Participants randomised to the conventional cigarette arm will not be supplied with conventional cigarettes or pouch tobacco. These participants will continue to smoke conventional cigarette or pouch tobacco of their preferred brand. Participants are not allowed to smoke during study assessments (including questionnaire completion). No restrictions on the frequency of conventional cigarette smoking apply. At Week 8, participants will be asked to take part in the "Treatment Extension" period on the use of the iQOS device as per the iQOS arm. All smoking activity will need to be logged in the tobacco diary. Smoking Abstinence Arm: Participants will be confined from Baseline through to Day 3 and will be supplied with nicotine patches plus nicotine lozenges or nicotine gum. The nicotine replacement therapy is to be used according to the product guidelines. At the end of Week 8, the participants in this arm will not be offered to switch to other trial arms. The researcher will provide further guidance on continuing smoking cessation as appropriate. An iQOS device is comprised of three main components - HeatStick, holder and charger. The iQOS HeatStick is inserted into the iQOS holder to pre-heat the device. Thereafter, the aerosol generated by the heating process is inhaled by placing the lips on the mouthpiece filter and drawing air through the iQOS HeatStick. During use, the iQOS HeatStick is heated according to a controlled temperature profile within the iQOS holder. The temperature is less than 350 degrees Celsius. At this temperature, the tobacco of the iQOS HeatStick is heated without combustion. The iQOS HeatStick is similar in basic design to a conventional cigarette, but is shorter, contains less tobacco material and has an additional filter section. The participants will be educated by the researcher on the day of randomisation. All manuals will be provided as well as an access to an online video tutorials. Adherence of participants to their treatment arms will be monitored through their tobacco diary.
Sponsors
Optimal Clinical Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed