Tricker 2012c.
Study characteristics | ||
Methods | Design: RCT Study dates: not reported Recruitment: no information Location: Belfast, UK Setting: confinement in‐clinic setting |
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Participants | Number randomised: 160 Characteristics: 50.0% women; mean age 28.7 years; all participants smoked ≥ 10 cigarettes per day; mean FTND score 5.2 Specialist population: aged 19–50 years Inclusion criteria
Exclusion criteria
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Interventions | Randomised (7:7:7:7:4 ratio) to use a EHCSS‐K6 electronic HTP, EHCSS‐K3 electronic HTP, continue smoking Marlboro cigarettes, switch to Lark1 cigarettes, or become abstinent K6 heated tobacco arm Device heating method: electronic Device name: EHCSS‐K6, precursor to THS marketed under brand name IQOS Device manufacturer: PMI Other instructions and details: participants were given tobacco sticks Behavioural support: none mentioned Instructions for smoking cessation/switching: switch entirely to heated tobacco use for study period K3 heated tobacco arm Device heating method: electronic Device name: EHCSS‐K3, precursor to THS marketed under brand name IQOS Device manufacturer: PMI Other instructions and details: participants were given tobacco sticks Behavioural support: none mentioned Instructions for smoking cessation/switching: switch entirely to heated tobacco use for study period Marlboro cigarette smoking arm Other instructions and details: participants were given Marlboro cigarettes Behavioural support: none mentioned Instructions for smoking cessation/switching: continue smoking Marlboro cigarettes for study period Lark1 cigarette smoking arm Other instructions and details: participants were given Lark1 low machine yield cigarettes Behavioural support: none mentioned Instructions for smoking cessation/switching: switch to smoking Lark1 cigarettes for study period Abstinence arm Behavioural support: none mentioned Instructions for smoking cessation/switching: do not smoke cigarettes during study period |
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Outcomes | Follow‐up time points: 1 week (8 days) Abstinence outcomes: N/A Safety outcomes: biomarkers of exposure to toxins and carcinogens; biomarkers of harm; adverse events; serious adverse events Prevalence/sales outcomes: N/A |
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Notes |
Funding source Tobacco industry funded: quote: "The work reported in all eight parts of this supplement was funded by PMI R&D". Author conflicts of interest Quote: "All authors are or were Philip Morris International (PMI) R&D employees or worked for PMI R&D under contractual agreements". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcomes were biological. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on attrition. |
Selective reporting (reporting bias) | Unclear risk | No trial registration or analysis plan. |
BMI: body mass index; FEV1: forced expiratory volume in one second; FTND: Fagerstrom Test for Nicotine Dependence; FVC: forced vital capacity; HTP: heated tobacco product; N/A: not available/applicable; PMI: Philip Morris International; RCT: randomised controlled trial.