Ogden 2015.
Study characteristics | ||
Methods | Design: RCT Study dates: November 2007 to November 2009 Recruitment: no details Location: USA (Idaho, Texas, Florida, and Oregon) Setting: ambulatory setting, with in 24‐hour of confinement in‐clinic at weeks 0, 12, and 24 |
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Participants | Number randomised: 131 Characteristics: 49.6% women; mean age 42 years; no information on mean cigarettes smoked per day or FTND score Specialist population: aged 28–55 years Inclusion criteria
Exclusion criteria
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Interventions | Randomised (1:1:1 ratio) to use a carbon tip HTP, snus, or continue smoking cigarettes Heated tobacco arm Device heating method: carbon tip Device name: Eclipse Device manufacturer: R.J Reynolds (BAT) Other instructions and details: provided with heated tobacco sticks, with choice of menthol or non‐menthol products Behavioural support: provided information about HTP. Compensated for recording use of nicotine and tobacco products in interactive voice recording system diary Instructions for smoking cessation/switching: switch entirely to Eclipse for study period Snus arm Other instructions and details: provided snus with 3 flavour options (spice, original, and frost) Behavioural support: provided information about snus. Compensated for recording use of nicotine and tobacco products in interactive voice response system diary Instructions for smoking cessation/switching: switch to snus use for study period Cigarette smoking arm Other instructions and details: provided with ultra‐low machine yield cigarettes, with choice of menthol or non‐menthol cigarettes Behavioural support: compensated for recording use of nicotine and tobacco products in interactive voice recording system diary Instructions for smoking cessation/switching: switch to smoking ultra‐low machine yield cigarettes |
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Outcomes | Follow‐up time points: 12 and 24 weeks Abstinence outcomes: N/A Safety outcomes: biomarkers of toxicant and carcinogen exposure; adverse events; serious adverse events Prevalence/sales outcomes: N/A |
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Notes |
Funding source Tobacco industry funded: quote: "All authors are current employees of RAI Services Company or R.J. Reynolds Tobacco Company". Author conflicts of interest Quote: "All authors are current employees of RAI Services Company or R.J. Reynolds Tobacco Company". |
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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) | Low risk | Randomised using an Interactive Voice Response System. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcomes were biological. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition 25% overall, but differed by < 20% points across groups (23% in heated tobacco, 33% in snus, and 21% in cigarette arms). |
Selective reporting (reporting bias) | Unclear risk | No preregistered analysis plan, as trial registration was added several years after data were collected. |