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. 2022 Jan 6;2022(1):CD013790. doi: 10.1002/14651858.CD013790.pub2

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
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
  • Currently smoke ≥ 15 cigarettes per day

  • Smoked cigarettes for past ≥ 10 years

  • Aged 28–55 years

  • Agree to refrain from alcohol for 24 hours before study visits

  • No intention to quit smoking within next month, but willing to switch to alternative tobacco product


Exclusion criteria
  • Medical conditions that were a safety concern or would interfere with study

  • BMI < 18.5 or ≥ 35.0 kg/m2

  • Use of nicotine‐containing products other than cigarettes in 6 months prior to screening

  • Use drugs or supplements likely to interfere with study

  • Positive alcohol or drug test

  • Past alcohol or drug problems

  • Given blood in past 30 days, or received blood in past 2 months

  • Pregnant or lactating

  • People of childbearing potential who did not agree to use contraception

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
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
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".
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.