Meier 2017.
Study characteristics | ||
Methods | Design: Randomized cross‐over trial (e‐cig vs placebo) Recruitment: via local media outlets Setting: Community, USA Study start date/Study end date: Not specified. |
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Participants | Total N: 24 Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: No 25% women; mean age 48.5; mean cpd 16.3; FTND not reported Motivated to quit: No (eligibility criteria was to not want to quit in next 30 days) E‐cigarette use at baseline: 8/24 (33%) had previously tried an EC, avg 9.4 months since last use, avg length of use 3.6 days |
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Interventions |
EC: Cig‐a‐like
Smoked “as usual” for 1 week followed by 2 weeks of either placebo or active 1st generation EC BluCig starter kit with up to 7 cartridges (prefilled, with either active 16 mg or 0 mg nicotine solution) Participants were instructed “this e‐cig may or may not contain nicotine; we ask that you try it at least once, but use it however you like; smoke regular cigarettes as you wish.” Shown how to charge the device and sampled the product during the visit. Provided a handout on how to use the product (e.g., switching cartridges) and general information about ECs |
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Outcomes | 1 week in each condition, in person Adverse events and biomarkers:
Other outcomes measured:
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Study funding | “..supported by grants P01 CA138389, P30 CA138313 (Hollings Cancer Center Support Grant) from the National Cancer Institute of the National Institutes of Health and UL1 TR000062 from the National Center for Advancing Translational Science of the National Institutes of Health. BWH was supported by K12DA031794” | |
Author declarations | “KMC has received grant funding from the Pfizer, Inc., to study the impact of a hospital‐based tobacco cessation intervention. He also receives funding as an expert witness in litigation filed against the tobacco industry. We have no other declarations of interests to declare” | |
Notes | New for 2020 update. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Participants were randomized to receive either an active or placebo EC first”, no further information provided. |
Allocation concealment (selection bias) | Unclear risk | Refer to 'Random sequence generation'. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “Participants and research staff conducting sessions were blinded to dose. All cartridges were pre‐loaded by the manufacturer. Labeling was removed by a research team member not involved in participant contact to mask placebo versus active ECs. We restricted flavor options to regular tobacco flavor or menthol to most closely match usual cigarette brand flavor profile and reduce unwanted variance in product” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Participants and research staff conducting sessions were blinded to dose. All cartridges were pre‐loaded by the manufacturer. Labeling was removed by a research team member not involved in participant contact to mask placebo versus active ECs. We restricted flavor options to regular tobacco flavor or menthol to most closely match usual cigarette brand flavor profile and reduce unwanted variance in product” |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not specified |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |