Oncken 2015.
Study characteristics | ||
Methods | Design: Randomized cross‐over study Recruitment: Newspaper advertisements, radio announcements, and from local general medicine practices Setting: Lab‐based study, Connecticut, USA Study start date: October 2012; Study end date: June 2015 |
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Participants | Total N: 27 Inclusion criteria:
Exclusion criteria:
45% women; mean age 42; 70% white; 15% Hispanic, 15% black; mean cpd 16; 45% had tried EC at baseline, 50% smoked menthol cigarettes Motivated to quit: No E‐cigarette use at baseline: Not specified |
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Interventions |
EC: Cig‐a‐like Prescribed Joye eGo‐C (www.joyetech.com) and e‐Juice (18 mg/mL nicotine) procured from American eLiquid (www.americanliquid.com) Cross‐over study between menthol‐flavored and non‐menthol tobacco‐flavored EC. Requested not to smoke their regular cigarettes during study period, but most (60%) reported intermittently smoking cigarettes during study |
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Outcomes | Follow‐up at 1 wk and 2 weeks BP, heart rate, body plethysmography, static lung volumes and airways resistance (Raw) and specific conductance (sGaw) – taken at lab visits after abstaining from EC for at least 2 hrs, then taken again after inhaling EC and repeated 5 mins later Adverse events also reported but method for measuring not stated Also measured nicotine concentrations, rates of cigarette and EC use |
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Study funding | This project was supported by Academic Enhancement funds from the Department of Medicine at the University of Connecticut Health Center (to CO) and the Clinical Research Center at the University of Connecticut Health Center | |
Author declarations | CO is currently receiving study medication (nicotine inhaler and placebo) from Pfizer pharmaceuticals for an NIH funded of nicotine inhaler for smoking cessation during pregnancy | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not stated; Quote: "Subjects were then randomly assigned to use the menthol or plain e‐cigarette cartridge for one week, switching to the other cartridge for the second week" |
Allocation concealment (selection bias) | Unclear risk | No detail given |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No detail given on blinding but equal levels of support between arms, so performance bias judged unlikely |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Some subjective outcomes but equal levels of support between arms so differential misreport judged unlikely |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20/27 followed up |
Selective reporting (reporting bias) | Unclear risk | Unable to determine prespecified outcomes |