Nides 2014.
Study characteristics | ||
Methods | Design: Open‐label non‐comparative study Recruitment: Study site database and community advertisements Setting: Clinical Trials Unit, USA Study start date: April 2013; Study end date: 10 July 2013 |
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Participants | Total N: 29 Inclusion criteria:
Exclusion criteria:
Exclusion criterion: EC within the previous 14 days; use of NRT in last 30 days 44% women; mean age 43; mean cpd 20.1; mean FTND 4.5 Motivated to quit: no E‐cigarette use at baseline |
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Interventions |
EC: Cig‐a‐like Participants attended 3 clinic visits at 1‐week intervals Visit 1: Baseline Visit 2: Provided with 1st generation type ‐ 'NJOY® King Bold' (NJOY, Inc. Scottsdale, AZ), with 26 mg nicotine. Used ad libitum for 20 minutes in the clinic, then ad libitum use over the next week. Recorded use of regular cigarettes and puffs on EC Visit 3: Participants abstained from all sources of nicotine for 12 hours prior to visit |
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Outcomes | Adverse events | |
Study funding | Funding for this study was provided by NJOY, Inc., Scottsdale, AZ | |
Author declarations | Dr Nides has received compensation from NJOY, Inc. and GlaxoSmithKline. Dr Leischow has received compensation from GlaxoSmithKline, Pfizer, and Cypress Bioscience. Mr Simmons and Ms Bhatter have no conflict of interest to report | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Prospective cohort |
Allocation concealment (selection bias) | High risk | Not randomized |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants dropped out between visits 1 and 2 |
Selective reporting (reporting bias) | Low risk | Planned comparisons reported |