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. 2020 Oct 14;2020(10):CD010216. doi: 10.1002/14651858.CD010216.pub4

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
Participants Total N: 29
Inclusion criteria:
  • Age 18 ‐ 65 years

  • Good health

  • BMI 18 ‐ 35

  • Smoking 10+ cpd

  • CO > 10 ppm


Exclusion criteria:
  • Pregnancy or breastfeeding

  • Other drug dependency

  • Use of any psychiatric or opioid medications

  • EC within the previous 14 days

  • Use of NRT in last 30 days

  • Want to reduce or quit smoking within the next 30 days


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
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
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