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. 2022 Nov 17;2022(11):CD010216. doi: 10.1002/14651858.CD010216.pub7

NCT02004171.

Study name Electronic cigarettes or nicotine inhaler for smoking cessation
Methods Randomized controlled trial, open‐label safety/efficacy study
Setting and recruitment not specified, USA
Participants 40 participants
Inclusion criteria:
  • 18‐60 years old

  • Meet DSM‐IV criteria for nicotine dependence

  • Seeking treatment for smoking cessation

  • Smoking at least 15 cpd


Exclusion criteria:
  • DSM‐IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder

  • Current diagnosis of major depressive disorder

  • Current diagnosis for other psychiatric disorders that may require intervention over course of study

  • Receiving treatment for nicotine dependence

  • Pregnancy, lactation, or chance of pregnancy

  • Unstable medical condition

  • Substance abuse diagnosis

  • Use of cannabis or alcohol on more than 20 days in past 30 days

  • Suicide risk

Interventions 4 weeks:
  • ECs (2nd generation) with 24 mg nicotine cartridges, 1‐2 cartridges daily

  • Nicotine inhaler with 10 mg cartridges, max 16 cartridges per day

Outcomes Over 4 weeks:
  • cpd

  • Withdrawal

  • Benefits from smoking cessation (breathing, sense of taste and smell, physical fitness)

  • Adverse events

  • BMI

Starting date December 2013
Contact information Barney Vaughan, vaughan@nyspi.columbia.edu
Notes