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

NCT02590393.

Study name The role of nicotine and non‐nicotine alkaloids in e‐cigarette use and dependence
Methods Randomized parallel‐assignment double‐blind trial
Setting: Smoking research clinic, USA
Recruitment: volunteers
Participants Estimated enrolment: 375
Inclusion criteria:
  • Have no known serious medical conditions

  • Are 18 ‐ 65 years old

  • Smoke an average of at least 10 cpd

  • Have smoked at least 1 cumulative year

  • Have an expired air CO reading of at least 10 ppm

  • Are able to read and understand English


Exclude if: multiple, related to baseline health status
Interventions
  • Switch to standard nicotine EC use for 8 wks

  • Switch to ECs with same nicotine but very low non‐nicotine alkaloid levels

  • Switch to ECs with very low nicotine and non‐nicotine alkaloids

Outcomes Primary:
  • CO levels at 8 wks


Secondary:
  • EC use

  • EC solution use

  • cigarette use, at 8 wks

Starting date May 2016
Contact information Jed Rose
Notes "This is not a smoking cessation study; People who smoke will not be asked to quit smoking, and e‐cigarettes will not be used as a medical device
or therapy."