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. 2016 Sep 13;2016(9):CD010216. doi: 10.1002/14651858.CD010216.pub3
Trial name or title 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 1) Switch to standard nicotine EC use for 8 wks
2) Switch to ECs with same nicotine but very low non‐nicotine alkaloid levels
3) Switch to ECs with very low nicotine and non‐nicotine alkaloids
Outcomes Primary: CO levels at 8 wks
Secondary: EC use, EC solution use, cig use, at 8 wks
Starting date May 2016
Contact information Jed Rose
Notes "This is not a smoking cessation study; smokers will not be asked to quit smoking, and e‐cigarettes will not be used as a medical device or therapy."