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

NCT04521647.

Study name Effects of menthol in e‐cigarettes on smoking behaviors
Methods Randomized cross‐over
Setting: Connecticut Mental Health Center, USA
Participants Estimated enrolment 85
Inclusion criteria: ≥ 21 years, use combustible cigarettes
Exclusion Criteria: None
Interventions EC: type not stated
Arm 1: menthol flavour. Participants will receive 5% nicotine in an EC. Participants will receive 2 nicotine concentrations via EC. Each exposure will be 10 3‐sec puffs and ad libitum use.
Arm 2: tobacco flavour. Participants will receive 5% nicotine in an EC. Participants will receive 2 nicotine concentrations via EC. Each exposure will be 10 3‐sec puffs and ad libitum use.
Outcomes Baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure (plasma nicotine levels), 2 weeks (CO), 3 weeks,  5 weeks  (BP and heart rate)
Primary outcomes: Cigarette craving; plasma nicotine levels; carbon monoxide
Secondary outcomes: EC craving; irritation/harshness; liking of EC; coolness; nicotine withdrawal; stimulation; EC use; cigarette use. Other outcomes measured: heart rate, blood pressure, pulse oximetry 
Starting date Study start date: November 1 2020. Estimated completion date: July 2025
Contact information Asti Jackson, PhD 4752414904, asti.jackson@yale.edu
Notes New to 2022 update