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 |