NCT05023096.

Study name	Potential effects of electronic nicotine delivery system flavor regulations on African American menthol smokers (RVA Flavors)
Methods	RCT Virginia Commonwealth University, USA
Participants	Estimated enrolment: 210 Inclusion criteria: 21+ years; identify as Black/African‐American (single or multi‐race); used ≥ 5 cigarettes per day for ≥ 1 year (biochemically confirmed); regular cigarette brand menthol or mint flavoured; EC use in the past 30 days; no intent to quit smoking in the next 6 months; previous quit attempt using evidence‐based method; mobile phone, willing to receive calls/text Exclusion criteria: unwilling to use EC; report other tobacco use > 10 days in past 30 other than combustible cigarettes; unstable or significant medical condition in the past 12 months; > 15 days of marijuana or other illegal drug use in the past 30 days; pregnancy/breastfeeding
Interventions	EC: type not stated Arm 1: Menthol + tobacco. Both menthol and tobacco flavoured liquids for EC are available to choose from. Arm 2: Tobacco ‐ only tobacco flavoured liquid is available for EC. Arm 3: Unflavoured ‐ only unflavoured liquid is available for EC. Participants are instructed to smoke their usual brand of menthol cigarettes normally for 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 EC flavour conditions, all contain 5% nicotine (menthol + tobacco, tobacco, unflavoured) with equal probability and provided with a supply of their condition‐specific EC and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
Outcomes	Week 1, week 6 Change in: average daily cigarette use; carbon monoxide exposure; urinary NNAL; urinary proplyne glycol exposure; average daily ENDS use Willingness to substitute from cigarettes to EC (ENDS); measure of substitution for condition‐specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced. Willingness to pay for ENDS (week 6); willingness to pay for condition‐specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.
Starting date	Study start date: April 14 2022. Estimated primary completion date: June 2024
Contact information	Andrew J. Barnes, PhD 804‐827‐4361, abarnes3@vcu.edu Caroline O. Cobb, PhD, cobbco@vcu.edu
Notes	New to 2022 update