TIMEPOINT | Intake | Week − 1 | Week 0 | Week 2 | Week 4 | Week 6 | Week 8 | Week 12 |
---|---|---|---|---|---|---|---|---|
Enrollment | ||||||||
Eligibility screening | x | |||||||
Informed Consent | x | |||||||
Randomization | x | |||||||
Interventions | ||||||||
Usual brand menthol cigarettes available | x | |||||||
Cigarettes and e-cigarettes available by regulatory scenario: (A) no menthol ban, (B) menthol ban in cigarettes only, or (C) menthol ban in both cigarettes and e-cigarettes | x | x | x | x | x | |||
Assessments | ||||||||
Demographics | x | |||||||
Tobacco use history | x | |||||||
Medical history interview | x | |||||||
Mood (anxiety GAD-7a, depression PHQ-8b) | x | |||||||
Quality of lifec | x | x | ||||||
Racial trauma and discrimination (TSDSd) and ethnic identity (MEIMe) | x | |||||||
Timeline follow-back interviewf (cigarettes, e-cigarettes, cannabis and other tobacco products) | x | x | x | x | x | x | x | x |
Nicotine dependence (cigarette and e-cigarette PROMIS measures)g,h | x | x | x | x | ||||
Wisconsin Inventory of Smoking Dependence Motives (WISDM-37)i | x | x | ||||||
Time to first cigarette (FTND)j | x | x | x | x | x | |||
Cigarette quitting motivation and confidencek | x | x | x | |||||
Product satisfaction (Modified cigarette evaluation scale, modified e-cigarette evaluation scale)l,m | x | x | x | x | x | |||
Product cravingn (cigarette, e-cigarette) | x | x | x | x | x | x | ||
Nicotine withdrawal (Minnesota Nicotine Withdrawal Scaleo) | x | x | x | x | x | x | ||
Health and safety assessment | x | x | x | x | x | x | x | |
Protocol adherence measures (spent cigarette filters, e-cigarette pods, use of other mentholated products) | x | x | x | x | x | x | x | |
Biochemical measures | ||||||||
Urine pregnancy test | x | x | x | x | x | x | x | |
Urine biomarkers (cotinine, total nicotine equivalents, menthol glucuronide) | x | x | x | x | ||||
Expired breath carbon monoxide (CO) | x | x | x | x | x | x | x | x |
Spirometer lung function test | x | x | x | x | x | x | x |