A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol

• Published in: BMC psychiatry Vol. 24; no. 1; pp. 201 - 11
• Main Authors: Bold, Krysten W, Sharma, Akshika, Haeny, Angela, Gueorguieva, Ralitza, Buta, Eugenia, Baldassarri, Stephen, Lempert, Lauren, Krishnan-Sarin, Suchitra, O'Malley, Stephanie
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 12.03.2024; BioMed Central; BMC
• Subjects: Adult; African Americans; cigarette; Cigarette smoking; Cigarette Smoking - epidemiology; Clinical trials; Drug dependence; e-cigarette; Electronic cigarettes; Electronic Nicotine Delivery Systems; FDA approval; Federal regulation; Flavor; Flavoring Agents; Health behavior; Humans; Menthol; menthol ban; Nicotine; policy; Public health; Randomized Controlled Trials as Topic; Recruitment; Smoking; Standardization; Study Protocol; Tobacco; Tobacco Control; Tobacco Products; tobacco regulatory science; United States; United States; United States > US; e-cigarette; cigarette; tobacco regulatory science; menthol ban; policy
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-024-05619-0

Menthol cigarette use remains a large public health problem and disproportionately affects Black adults in the United States. The Food and Drug Administration has proposed prohibiting menthol flavor in cigarettes to protect public health. However, e-cigarettes are available in menthol flavor and are a popular alternative product adults might switch to if menthol is prohibited in cigarettes. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes could impact cigarette use among adults who smoke menthol cigarettes. We will recruit 150 adults who currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory scenarios. We will recruit equal numbers of participants identifying as Black vs. non-Black and will stratify randomization by race. To promote standardization and adherence, cigarette and e-cigarette products will be provided for 8 weeks based on the assigned condition: (A) no menthol restriction (menthol cigarette and menthol flavored e-cigarette), (B) menthol prohibited in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), (C) menthol prohibited in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up visit will occur at week 12 to assess tobacco use status. The study aims are to (1) examine the impact of prohibiting menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) investigate whether outcomes differ by race to understand the impact of menthol policies on Black (vs. non-Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate changes in the number of cigarettes smoked per day during the 8-week study period and will examine differences by regulatory scenario. Secondary outcomes will compare percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black participants to compare the magnitude of the effect of the various menthol policy scenarios by race. Results will contribute critical information regarding menthol in cigarettes and e-cigarettes to inform regulatory policies that maximize reductions in cigarette smoking and reduce tobacco-related health disparities. NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.