Addiction potential of combustible menthol cigarette alternatives: a randomised cross-over trial

Abstract

IntroductionThe Food and Drug Administration (FDA) has issued proposed product standards banning menthol as a characterising flavour in cigarettes and cigars. The public health benefits of these product standards may be attenuated by the role of plausible substitutes in the marketplace. Therefore, the present study examined the addiction potential of plausible combustible menthol alternatives compared with usual brand menthol cigarettes (UBMC).MethodsNinety-eight adult menthol cigarette smokers completed four visits, smoking their UBMC at the first session and three menthol cigarette alternatives in random order at the subsequent visits: (1) a preassembled menthol roll-your-own (mRYO) cigarette using menthol pipe tobacco and mentholated cigarette tube, (2) a menthol filtered little cigar (mFLC) and (3) a non-menthol cigarette (NMC). Measures of smoking topography, exhaled carbon monoxide (CO), craving and withdrawal, subjective effects and behavioural economic demand indices were assessed.ResultsCompared with UBMC, menthol cigarette alternatives resulted in different puffing topography and CO exposure (except mRYO), and lower levels of positive subjective experience and behavioural economic demand indices. Among the alternative products, participants reported the highest level of positive subjective experience and higher demand for mRYO, compared with mFLC and NMC. Similarly, participants were significantly more likely to want to try again, purchase and use the mRYO product regularly compared with mFLC and NMC.Conclusions and relevancemRYO cigarettes were the most highly rated cigarette alternative among study products, suggesting their potential appeal as a menthol cigarette substitute and needed inclusion of menthol pipe tobacco and cigarette tubes in FDA’s proposed ban.

Substitutability of menthol cigarette alternatives: a clinical trial

“…However, even after a week-long trial with one's chosen alternative product, UBMCs remained preferred in a concurrent choice self-administration experiment. Consistent with our prior work, 25 this study supports including menthol pipe tobacco and tubes (roll-your-own) in flavoured tobacco bans. Future studies examining potential MCAs should address menthol-flavoured non-combusted nicotine products and cigarette products containing synthetic cooling agents that have emerged in response to flavoured tobacco policies.…”

“…This is especially surprising since mFLC also demonstrated lower nicotine delivery than mRYO and NMC. 25 In addition, while still reporting higher levels of positive subjective experience than the other MCA, mRYO participants reported waning product appeal over the product trial week, with decreases in most measures of subjective effects; this was a similar pattern across all MCAs, although small cell sizes for mFLC and NMC limited inferences about significant change in these measures. Waning appeal was also evident in mRYO having the highest median breakpoint compared with NMC and mFLC in a concurrent choice selfadministration task that occurred following the product trial week.…”

“…This phase used multiple methods of assessing addiction potential in a lab-based setting, including an acute dose-effect comparison study, drug self-administration, suppression of craving and withdrawal, behavioural economics, and forced choice of their preferred MCA; phase 1 results have been published elsewhere, including lab characterisations of each of the MCA products. 25 During phase 2, participants were provided their most preferred MCA at no cost in standardised packaging (online supplemental figure S1) and instructed to completely switch and exclusively use the MCA during the 1-week trial period. During this period, participants completed evening daily diaries via EMA.…”

“…Our prior publication in 98 adults who smoked menthol cigarettes and completed a four-session randomised crossover lab study found that each of these menthol cigarette alternatives (MCAs; ie, mFLC, mRYO and NMC) significantly reduced nicotine craving and withdrawal symptoms, but the combination of mentholated pipe tobacco and tubes in an mRYO resulted in the highest behavioural economic demand and positive subjective experience. 25 The goal of the current study was to assess the substitutability of these three combustible MCAs in the same sample during an extended observation phase. Consistent with an established framework for abuse liability assessment, 26 we assessed substitutability using measures of product adherence, craving and withdrawal during self-administration, changes in subjective effects, hypothetical purchase tasks, and a concurrent choice self-administration task.…”

“…All participants provided written informed consent. Findings from phase 1 are reported elsewhere, with the full study protocol provided in the online supplemental materials 25 ; in this publication the results of phase 2 and phase 3 in this publication.…”