Addiction Potential of Combustible Menthol Cigarette Alternatives: A Randomized Crossover Trial

Abstract

Introduction: The FDA announced its intention to issue proposed product standards banning menthol as a characterizing flavor 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 to usual brand menthol cigarettes (UBMC). Methods: Eighty adult menthol cigarette smokers completed four visits, smoking their UBMC at the first session and 3 menthol cigarette alternatives in random order at the subsequent visits: 1) a pre-assembled menthol roll-your-own cigarette using menthol pipe tobacco and mentholated cigarette tube (mRYO), 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 behavioral economic demand indices were assessed. Results: Compared to UBMC, menthol cigarette alternatives resulted in similar topography and CO exposure but significantly lower levels of positive subjective experience and behavioral 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 Relevance: mRYO 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

The trial was registered in clinicaltrials.gov (NCT04844762).

Funding Statement

Research reported in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R21DA046333 (MPI: TW and AV). JS, JT and TE were supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number U54DA036114. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the US Food and Drug Administration. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Board of the Ohio State University gave ethical approval for this work (IRB Protocol Number: 2019C0107).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

The corresponding author will make deidentified participant data and the data dictionary available following publication. Institutions and individuals wishing to access any resources or data must contact the corresponding author (theodore.wagener@osumc.edu). Data will only be made available to those whose proposed use of the data has been approved by the corresponding author. Data will be made available for the sole purpose of replicating the analyses reported in the manuscript. The recipient must agree to not transfer the data to other users and that the data are only to be used for research purposes. The PIs will require requestors of data to sign a data sharing agreement that will ensure (1) Use of the data are only for research purposes (2) Data security using appropriate technology/firewalls, (3) Destruction of data after data analysis and (4) Proper citation in publications or other written materials. A record of transfer of data and a copy of the dataset that was distributed will be kept by The Ohio State University.

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