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Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:
Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study

Clinical Trial Summary

This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes. II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes. EXPLORATORY OBJECTIVE: I. Examine acute changes to pulmonary health associated with cooling agent cigarette use. OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits. Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit. ;

Study Design

Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma
Clinical Trial Details
NCT number NCT06230159
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Status Recruiting
Phase N/A
Start date November 28, 2023
Completion date December 31, 2025
View Details
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