NCT06230159

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

Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 29 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Non-menthol Cigarette Smoking	Smoke a non-menthol cigarette
BEHAVIORAL	Menthol Cigarette Smoking	Smoke a menthol cigarette
BEHAVIORAL	Synthetic Cooling Agent Cigarette Smoking	Smoke a synthetic cooling agent cigarette
BEHAVIORAL	Usual Brand Cigarette Smoking	Smoke usual brand cigarette
DIAGNOSTIC_TEST	Spirometry	Pulmonary function test
OTHER	Questionnaire Administration	Survey questionnaires
DIAGNOSTIC_TEST	Nasal Epithelial Lining Fluid	Nasal strip inserted into the nare to collect nasal epithelial lining fluid.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2024-01-30
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States