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

Not Applicable

Active, not recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Behavioral: Menthol Cigarette Smoking; Behavioral: Non-menthol Cigarette Smoking; Behavioral: Synthetic Cooling Agent Cigarette Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid

• Registration Number: NCT06230159
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2023-11-28
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-30
• Primary Completion: 2024-06-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Aged 21 - 29 years
• Established cigarette user
• Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
• Read and speak English

Exclusion Criteria

• Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19 hospitalization
• Self-reported unstable or significant psychiatric conditions
• History of cardiac event or distress within the past 3 months
• Are currently pregnant, planning to become pregnant, or breastfeeding
• Currently attempting to quit using combustible tobacco products
• Have suffered from any serious lung disease or infection in the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Menthol cigarette	Questionnaire Administration	Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Menthol cigarette	Menthol Cigarette Smoking	Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Menthol cigarette	Usual Brand Cigarette Smoking	Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Non-menthol cigarette	Questionnaire Administration	Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Cigarette with synthetic cooling agents	Spirometry	Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.
Menthol cigarette	Spirometry	Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Non-menthol cigarette	Usual Brand Cigarette Smoking	Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Non-menthol cigarette	Nasal Epithelial Lining Fluid	Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Menthol cigarette	Nasal Epithelial Lining Fluid	Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit.
Cigarette with synthetic cooling agents	Nasal Epithelial Lining Fluid	Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.
Non-menthol cigarette	Non-menthol Cigarette Smoking	Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Non-menthol cigarette	Spirometry	Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit.
Cigarette with synthetic cooling agents	Synthetic Cooling Agent Cigarette Smoking	Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.
Cigarette with synthetic cooling agents	Usual Brand Cigarette Smoking	Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.
Cigarette with synthetic cooling agents	Questionnaire Administration	Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit.

Primary Outcome Measures

Name	Time	Method
Impact of Cooling Effects on Demand via the Forced Choice Task	Up to end of study intervention, up to 3 weeks	At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes.
Cigarette Appeal	Up to end of study intervention, up to 3 weeks	Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely).
Cigarette Chemical Contents	Up to end of study, estimated 1 year	Tobacco samples from all three study cigarette types (menthol, non-menthol, synthetic cooling agent) will be extracted with isopropanol containing carvacrol. Nicotine, menthol, WS-3, WS-5, WS-12, and WS-23 amounts (mass) present in the different cigarettes will be quantified using gas chromatography mass spectrometry.
Abuse Liability via Puff Topography	Up to end of study intervention, up to 3 weeks	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States