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Completed

NCT Number: NCT06230159

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-menthol Cigarette Smoking

Behavioral

Smoke a non-menthol cigarette

Menthol Cigarette Smoking

Behavioral

Smoke a menthol cigarette

Synthetic Cooling Agent Cigarette Smoking

Behavioral

Smoke a synthetic cooling agent cigarette

Usual Brand Cigarette Smoking

Behavioral

Smoke usual brand cigarette

Spirometry

Diagnostic Test

Pulmonary function test

Questionnaire Administration

Other

Survey questionnaires

Nasal Epithelial Lining Fluid

Diagnostic Test

Nasal strip inserted into the nare to collect nasal epithelial lining fluid.

Primary outcomes

  1. Cigarette Chemical Contents

    Time frame: Approximately 3 months prior to start of participant recruitment

    Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS).

  2. Impact of Cooling Effects on Demand Via the Forced Choice Task

    Time frame: After completion of study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  3. Abuse Liability Via Puff Topography - Total Smoking Time

    Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  4. Abuse Liability Via Puff Topography - Average Puff Duration

    Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  5. Abuse Liability Via Puff Topography - Average Flow Rate

    Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  6. Abuse Liability Via Puff Topography - Average Inter-Puff Interval

    Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  7. Abuse Liability Via Puff Topography - Average Puff Volume

    Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)

    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.

  8. Cigarette Appeal

    Time frame: Post study cigarette smoking session (Week1, Week 2, Week 3)

    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). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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