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

The Ohio State University

Status: Enrolling

Conditions: Cigarette Smoking-Related Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06230159

NCI-2023-10761 (Registry Identifier)

OSU-23208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Menthol cigarette

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Menthol Cigarette Smoking

Diagnostic Test: Nasal Epithelial Lining Fluid

Diagnostic Test: Spirometry

Behavioral: Usual Brand Cigarette Smoking

Non-menthol cigarette

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Diagnostic Test: Nasal Epithelial Lining Fluid

Diagnostic Test: Spirometry

Behavioral: Non-menthol Cigarette Smoking

Behavioral: Usual Brand Cigarette Smoking

Cigarette with synthetic cooling agents

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Diagnostic Test: Nasal Epithelial Lining Fluid

Diagnostic Test: Spirometry

Behavioral: Synthetic Cooling Agent Cigarette Smoking

Behavioral: Usual Brand Cigarette Smoking