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

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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

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

Trial contacts and locations

1

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Central trial contact

The Ohio State Comprehensive Cancer Center

Data sourced from clinicaltrials.gov

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