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

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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Alayna P Tackett, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-28

Primary Completion

2024-06-12

Completion

2024-06-12

Countries

• United States

Study Locations