CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled / 34 target
Drug / intervention
Non-menthol Cigarette Smoking +6 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06230159
NCT06230159N/ACompletedOn Track (1.1/mo)Completion was 24mo ago
CompareCT.gov

Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study

Ohio State University Comprehensive Cancer Center·interventional·Posted Jan 30, 2024·Updated Jun 3, 2026

In Brief

A clinical study evaluating Non-menthol Cigarette Smoking, Menthol Cigarette Smoking, and 5 other interventions for Cigarette Smoking-Related Carcinoma. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCigarette Smoking-Related Carcinoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJan 30, 2024
Enrollment StartNov 28, 2023
Primary CompletionJun 12, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.4 years ago

Arms & Interventions

Menthol cigaretteactive_comparator

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.

Behavioral: Menthol Cigarette SmokingBehavioral: Usual Brand Cigarette SmokingDiagnostic Test: SpirometryOther: Questionnaire AdministrationDiagnostic Test: Nasal Epithelial Lining Fluid
Non-menthol cigaretteactive_comparator

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.

Behavioral: Non-menthol Cigarette SmokingBehavioral: Usual Brand Cigarette SmokingDiagnostic Test: SpirometryOther: Questionnaire AdministrationDiagnostic Test: Nasal Epithelial Lining Fluid
Cigarette with synthetic cooling agentsactive_comparator

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.

Behavioral: Synthetic Cooling Agent Cigarette SmokingBehavioral: Usual Brand Cigarette SmokingDiagnostic Test: SpirometryOther: Questionnaire AdministrationDiagnostic Test: Nasal Epithelial Lining Fluid

Interventions

Non-menthol Cigarette Smokingbehavioral

Smoke a non-menthol cigarette

Menthol Cigarette Smokingbehavioral

Smoke a menthol cigarette

Synthetic Cooling Agent Cigarette Smokingbehavioral

Smoke a synthetic cooling agent cigarette

Usual Brand Cigarette Smokingbehavioral

Smoke usual brand cigarette

Spirometryother

Pulmonary function test

Questionnaire Administrationother

Survey questionnaires

Nasal Epithelial Lining Fluidother

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