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

Last updated: November 5, 2024
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Synthetic Cooling Agent Cigarette Smoking

Usual Brand Cigarette Smoking

Non-menthol Cigarette Smoking

Clinical Study ID

NCT06230159
OSU-23208
NCI-2023-10761
  • Ages 21-29
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 21 - 29 years

  • Established cigarette user

  • Willing to provide informed consent and abstain from using tobacco products 12 hoursprior to the three lab sessions

  • Read and speak English

Exclusion

Exclusion Criteria:

  • Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19hospitalization

  • 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

Study Design

Total Participants: 34
Treatment Group(s): 7
Primary Treatment: Synthetic Cooling Agent Cigarette Smoking
Phase:
Study Start date:
November 28, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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