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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230159
• Other study ID #: OSU-23208
• Secondary ID: NCI-2023-10761
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Non-menthol Cigarette Smoking
Smoke a non-menthol cigarette
• Menthol Cigarette Smoking
Smoke a menthol cigarette
• Synthetic Cooling Agent Cigarette Smoking
Smoke a synthetic cooling agent cigarette
• 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.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Chemical Contents	Tobacco samples from all three study cigarette types (menthol, non-menthol, synthetic cooling agent) will be extracted with isopropanol containing carvacrol. Nicotine, menthol, WS-3, WS-5, WS-12, and WS-23 amounts (mass) present in the different cigarettes will be quantified using gas chromatography mass spectrometry.	Up to end of study, estimated 1 year
Primary	Impact of Cooling Effects on Demand via the Forced Choice Task	At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes.	Up to end of study intervention, up to 3 weeks
Primary	Abuse Liability via Puff Topography	Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.	Up to end of study intervention, up to 3 weeks
Primary	Cigarette Appeal	Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely).	Up to end of study intervention, up to 3 weeks

External Links

•   The Jamesline