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

NCT06230159 | Completed Results DMC

• 2 other identifiers: OSU-23208NCI-2023-10761
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Cigarette Chemical Contents

  Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS).

  Approximately 3 months prior to start of participant recruitment

• 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.

  After completion of study cigarette smoking session (Week 1, Week 2, Week 3)

• Abuse Liability Via Puff Topography - Total Smoking Time

  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.

  During study cigarette smoking session (Week 1, Week 2, Week 3)

• Abuse Liability Via Puff Topography - Average Puff Duration

  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.

  During study cigarette smoking session (Week 1, Week 2, Week 3)

• Abuse Liability Via Puff Topography - Average Flow Rate

  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.

  During study cigarette smoking session (Week 1, Week 2, Week 3)

• Abuse Liability Via Puff Topography - Average Inter-Puff Interval

  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.

  During study cigarette smoking session (Week 1, Week 2, Week 3)

• Abuse Liability Via Puff Topography - Average Puff Volume

  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.

  During study cigarette smoking session (Week 1, Week 2, Week 3)

• 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). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.

  Post study cigarette smoking session (Week1, Week 2, Week 3)

Study Arms (3)

Menthol cigarette

ACTIVE 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 Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid

Non-menthol cigarette

ACTIVE 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 Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid

Cigarette with synthetic cooling agents

ACTIVE 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 Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid

Interventions

Non-menthol Cigarette Smoking BEHAVIORAL

Smoke a non-menthol cigarette

Non-menthol cigarette

Menthol Cigarette Smoking BEHAVIORAL

Smoke a menthol cigarette

Menthol cigarette

Synthetic Cooling Agent Cigarette Smoking BEHAVIORAL

Smoke a synthetic cooling agent cigarette

Cigarette with synthetic cooling agents

Usual Brand Cigarette Smoking BEHAVIORAL

Smoke usual brand cigarette

Cigarette with synthetic cooling agents; Menthol cigarette; Non-menthol cigarette

Spirometry DIAGNOSTIC_TEST

Pulmonary function test

Cigarette with synthetic cooling agents; Menthol cigarette; Non-menthol cigarette

Questionnaire Administration OTHER

Survey questionnaires

Cigarette with synthetic cooling agents; Menthol cigarette; Non-menthol cigarette

Nasal Epithelial Lining Fluid DIAGNOSTIC_TEST

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

Cigarette with synthetic cooling agents; Menthol cigarette; Non-menthol cigarette

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Spirometry

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Alayna Tackett
• Organization: Ohio State University Comprehensive Cancer Center

alayna.tackett@osumc.edu

844-744-2447

Study Officials

• Alayna P Tackett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and data collection staff will be blinded to the order/conditions
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Using a cross-over double-blinded study design, we will study the abuse liability (including sensory characteristics and appeal) of newly introduced cooling agent non-menthol cigarettes.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 30, 2024
• Study Start: November 28, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: June 3, 2026
• Results First Posted: June 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)