Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Impact of Cooling Effects on Demand via the Forced Choice Task
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants and data collection staff will be blinded to the order/conditions
Eligibility Criteria
- Ages
- 21 Years to 29 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Cigarette with synthetic cooling agents
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.
Intervention: Usual Brand Cigarette Smoking (Behavioral)
Cigarette with synthetic cooling agents
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.
Intervention: Spirometry (Diagnostic Test)
Menthol cigarette
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.
Intervention: Questionnaire Administration (Other)
Menthol cigarette
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.
Intervention: Menthol Cigarette Smoking (Behavioral)
Menthol cigarette
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.
Intervention: Usual Brand Cigarette Smoking (Behavioral)
Menthol cigarette
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.
Intervention: Spirometry (Diagnostic Test)
Menthol cigarette
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.
Intervention: Nasal Epithelial Lining Fluid (Diagnostic Test)
Non-menthol cigarette
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.
Intervention: Non-menthol Cigarette Smoking (Behavioral)
Non-menthol cigarette
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.
Intervention: Usual Brand Cigarette Smoking (Behavioral)
Non-menthol cigarette
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.
Intervention: Spirometry (Diagnostic Test)
Non-menthol cigarette
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.
Intervention: Questionnaire Administration (Other)
Non-menthol cigarette
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.
Intervention: Nasal Epithelial Lining Fluid (Diagnostic Test)
Cigarette with synthetic cooling agents
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.
Intervention: Synthetic Cooling Agent Cigarette Smoking (Behavioral)
Cigarette with synthetic cooling agents
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.
Intervention: Questionnaire Administration (Other)
Cigarette with synthetic cooling agents
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.
Intervention: Nasal Epithelial Lining Fluid (Diagnostic Test)
Outcomes
Primary Outcomes
Impact of Cooling Effects on Demand via the Forced Choice Task
Time Frame: Up to end of study intervention, up to 3 weeks
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.
Cigarette Appeal
Time Frame: Up to end of study intervention, up to 3 weeks
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).
Cigarette Chemical Contents
Time Frame: Up to end of study, estimated 1 year
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.
Abuse Liability via Puff Topography
Time Frame: Up to end of study intervention, up to 3 weeks
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alayna Tackett
Principal Investigator
Ohio State University Comprehensive Cancer Center