Cigarette Smoking-Related Carcinoma
Conditions
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. 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.
Interventions
BEHAVIORALNon-menthol Cigarette Smoking
Smoke a non-menthol cigarette
BEHAVIORALMenthol Cigarette Smoking
Smoke a menthol cigarette
BEHAVIORALSynthetic Cooling Agent Cigarette Smoking
Smoke a synthetic cooling agent cigarette
BEHAVIORALUsual Brand Cigarette Smoking
Smoke usual brand cigarette
DIAGNOSTIC_TESTSpirometry
Pulmonary function test
OTHERQuestionnaire Administration
Survey questionnaires
DIAGNOSTIC_TESTNasal Epithelial Lining Fluid
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and data collection staff will be blinded to the order/conditions
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 29 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Chemical Contents | Approximately 3 months prior to start of participant recruitment | 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). |
| Impact of Cooling Effects on Demand Via the Forced Choice Task | After completion of study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Abuse Liability Via Puff Topography - Total Smoking Time | During study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Abuse Liability Via Puff Topography - Average Puff Duration | During study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Abuse Liability Via Puff Topography - Average Flow Rate | During study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Abuse Liability Via Puff Topography - Average Inter-Puff Interval | During study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Abuse Liability Via Puff Topography - Average Puff Volume | During study cigarette smoking session (Week 1, Week 2, Week 3) | 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. |
| Cigarette Appeal | Post study cigarette smoking session (Week1, Week 2, Week 3) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlayna P Tackett, PhD
Ohio State University Comprehensive Cancer Center
Participant flow
Pre-assignment details
2 participants were enrolled in the study but withdrew prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 25.5 years STANDARD_DEVIATION 2.2 |
| Cigarettes Smoked per Day | 18.3 cigarettes STANDARD_DEVIATION 27.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 32 | 0 / 31 | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 | 0 / 31 | 0 / 29 |
Outcome results
None listed