Clinical trial NCT06230159: Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
Official title: Synthetic Cooling Agents in Combustible Cigarettes: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cigarette Chemical Contents
timeFrame: Up to end of study, estimated 1 year
measure: Impact of Cooling Effects on Demand via the Forced Choice Task
timeFrame: Up to end of study intervention, up to 3 weeks
measure: Abuse Liability via Puff Topography
timeFrame: Up to end of study intervention, up to 3 weeks
measure: Cigarette Appeal
timeFrame: Up to end of study intervention, up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Alayna P Tackett, PhD
role: PRINCIPAL_INVESTIGATOR
References: