Trial Outcomes & Findings for Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use (NCT NCT06230159)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Approximately 3 months prior to start of participant recruitment

Results posted on

2026-06-03

Participant Flow

2 participants were enrolled in the study but withdrew prior to randomization.

Participant milestones

Participant milestones
Measure	Synthetic Cooling - Non-Menthol - Menthol Participants smoke a cigarette with synthetic cooling agents on visit 1, a non-menthol cigarette on visit 2, and a menthol cigarette on visit 3	Synthetic Cooling - Menthol - Non-Menthol Participants smoke a cigarette with synthetic cooling agents on visit 1, a menthol cigarette on visit 2, and a non-menthol cigarette on visit 3	Non-Menthol - Synthetic Cooling - Menthol Participants smoke a non-menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a menthol cigarette on visit 3	Non-Menthol - Menthol - Synthetic Cooling Participants smoke a non-menthol cigarette on visit 1, a menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3	Menthol - Synthetic Cooling - Non-Menthol Participants smoke a menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a non-menthol cigarette on visit 3	Menthol - Non-Menthol - Synthetic Cooling Participants smoke a menthol cigarette on visit 1, a non-menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3
Visit 1 STARTED	5	5	5	6	5	6
Visit 1 COMPLETED	5	5	5	6	5	6
Visit 1 NOT COMPLETED	0	0	0	0	0	0
Visit 2 STARTED	5	5	5	6	5	6
Visit 2 COMPLETED	5	5	5	6	5	5
Visit 2 NOT COMPLETED	0	0	0	0	0	1
Visit 3 STARTED	5	5	5	6	5	5
Visit 3 COMPLETED	5	5	5	6	5	5
Visit 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Synthetic Cooling - Non-Menthol - Menthol Participants smoke a cigarette with synthetic cooling agents on visit 1, a non-menthol cigarette on visit 2, and a menthol cigarette on visit 3	Synthetic Cooling - Menthol - Non-Menthol Participants smoke a cigarette with synthetic cooling agents on visit 1, a menthol cigarette on visit 2, and a non-menthol cigarette on visit 3	Non-Menthol - Synthetic Cooling - Menthol Participants smoke a non-menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a menthol cigarette on visit 3	Non-Menthol - Menthol - Synthetic Cooling Participants smoke a non-menthol cigarette on visit 1, a menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3	Menthol - Synthetic Cooling - Non-Menthol Participants smoke a menthol cigarette on visit 1, a cigarette with synthetic cooling agents on visit 2, and a non-menthol cigarette on visit 3	Menthol - Non-Menthol - Synthetic Cooling Participants smoke a menthol cigarette on visit 1, a non-menthol cigarette on visit 2, and a cigarette with synthetic cooling agents on visit 3
Visit 2 Withdrawal by Subject	0	0	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Population n=32 Participants Full population of participants assessed at baseline.
Age, Continuous	25.5 years STANDARD_DEVIATION 2.2 • n=20 Participants
Sex: Female, Male Female	13 Participants n=20 Participants
Sex: Female, Male Male	19 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	5 Participants n=20 Participants
Race (NIH/OMB) White	22 Participants n=20 Participants
Race (NIH/OMB) More than one race	2 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=20 Participants
Cigarettes Smoked per Day	18.3 cigarettes STANDARD_DEVIATION 27.5 • n=20 Participants

PRIMARY outcome

Timeframe: Approximately 3 months prior to start of participant recruitment

Population: Only the study products were analysed for this aim, no participant data was included

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).

Outcome measures

Outcome measures
Measure	Menthol Cigarette n=3 Cigarette rod Menthol cigarette	Non-menthol Cigarette n=3 Cigarette rod Non-menthol cigarette	Cigarette With Synthetic Cooling Agents n=3 Cigarette rod Cigarette with synthetic cooling agents
Cigarette Chemical Contents Nicotine	22.86 mg/g of tobacco rod Standard Deviation 1.16	22.30 mg/g of tobacco rod Standard Deviation 1.31	21.42 mg/g of tobacco rod Standard Deviation 0.44
Cigarette Chemical Contents WS-3	0 mg/g of tobacco rod Standard Deviation 0	0 mg/g of tobacco rod Standard Deviation 0	3.17 mg/g of tobacco rod Standard Deviation 0.21
Cigarette Chemical Contents WS-23	0 mg/g of tobacco rod Standard Deviation 0	0 mg/g of tobacco rod Standard Deviation 0	0 mg/g of tobacco rod Standard Deviation 0
Cigarette Chemical Contents Menthol	1.64 mg/g of tobacco rod Standard Deviation 0.10	0 mg/g of tobacco rod Standard Deviation 0	0 mg/g of tobacco rod Standard Deviation 0

PRIMARY outcome

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

Population: 1 Participant excluded for non-compliance during their study visits (all 3 study products). 1 Participant excluded as records were unclear as to what product was used during their single study visit. 1 Participant excluded for their synthetic cooling agent study visit as their forced choice task was not recorded.

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.