Clinical trial · Interventional
Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cigarette Smoking-Related Carcinoma | Cigarette Smoking-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Menthol Cigarette Smoking | Behavioral | — | UNRESOLVED |
| Nasal Epithelial Lining Fluid | Diagnostic Test | — | UNRESOLVED |
| Non-menthol Cigarette Smoking | Behavioral | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Spirometry | Diagnostic Test | — | UNRESOLVED |
| Synthetic Cooling Agent Cigarette Smoking | Behavioral | — | UNRESOLVED |
| Usual Brand Cigarette Smoking | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Menthol cigarette
- description
- 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.
- interventionNames
- Behavioral: Menthol Cigarette Smoking
- Behavioral: Usual Brand Cigarette Smoking
- Diagnostic Test: Spirometry
- Other: Questionnaire Administration
- Diagnostic Test: Nasal Epithelial Lining Fluid
- type
- ACTIVE_COMPARATOR
- label
- Non-menthol cigarette
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 29 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNiu Z, Miller L, Keke CM, Rings V, Hinton A, Nshimiyimana JD, Brinkman MC, El-Hellani A, Wagener TL, Tackett AP. Appeal, sensory characteristics and puffing topography of 'cool non-menthol' cigarettes among young adults who smoke: a randomised cross-over pilot trial. Tob Control. 2026 Jul 24:tc-2026-060118. doi: 10.1136/tc-2026-060118. Online ahead of print. PMID 42498634