N/A
N=33
The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute
Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT05499377 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Percent Change in Average Daily Cigarette Use Per Day From Baseline — 36.8; 80.36 % reduction in cigarettes per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tobacco product administration and assessment (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Average Daily Cigarette Use Per Day From Baseline |
36.8; 80.36 | — |
| PRIMARY Percent Increase in Demand as the Subject is Willing to Substitute From Cigarettes to HTPs Using the Experimental Tobacco Marketplace Task |
0.14; 0.67 | — |
| PRIMARY Plasma Nicotine Delivery |
6.3; 6.6 | — |
| SECONDARY Cigarette Craving Suppression Questionnaire |
-9.5; -41.5 | — |
| SECONDARY Puff Topography (Puff Duration) |
1.64; 1.33 | — |
| SECONDARY Average Daily IQOS Usage |
4.5; 4.3 | — |
Summary
This project examines the influence of flavor availability on switching to an MRTP known as IQOS, part of the Heated Tobacco Product (HTP) class, among menthol smokers using clinical lab and naturalistic evaluations of abuse liability. Results will help federal regulators predict the public health impact on menthol cigarette smokers of policies restricting access to menthol-flavored HTPs.
Eligibility Criteria
Inclusion Criteria
- Healthy adults (aged 21 and older)
- Daily menthol cigarette smokers
- Exhaled Carbon Monoxide (CO) reading of > 5 PPM at in-person screening (to confirm smoking status)
- A 'positive' cotinine cassette result to verify nicotine use at the in-person screening.
- Participants must be willing to provide informed consent and abstain from nicotine/tobacco for ≥8 hours prior to each lab session.
- Participants must have access to a computer/smartphone and be willing to receive and respond to daily surveys
- Able to read and write in English
Exclusion Criteria
- Daily use of any tobacco products other than cigarettes
- Self-reported history of chronic medical or psychiatric conditions
- Women will be excluded if they test positive for pregnancy (by urinalysis) or self-report breastfeeding.
Some details of the study inclusion and exclusion criteria are omitted at this time, to preserve scientific integrity. Full inclusion and exclusion criteria will be posted following study completion.
Data sourced from ClinicalTrials.gov (NCT05499377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.