N/A
N=10
IQOS (Non-Cigarette Tobacco Product) Pilot Study
Smoking · Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT04357379 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants Who Prefer IQOS — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IQOS (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Prefer IQOS |
7 | — |
| SECONDARY Cigarettes Per Day |
16.1 | — |
Summary
A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.
Eligibility Criteria
Inclusion Criteria
- daily cigarette smoker
- interested in using non-cigarette tobacco product
- have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).
Exclusion Criteria
- additional tobacco use criteria
- additional medical criteria
Data sourced from ClinicalTrials.gov (NCT04357379). 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.