An interventional study of IQOS in Smoking and Tobacco Use, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 10 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion Criteria:
Behavioral: IQOS
Participants will try an IQOS product and then take home the IQOS to sample for one week.
Also known as: heated tobacco product (HTP)
Number of Participants Who Prefer IQOS
Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette
Time frame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
Cigarettes Per Day
The average percent reduction in cigarettes per day observed in Week 2
Time frame: Week 2 of study
| Milestone | IQOS Group |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette
| Participants | IQOS Group |
|---|---|
| Number of Participants Who Prefer IQOS | 7 |
The average percent reduction in cigarettes per day observed in Week 2
| Percentage reduction in cigs per day | IQOS Group |
|---|---|
| Cigarettes Per Day | 16.1 ± 32.7 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IQOS Group | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | IQOS Group |
|---|---|
| CoughGeneral disorders | 1/10 |
| HeadacheGeneral disorders | 1/10 |
| NauseaGeneral disorders | 1/10 |
| ER visit for medication refillGeneral disorders | 1/10 |
| Age, Continuous(years) | IQOS Group |
|---|---|
| Mean | 37.6 ± 11.0 |
| Sex: Female, Male(Participants) | IQOS Group |
|---|---|
| Female | 2 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | IQOS Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 7 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | IQOS Group |
|---|---|
| United States | 10 |
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Plan to share: No
Ran from Jul 2020 to primary completion in Oct 2020, 2 months.
Results were first posted in Oct 2021, 1 year after primary completion.
Of 141 non-industry interventional studies with no phase under Smoking, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 2 months is below that.
Counting every sponsor, half of 155 studies reached it within 37 months; a quarter within 18 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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