Trial Outcomes & Findings for The Effects of IQOS Use on Cigarette Smoking Behaviors (NCT NCT05076708)
NCT ID: NCT05076708
Last Updated: 2025-02-03
Results Overview
The primary outcome was the count of cigarettes per day (CPD) across the 14-day switch period (days 8-21) compared with the average CPD at baseline (days 1-5). This outcome was determined by counting each daily spent cigarette filter returned and self-reported CPD. The correlation between self-report and spent filter return was r=0.98. For the analysis, the daily counts were transformed to a percentage of the participant's average smoking rate from the baseline ad-lib smoking period.
COMPLETED
EARLY_PHASE1
102 participants
Day 1-Day 21 (21 days)
2025-02-03
Participant Flow
Participant milestones
| Measure |
IQOS
IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
IQOS
IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to study during switch phase
|
8
|
Baseline Characteristics
The Effects of IQOS Use on Cigarette Smoking Behaviors
Baseline characteristics by cohort
| Measure |
IQOS
n=90 Participants
IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase.
|
|---|---|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
53 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
51.20 years
STANDARD_DEVIATION 9.37 • n=99 Participants
|
|
Baseline Smoking Rate
|
13.40 cigarettes per day
STANDARD_DEVIATION 6.06 • n=99 Participants
|
|
Nicotine Dependence
|
5.11 units on a scale
STANDARD_DEVIATION 1.91 • n=99 Participants
|
|
Subjective Reward
|
8.01 units on a scale
STANDARD_DEVIATION 3.16 • n=99 Participants
|
|
Relative Reinforcing Value
Breakpoint
|
7.69 trials
STANDARD_DEVIATION 3.21 • n=99 Participants
|
|
Relative Reinforcing Value
Lower<5
|
1.88 trials
STANDARD_DEVIATION 1.58 • n=99 Participants
|
|
Relative Reinforcing Value
Higher>5
|
9.04 trials
STANDARD_DEVIATION 1.53 • n=99 Participants
|
|
Withdrawal Symptom Relief
|
-1.73 units on a scale
STANDARD_DEVIATION 3.74 • n=99 Participants
|
|
Craving Relief
|
-4.10 units on a scale
STANDARD_DEVIATION 6.11 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1-Day 21 (21 days)The primary outcome was the count of cigarettes per day (CPD) across the 14-day switch period (days 8-21) compared with the average CPD at baseline (days 1-5). This outcome was determined by counting each daily spent cigarette filter returned and self-reported CPD. The correlation between self-report and spent filter return was r=0.98. For the analysis, the daily counts were transformed to a percentage of the participant's average smoking rate from the baseline ad-lib smoking period.
Outcome measures
| Measure |
IQOS
n=90 Participants
IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase.
|
|---|---|
|
Cigarette Consumption
|
31.68 percentage of baseline smoking rate
Interval 7.82 to 55.54
|
SECONDARY outcome
Timeframe: Day 1-Day 21 (21 days)Population: The 90-participant sample was reduced to 87, with 3 subjects missing the contemplation ladder measure at the end of the study.
Motivation to quit smoking was measured at baseline (day 1) and study end (day 21) using the contemplation ladder (0 = no thoughts of quitting to 10 = taking action to quit). A summary change score was generated by subtracting the baseline measure from the measure at study end.
Outcome measures
| Measure |
IQOS
n=87 Participants
IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase.
|
|---|---|
|
Change in Motivation to Quit Smoking
|
1.47 ladder steps
Standard Deviation 1.98
|
Adverse Events
IQOS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
Perelman School of Medicine, University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place