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This within-subjects study aims to evaluate the effects of IQOS use on combustible cigarette smoking behaviors among 100 cigarette smokers who completed the study. After measuring baseline cigarette smoking rate, participants will receive an IQOS device and be instructed to use it (versus cigarettes) over a 14-day period. The investigators will also examine which objective and subjective effects of IQOS use predict a complete and incomplete switch from cigarettes to IQOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQOS | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQOS | Other | All participants switch from cigarette smoking to IQOS use for a 14-day phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Consumption | 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. | Day 1-Day 21 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motivation to Quit Smoking | 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. | Day 1-Day 21 (21 days) |
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Inclusion Criteria:
Exclusion Criteria:
Smoking Behavior
Alcohol and Drug
Medical
Psychiatric
General Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38871445 | Derived | Audrain-McGovern J, Wileyto EP, Klapec O, Koita F, Strasser AA. Switching from cigarettes to IQOS: the relative importance of IQOS-associated reward, reinforcement and abstinence relief. Tob Control. 2025 Oct 3;34(5):651-658. doi: 10.1136/tc-2024-058635. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IQOS | IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IQOS | IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Consumption | 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. | Posted | Mean | 95% Confidence Interval | percentage of baseline smoking rate | Day 1-Day 21 (21 days) |
|
1 month
Adverse Events were defined as any unexpected event related to IQOS use.
Serious Adverse Events were defined as any severe or serious event related to IQOS use.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IQOS | IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry | Perelman School of Medicine, University of Pennsylvania | (215) 746-7145 | audrain@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2021 | Jul 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2023 | Jul 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline Smoking Rate | Participants eligible at the intake screening completed baseline measures and received instructions to smoke as usual for the next 5 days while collecting all spent filters each day (days 1-5). The average daily spent filters served as the baseline smoking rate. | Mean | Standard Deviation | cigarettes per day |
|
| Nicotine Dependence | Nicotine dependence was measured using The Fagerstrom Test for Nicotine Dependence (FTND). The FTND is a 6-item scale with higher scores indicating greater levels of nicotine dependence. Nicotine dependence scores can range from 0 (low) to 8 (high). | Mean | Standard Deviation | units on a scale |
|
| Subjective Reward | The subjective rewarding value of IQOS was measured by averaging the two-item satisfaction subscale ('Was it satisfying'? and 'Did it taste good'?) from the Cigarette Evaluation Scale (CES) adapted for IQOS use. The CES is an 11 item Likert-format (1=not at all to 7=extremely) self-report instrument. The minimum possible score is 2 and the maximum is 14. Higher scores denote greater subjective rewarding value. | Mean | Standard Deviation | units on a scale |
|
| Relative Reinforcing Value | Using a validated computer choice task, participants chose between clicking one image to earn points for IQOS puffs (25 clicks to earn a point for a puff) or another image to earn points for cigarette puffs (25x clicks to earn a point for a puff) across 10 trials. The breakpoint, the highest trial (range 0-10) completed to earn cigarette puffs indicates the reinforcing value of cigarettes relative to IQOS. Working for cigarette puffs on <5 trials equate to a lower reinforcing value of cigarettes, whereas working on 5 or more trials reflects higher reinforcing value of cigarettes. | Mean | Standard Deviation | trials |
|
| Withdrawal Symptom Relief | Participants completed 10-hours of abstinence before trying IQOS. Withdrawal symptoms were measured by summating the 8-item Minnesota Nicotine Withdrawal Scale (MNWS). MNWS Likert response options are 0=none to 4=severe; score range=0-32). Higher scores indicate greater withdrawal symptoms. Withdrawal relief scores were calculated as post-IQOS use minus pre-IQOS use scores. The relief score represents the level of withdrawal symptom relief after IQOS use. | Mean | Standard Deviation | units on a scale |
|
| Craving Relief | Participants completed 10 hours of abstinence before trying IQOS. Craving was measured with the well-validated and reliable 4-item Negative reinforcement subscale of the brief Questionnaire of Smoking Urges (QSU-brief). Likert response options ranged from 1=strongly disagree to 7=strongly agree. Scores were calculated by summating the 4 items (range=4-28). Higher scores indicate greater cigarette cravings. A craving relief score was calculated as post-IQOS use score minus pre-IQOS use score. | Mean | Standard Deviation | units on a scale |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Change in Motivation to Quit Smoking | 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. | The 90-participant sample was reduced to 87, with 3 subjects missing the contemplation ladder measure at the end of the study. | Posted | Mean | Standard Deviation | ladder steps | Day 1-Day 21 (21 days) |
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| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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