Smoking, Cigarette Smoking, Tobacco Use
Conditions
Brief summary
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.
Interventions
OTHERIQOS
All participants switch from cigarette smoking to IQOS use for a 14-day phase.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to communicate fluently in English (i.e. speaking, writing, and reading). 2. Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months. 3. Not currently undergoing smoking cessation treatment or planning to quit smoking within the next 30 days. 4. Report an interest in quitting smoking within the next 6 months. 5. Plan to live in the area for the duration of the study 6. Willing to use study provided IQOS devices and HeatSticks during 2 laboratory visits and throughout study participation. 7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Exclusion criteria
Smoking Behavior 1. Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes for the duration of study will be considered eligible. 2. Current enrollment or plans to enroll in a smoking cessation program over the duration of the study (i.e. 21 days/3 weeks). 3. Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug 1. History of substance abuse (other than nicotine dependence) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol. 2. Current alcohol consumption that exceeds 20 standard drinks/week. 3. Breath alcohol reading (BrAC) greater than .000 at Intake. Medical 1. Women, including all individuals assigned as female at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. 2. Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator. Psychiatric 1. Lifetime history of schizophrenia or psychosis. 2. Lifetime history or current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate. 3. Lifetime history of a suicide attempt. General Exclusion 1. Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator. 2. Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen. 3. Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/o. Subjects may be deemed ineligible at any point throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Consumption | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motivation to Quit Smoking | Day 1-Day 21 (21 days) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQOS IQOS: All participants switch from cigarette smoking to IQOS use for a 14-day phase. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to study during switch phase | 8 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | IQOS |
|---|---|
| Age, Continuous | 51.20 years STANDARD_DEVIATION 9.37 |
| Baseline Smoking Rate | 13.40 cigarettes per day STANDARD_DEVIATION 6.06 |
| Craving Relief | -4.10 units on a scale STANDARD_DEVIATION 6.11 |
| Nicotine Dependence | 5.11 units on a scale STANDARD_DEVIATION 1.91 |
| Race/Ethnicity, Customized Black/African American | 53 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White | 32 Participants |
| Relative Reinforcing Value Breakpoint | 7.69 trials STANDARD_DEVIATION 3.21 |
| Relative Reinforcing Value Higher>5 | 9.04 trials STANDARD_DEVIATION 1.53 |
| Relative Reinforcing Value Lower<5 | 1.88 trials STANDARD_DEVIATION 1.58 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 52 Participants |
| Subjective Reward | 8.01 units on a scale STANDARD_DEVIATION 3.16 |
| Withdrawal Symptom Relief | -1.73 units on a scale STANDARD_DEVIATION 3.74 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
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.
Time frame: Day 1-Day 21 (21 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IQOS | Cigarette Consumption | 31.68 percentage of baseline smoking rate |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS | Change in Motivation to Quit Smoking | 1.47 ladder steps | Standard Deviation 1.98 |