Smoking, Tobacco Use
Conditions
Brief 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.
Interventions
BEHAVIORALIQOS
Participants will try an IQOS product and then take home the IQOS to sample for one week.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Prefer IQOS | Lab Visit 2, occurring approximately one week after the initial screening/baseline visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Per Day | Week 2 of study | The average percent reduction in cigarettes per day observed in Week 2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQOS Group IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | IQOS Group |
|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IQOS Group | Number of Participants Who Prefer IQOS | 7 Participants |
Secondary
Cigarettes Per Day
The average percent reduction in cigarettes per day observed in Week 2
Time frame: Week 2 of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQOS Group | Cigarettes Per Day | 16.1 Percentage reduction in cigs per day | Standard Deviation 32.7 |