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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQOS group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQOS | Behavioral | Participants will try an IQOS product and then take home the IQOS to sample for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Lab Visit 2, occurring approximately one week after the initial screening/baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Per Day | The average percent reduction in cigarettes per day observed in Week 2 | Week 2 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IQOS Group | IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IQOS Group | IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week. |
| 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 | 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 | Posted | Count of Participants | Participants | Lab Visit 2, occurring approximately one week after the initial screening/baseline visit |
|
|
2 weeks
Interviewer-administered assessment at each visit
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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 Group | IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracy Smith | Medical University of South Carolina | 8437925164 | smithtra@musc.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 18, 2020 | Oct 25, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2020 | Jan 21, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Cigarettes Per Day | The average percent reduction in cigarettes per day observed in Week 2 | Posted | Mean | Standard Deviation | Percentage reduction in cigs per day | Week 2 of study |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| Headache | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| ER visit for medication refill | General disorders | Systematic Assessment |
|
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