Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)
Study Details
Study Description
Brief Summary
A novel heat-not-burn tobacco product (IQOS) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The current within-subjects crossover study aims to directly compare initial efficacy of IQOS vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers.
Study interventions include IQOS, a commercially available, over the counter product. The IQOS is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade.
All procedures will take place in the Prevention and Early Detection Center (PEDC) at the UPMC Hillman Cancer Center. Participants will be assessed daily via remote CO assessment and online questionnaire throughout the entire study (WK1-WK5). At the end of a one-week baseline of normal smoking (WK1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive IQOS use (IQOS First); or 2) continue to smoke as usual (IQOS Last; WK2-WK3), followed by a second two-week period during which they will smoke as usual or attempt to switch to IQOS (opposite of the first period; WK4-WK5).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IQOS / Smoking as usual Two weeks of IQOS, followed by two weeks of cigarette smoking as usual. |
Other: IQOS
IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
Other: Smoking as Usual
Cigarette smoking
|
| Active Comparator: Smoking as usual / IQOS Two weeks of cigarette smoking as usual, followed by two weeks of IQOS. |
Other: IQOS
IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
Other: Smoking as Usual
Cigarette smoking
|
Outcome Measures
Primary Outcome Measures
- Objective smoke exposure [Up to 5 weeks]
Assessed daily using a mobile carbon monoxide monitor (iCO) provided to participants. Carbon monoxide (CO) readings parts per million (ppm) will be submitted directly via email using the iCO smartphone app.
- Self-reported smoke exposure [Up to 5 weeks]
Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.
- Harm exposure - Lung function [Up to 5 weeks]
Lung function will be assessed using standard pulmonary function test.
- Harm exposure - Blood pressure [Up to 5 weeks]
Blood pressure will be assessed using a sphygmomanometer.
Secondary Outcome Measures
- Cigarette craving [Up to 5 weeks]
Cigarette craving measured daily via Qualtrics using the Questionnaire of Smoking Urges Brief version. This will be measured on a 0-100 visual analog scale. Higher scored indicate greater craving.
- Withdrawal symptoms [Up to 5 weeks]
Withdrawal symptoms measured daily via Qualtrics using the Minnesota Nicotine Withdrawal Scale. This will be measured on a 0-18 scale. Higher scores indicate greater withdrawal symptoms.
Other Outcome Measures
- Complete switching [Up to 2 weeks]
Determined by the proportion of days where combination of CO values <7 ppm and zero self-reported cigarettes per day during the IQOS period.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, ages 21-77
-
Current smoker with ≥5 cigarettes per day for ≥1 year history of smoking
-
Screening CO ≥8 ppm
-
Not currently interested in quitting smoking
-
Willing to briefly switch from combustible to noncombustible nicotine
-
Have reliable daily access to a smartphone or tablet compatible with the iCO
Smokerlyzer app:
-
Android 8 or higher, iOS 8 or higher
-
Bluetooth-enabled device
Exclusion Criteria:
-
Current use of smoking cessation medications such as varenicline or bupropion
-
Major chronic medical problems, including cardiovascular disease, diabetes
-
Pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
Sponsors and Collaborators
- University of Pittsburgh
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCC 20-245