Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)
- Conditions
- Smoking Behaviors
- Interventions
- Other: IQOSOther: Smoking as Usual
- Registration Number
- NCT04861428
- Lead Sponsor
- University of Pittsburgh
- 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.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
-
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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IQOS / Smoking as usual Smoking as Usual Two weeks of IQOS, followed by two weeks of cigarette smoking as usual. Smoking as usual / IQOS Smoking as Usual Two weeks of cigarette smoking as usual, followed by two weeks of IQOS. IQOS / Smoking as usual IQOS Two weeks of IQOS, followed by two weeks of cigarette smoking as usual. Smoking as usual / IQOS IQOS Two weeks of cigarette smoking as usual, followed by two weeks of IQOS.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States