Clinical trial NCT04861428: Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)
Official title: Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Behaviors
Keywords: HnB: heat not burn tobacco product
IQOS: commercially available HnB manufactured
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

Eligibility 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).

Primary outcomes:
measure: Objective smoke exposure
timeFrame: Up to 5 weeks
measure: Self-reported smoke exposure
timeFrame: Up to 5 weeks
measure: Harm exposure - Lung function
timeFrame: Up to 5 weeks
measure: Harm exposure - Blood pressure
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Cigarette craving
timeFrame: Up to 5 weeks
measure: Withdrawal symptoms
timeFrame: Up to 5 weeks
Other outcomes:
measure: Complete switching
timeFrame: Up to 2 weeks
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
References: