Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)

Initial Cross-over Test of a Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine in Smokers

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.

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).

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).