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

University of Pittsburgh

Status: Terminated

Conditions: Smoking Behaviors

Treatments: Other: IQOS; Other: Smoking as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04861428

HCC 20-245

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 21 to 77 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

IQOS / Smoking as usual

Experimental group

Description:

Two weeks of IQOS, followed by two weeks of cigarette smoking as usual.

Treatment:

Other: Smoking as Usual

Other: IQOS

Smoking as usual / IQOS

Active Comparator group

Description:

Two weeks of cigarette smoking as usual, followed by two weeks of IQOS.

Treatment:

Other: Smoking as Usual

Other: IQOS