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

Study Overview

• Status: Terminated
• Conditions: Smoking Behaviors
• Intervention / Treatment: Other: IQOS; Other: 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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective smoke exposure	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.	Up to 5 weeks
Self-reported smoke exposure	Assessed daily using self-reported cigarette consumption, with values submitted via online Qualtrics survey.	Up to 5 weeks
Harm exposure - Lung function	Lung function will be assessed using standard pulmonary function test.	Up to 5 weeks
Harm exposure - Blood pressure	Blood pressure will be assessed using a sphygmomanometer.	Up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette craving	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.	Up to 5 weeks
Withdrawal symptoms	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.	Up to 5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete switching	Determined by the proportion of days where combination of CO values <7 ppm and zero self-reported cigarettes per day during the IQOS period.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HnB: heat not burn tobacco product; IQOS: commercially available HnB manufactured
• Other Study ID Numbers: HCC 20-245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No