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

NCT04861428 | Terminated

• 1 other identifier: HCC 20-245
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Behaviors

Keywords

HnB: heat not burn tobacco product; IQOS: commercially available HnB manufactured

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cigarette craving

  Up to 5 weeks

• Withdrawal symptoms

  Up to 5 weeks

Other Outcomes (1)

• Complete switching

  Up to 2 weeks

Study Arms (2)

IQOS / Smoking as usual

EXPERIMENTAL

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

Other: IQOS; Other: Smoking as Usual

Smoking as usual / IQOS

ACTIVE COMPARATOR

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

Other: IQOS; Other: Smoking as Usual

Interventions

IQOS OTHER

IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).

IQOS / Smoking as usual; Smoking as usual / IQOS

Smoking as Usual OTHER

Cigarette smoking

IQOS / Smoking as usual; Smoking as usual / IQOS

Eligibility Criteria

• Age: 21 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 27, 2021
• Study Start: June 23, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)