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

Smoking Behaviors Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04861428
• Other study ID #: HCC 20-245
• Status: Terminated
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 77 Years

Eligibility

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).

Related Conditions & MeSH terms

• Smoking Behaviors

Intervention

Other:
• IQOS
IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
• Smoking as Usual
Cigarette smoking

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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