The Effects of IQOS Use on Cigarette Smoking Behaviors

NCT05076708 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 843646
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This within-subjects study aims to evaluate the effects of IQOS use on combustible cigarette smoking behaviors among 100 cigarette smokers who completed the study. After measuring baseline cigarette smoking rate, participants will receive an IQOS device and be instructed to use it (versus cigarettes) over a 14-day period. The investigators will also examine which objective and subjective effects of IQOS use predict a complete and incomplete switch from cigarettes to IQOS.

Conditions

Smoking; Cigarette Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Cigarette Consumption

  The primary outcome was the count of cigarettes per day (CPD) across the 14-day switch period (days 8-21) compared with the average CPD at baseline (days 1-5). This outcome was determined by counting each daily spent cigarette filter returned and self-reported CPD. The correlation between self-report and spent filter return was r=0.98. For the analysis, the daily counts were transformed to a percentage of the participant's average smoking rate from the baseline ad-lib smoking period.

  Day 1-Day 21 (21 days)

Secondary Outcomes (1)

• Change in Motivation to Quit Smoking

  Day 1-Day 21 (21 days)

Study Arms (1)

IQOS

OTHER

Other: IQOS

Interventions

IQOS OTHER

All participants switch from cigarette smoking to IQOS use for a 14-day phase.

IQOS

Eligibility Criteria

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

You may qualify if:

• Able to communicate fluently in English (i.e. speaking, writing, and reading).
• Male and female smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months.
• Not currently undergoing smoking cessation treatment or planning to quit smoking within the next 30 days.
• Report an interest in quitting smoking within the next 6 months.
• Plan to live in the area for the duration of the study
• Willing to use study provided IQOS devices and HeatSticks during 2 laboratory visits and throughout study participation.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

You may not qualify if:

• Smoking Behavior
• Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes for the duration of study will be considered eligible.
• Current enrollment or plans to enroll in a smoking cessation program over the duration of the study (i.e. 21 days/3 weeks).
• Provide a CO breath test reading less than 10 ppm at Intake.
• Alcohol and Drug
• History of substance abuse (other than nicotine dependence) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 20 standard drinks/week.
• Breath alcohol reading (BrAC) greater than .000 at Intake.
• Medical
• Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
• Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
• Psychiatric
• Lifetime history of schizophrenia or psychosis.
• Lifetime history or current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
• Lifetime history of a suicide attempt.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Audrain-McGovern J, Wileyto EP, Klapec O, Koita F, Strasser AA. Switching from cigarettes to IQOS: the relative importance of IQOS-associated reward, reinforcement and abstinence relief. Tob Control. 2025 Oct 3;34(5):651-658. doi: 10.1136/tc-2024-058635.

  PMID: 38871445 DERIVED

MeSH Terms

Conditions

Smoking; Cigarette Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking

Results Point of Contact

• Title: Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
• Organization: Perelman School of Medicine, University of Pennsylvania

audrain@pennmedicine.upenn.edu

(215) 746-7145

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: August 26, 2021
• Primary Completion: February 1, 2024
• Study Completion: May 31, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)