The Abuse Liability of a Novel Heated Tobacco Product (IQOS) and Its Feasibility as a Menthol Cigarette Substitute

NCT05499377 | Completed Results FDA Device

• 3 other identifiers: HM200248731F30DA057047U54DA036105
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This project examines the influence of flavor availability on switching to an MRTP known as IQOS, part of the Heated Tobacco Product (HTP) class, among menthol smokers using clinical lab and naturalistic evaluations of abuse liability. Results will help federal regulators predict the public health impact on menthol cigarette smokers of policies restricting access to menthol-flavored HTPs.

Conditions

Tobacco Use

Keywords

Heated Tobacco Products; Flavor; Abuse Liability; Tobacco; Cigarettes; Menthol; Experimental Tobacco Marketplace; Nicotine Delivery; Puff Topography; Ecological Momentary Assessment; Modified Risk Tobacco Product; IQOS; Heated Tobacco Products Flavors

Outcome Measures

Primary Outcomes (3)

• Percent Change in Average Daily Cigarette Use Per Day From Baseline

  Average number of cigarettes consumed per day, collected via daily text/email survey, averaged overconsumption for Tues-Thurs of each week. Outcome will compare the percent change in cigarette consumption from the baseline week (OB menthol cigarette use) to the intervention week (IQOS use) between the two study arms.

  Week 1 (baseline) to Week 2 (intervention)

• Percent Increase in Demand as the Subject is Willing to Substitute From Cigarettes to HTPs Using the Experimental Tobacco Marketplace Task

  Participants will complete the Experimental Tobacco Marketplace Task - which asks participants to allocate a hypothetical budget across a large menu of products. In each session, cigarette prices increased ($0.12, $0.25, $0.50, $1.00. and $2.00 per cigarette) while prices for alternative products remained fixed. Across three ETM sessions, either all products, all products except little cigars and cigarillos (LCCs), or all products except ENDS (JUUL e-cigarettes) were available. Linear regression is performed on individual participant data using log-transformed cigarette price to determine demand and substitution. Reported demand for tobacco products is used to determine substitution between IQOS and cigarettes. Purchasing decisions are not reinforced. Outcome will compare the cross-price elasticity (CPE) of IQOS with respect to menthol cigarettes among those with access to IQOS-menthol and IQOS-Tobacco (IQOS-M group) compared to those with access to IQOS-tobacco only (IQOS-T group).

  Week 2, Friday Clinical Lab visit

• Plasma Nicotine Delivery

  Change in the plasma nicotine levels from before to after a standardized 10-puff (30-sec interpuff interval) bout with IQOS in the participant's assigned flavor. Outcome will compare the average plasma nicotine boost (the change in plasma nicotine levels from before to after the standardized puffing bout) across two study arms as well as compared to own-brand menthol cigarettes.

  Week 2, Friday Clinical Lab visit (10 puff bout period)

Secondary Outcomes (3)

• Cigarette Craving Suppression Questionnaire

  Week 2, Friday Clinical Lab Visit (10 puff bout period)

• Puff Topography (Puff Duration)

  Week 2, Friday Clinical Lab visit (10 puff bout period)

• Average Daily IQOS Usage

  Week 2 (intervention week), Tuesday-Thursday

Study Arms (2)

Tobacco-Flavored IQOS

ACTIVE COMPARATOR

Tobacco - where menthol smokers will only have access to tobacco-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System

Device: Tobacco product administration and assessment

Menthol-Flavored IQOS

EXPERIMENTAL

Menthol - where menthol smokers will only have access to menthol-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System

Device: Tobacco product administration and assessment

Interventions

Tobacco product administration and assessment DEVICE

Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 2 HTP flavor conditions (tobacco-flavored HeatSticks or Fresh Menthol-flavored HeatSticks), with equal probability and provided with a supply of their condition specific HTP and asked to use it in place of their usual menthol cigarettes for the next week. Participants use their own brand menthol cigarettes and assigned HTP both at home (naturalistic use) and in the clinical laboratory (two visits/week).

Menthol-Flavored IQOS; Tobacco-Flavored IQOS

Eligibility Criteria

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

You may qualify if:

• Healthy adults (aged 21 and older)
• Daily menthol cigarette smokers
• Exhaled Carbon Monoxide (CO) reading of \> 5 PPM at in-person screening (to confirm smoking status)
• A 'positive' cotinine cassette result to verify nicotine use at the in-person screening.
• Participants must be willing to provide informed consent and abstain from nicotine/tobacco for ≥8 hours prior to each lab session.
• Participants must have access to a computer/smartphone and be willing to receive and respond to daily surveys
• Able to read and write in English

You may not qualify if:

• Daily use of any tobacco products other than cigarettes
• Self-reported history of chronic medical or psychiatric conditions
• Women will be excluded if they test positive for pregnancy (by urinalysis) or self-report breastfeeding.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• White AM, Imran R, Gaitan N, Bickel WK, Perera RA, Cobb CO, Eissenberg TE, Barnes AJ. A Pilot RCT Exploring Heated Tobacco Product Substitution for Menthol Cigarettes. Am J Prev Med. 2025 Nov;69(5):108029. doi: 10.1016/j.amepre.2025.108029. Epub 2025 Aug 5.

  PMID: 40763831 DERIVED

MeSH Terms

Conditions

Tobacco Use

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Augustus Whiet
• Organization: Virginia Commonwealth University

whiteam25@vcu.edu

(804) 828-8892

Study Officials

• Andrew J Barnes, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: November 28, 2022
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)