CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Tobacco product administration and assessmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05499377
NCT05499377N/ACompleted

Effects of Heated Tobacco Product Flavor on Tobacco Use Behavior and Abuse Liability Among Menthol Cigarette Smokers

Virginia Commonwealth University·interventional·Posted Aug 12, 2022·Updated Jan 31, 2025

In Brief

A clinical study evaluating Tobacco product administration and assessment for Tobacco Use. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 12, 2022
Enrollment StartNov 28, 2022
Primary CompletionSep 22, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.9 years ago

Interventions

Tobacco product administration and assessmentdevice

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).