A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products

Summary

This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with three variants of HTP consumables ("sticks,"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1).

In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.

Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.

Conditions

• Smoking Cigarette

Interventions

OTHER

RDTH002581

Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.

OTHER

RDTH002580

Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.

OTHER

RDTH002582

Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.

OTHER

RDTH002578

Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.

OTHER

RDTH002577

Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.

OTHER

RDTH002579

Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.

Sponsors & Collaborators

• IPSOS

  collaborator INDUSTRY

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Melissa Tapia, Ph.D. · RAI Services Company

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2025-09-12

Completion

2025-09-25

Countries

• United Kingdom

Study Locations