IQOS (Non-Cigarette Tobacco Product) Pilot Study

Impact Of IQOS Non-Cigarette Tobacco Product On Reinforcement Value and Use In Current Smokers

A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use
• Intervention / Treatment: Behavioral: IQOS

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• daily cigarette smoker
• interested in using non-cigarette tobacco product
• have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

Exclusion Criteria:

• additional tobacco use criteria
• additional medical criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IQOS group	Behavioral: IQOS; Participants will try an IQOS product and then take home the IQOS to sample for one week.; Other Names: heated tobacco product (HTP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Prefer IQOS	Participants complete a preference assessment in which they choose between the IQOS or a traditional cigarette in a series of trials. The outcome of this assessment is the number of participants who prefer the IQOS over a traditional cigarette	Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarettes Per Day	The average percent reduction in cigarettes per day observed in Week 2	Week 2 of study

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): October 22, 2020
• Study Completion (Actual): October 22, 2020

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00098672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No