IQOS (Non-Cigarette Tobacco Product) Pilot Study

NCT04357379 | Completed Results

• 1 other identifier: Pro00098672
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cigarettes Per Day

  Week 2 of study

Study Arms (1)

IQOS group

EXPERIMENTAL

Behavioral: IQOS

Interventions

IQOS BEHAVIORAL

Participants will try an IQOS product and then take home the IQOS to sample for one week.

Also known as: heated tobacco product (HTP)

IQOS group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• additional tobacco use criteria
• additional medical criteria

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Tracy Smith
• Organization: Medical University of South Carolina

smithtra@musc.edu

8437925164

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: July 23, 2020
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)