IQOS (Non-Cigarette Tobacco Product) Pilot Study

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357379
• Other study ID #: Pro00098672
• Status: Completed
• Phase: N/A
• Start date: July 23, 2020
• Est. completion date: October 22, 2020

Study information

• Verified date: October 2021
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cigarettes Per Day	The average percent reduction in cigarettes per day observed in Week 2	Week 2 of study