IQOS (Non-Cigarette Tobacco Product) Pilot Study

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04357379
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking; Tobacco Use	Behavioral: IQOS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Impact Of IQOS Non-Cigarette Tobacco Product On Reinforcement Value and Use In Current Smokers
• Actual Study Start Date: Jul 23, 2020
• Actual Primary Completion Date: Oct 22, 2020
• Actual Study Completion Date: Oct 22, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Prefer IQOS [Lab Visit 2, occurring approximately one week after the initial screening/baseline visit]

   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

Secondary Outcome Measures

1. Cigarettes Per Day [Week 2 of study]

   The average percent reduction in cigarettes per day observed in Week 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 18, 2020
• Informed Consent Form - Aug 21, 2020

More Information

Publications

None provided.

• Responsible Party: Tracy Smith, Assistant Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT04357379
• Other Study ID Numbers: Pro00098672
• First Posted: Apr 22, 2020
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	IQOS Group
Arm/Group Description	IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	IQOS Group
Arm/Group Description	IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.6 (11.0)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 10%
White	7 70%
More than one race	2 20%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Prefer IQOS
Description	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
Time Frame	Lab Visit 2, occurring approximately one week after the initial screening/baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IQOS Group
Arm/Group Description	IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Measure Participants	10
Count of Participants [Participants]	7 70%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IQOS Group
Arm/Group Description	IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
Measure Participants	10
Mean (Standard Deviation) [Percentage reduction in cigs per day]	16.1 (32.7)

Adverse Events

Time Frame	2 weeks
Adverse Event Reporting Description	Interviewer-administered assessment at each visit
Arm/Group Title	IQOS Group
Arm/Group Description	IQOS: Participants will try an IQOS product and then take home the IQOS to sample for one week.
All Cause Mortality
	IQOS Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	IQOS Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	IQOS Group
	Affected / at Risk (%)	# Events
Total	3/10 (30%)
General disorders
Cough	1/10 (10%)	2
Headache	1/10 (10%)	1
Nausea	1/10 (10%)	1
ER visit for medication refill	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.