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Heated Tobacco Products vs Cigarettes for Tobacco Use
N/A
Recruiting
Research Sponsored by Altria Client Services LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reports at the Screening Visit smoking at least 5 non-menthol or menthol combustible cigarettes per day for at least 12 months prior to Screening
Be older than 18 years old
Must not have
Uncontrolled diabetes mellitus
Females with specific pregnancy-related conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 1
Awards & highlights
Summary
"This trial will compare the levels of harmful substances in the air of a closed environment after people use Ploom heated tobacco products and traditional cigarettes. The study will focus on both menthol and non-ment
Who is the study for?
This trial is for adult smokers who regularly use either non-menthol or menthol cigarettes. Participants will be using different tobacco products in a controlled environment to measure air levels of harmful substances.
What is being tested?
The study compares the environmental impact of Ploom® heated tobacco products (HTP) and usual brand combustible cigarettes (UBCC), both in menthol and non-menthol flavors, by measuring harmful constituents in room air after use.
What are the potential side effects?
Since this trial involves the use of tobacco products, potential side effects include those typically associated with smoking such as coughing, throat irritation, and increased risk of respiratory issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been smoking at least 5 cigarettes daily for the past year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes is not well-controlled.
Select...
I am a female with a pregnancy-related condition.
Select...
I don't have any other cancer or serious health conditions.
Select...
I have a history of heart failure.
Select...
I have had a fever at my screening or during my visits.
Select...
I haven't needed medication for an acute illness in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
3-ethenylpyridine (3-EP) (mg/ m3)
Acetaldehyde (µg/ m3)
Air Exchange Rate (AER)
+25 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 Menthol: Study Product C: Ploom Menthol FlavorExperimental Treatment1 Intervention
Heated Tobacco Product (HTP) denoted as Ploom PX1.5TN HTP; Menthol HTS (Heated Tobacco Stick); MX3. Test product sourced from Japan Tobacco Inc.
Group II: Group 1 Non-Menthol: Study Product A, Ploom Non-Menthol FlavorExperimental Treatment1 Intervention
Heated Tobacco Product (HTP) denoted as Ploom PX1.5TN HTP; Tobacco HTS (Heated Tobacco Stick); R8. Test product sourced from Japan Tobacco Inc.
Group III: Group 1 Non-Menthol: Study Product B, UBCC Non-Menthol FlavorActive Control1 Intervention
Subject's Non-menthol UBCC (usual brand combustible cigarette). Reference product supplied by subject.
Group IV: Group 2 Menthol: Study Product D: UBCC Menthol FlavorActive Control1 Intervention
Subject's menthol UBCC (Usual Brand Combustible Cigarette). Reference product supplied by subject.
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Who is running the clinical trial?
ICON Clinical ResearchIndustry Sponsor
50 Previous Clinical Trials
15,216 Total Patients Enrolled
Altria Client Services LLCLead Sponsor
8 Previous Clinical Trials
1,758 Total Patients Enrolled
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