90 Participants Needed

Heated Tobacco Products vs Cigarettes for Tobacco Use

JS
Overseen ByJeffery S Edmiston, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Altria Client Services LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study is designed to assess and characterize levels of selected harmful and potentially harmful constituents (HPHCs) and other endpoints of interest in an environmental chamber (EC) after ad libitum use of Ploom® heated tobacco product (HTP) and combustible cigarettes (CC) in their respective group (menthol and non-menthol smokers) by adults who smoke (AS).

Eligibility Criteria

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.

Inclusion Criteria

I am using approved birth control methods.
Able to communicate effectively with the study personnel and willing to comply with the requirements of the study
I am generally healthy with no major health issues as per my recent medical checks.
See 7 more

Exclusion Criteria

My diabetes is not well-controlled.
Any other condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
Self-reported puffers
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Product Trial

Subjects participate in a 2-hour product trial to try the Ploom HTP with non-menthol or menthol Ploom HTS.

1 day
1 visit (in-person)

Chamber Test Sessions

Subjects participate in environmental chamber sessions to assess air quality after using study products.

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Study Product A: Ploom® Non-Menthol Flavor
  • Study Product B: Usual Brand Combustible Cigarette (UBCC) Non-Menthol Flavor
  • Study Product C: Ploom® Menthol Heated Tobacco Product (HTP)
  • Study Product D: Usual Brand Combustible Cigarette (UBCC) Menthol Flavor
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Altria Client Services LLC

Lead Sponsor

Trials
10
Recruited
1,900+

ICON Clinical Research

Industry Sponsor

Trials
52
Recruited
15,100+
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