Heated Tobacco Products for Tobacco Use

Recruiting at 6 trial locations

Overseen By Jeffery S Edmiston, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Altria Client Services LLC

Must not be taking: Bronchodilators, CYP2A6 interactors

Disqualifiers: Diabetes, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 60 days

921 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to those who continue to smoke usual brand combustible cigarettes (UBCC).

Eligibility Criteria

This trial is for adult smokers who are interested in switching from regular cigarettes to heated tobacco products (HTPs). Participants should be currently smoking and willing to switch or abstain as per the study's requirements. Specific details on inclusion and exclusion criteria were not provided.

Inclusion Criteria

Score 5 or higher (moderate dependence or higher) on the FTCD.

Voluntary consent to participate in this study documented on the signed ICF.

I am a woman who cannot have children and had sterilization surgery over 6 months ago.

Exclusion Criteria

My lung function meets the required standards.

Plasma donation within 7 days prior to first check-in.

Elevated liver enzymes at screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either continue smoking, switch to Ploom HTP, or abstain from smoking for 60 days, including 5 days in clinic and a 55-day ambulatory phase

60 days

5 days in clinic, followed by ambulatory phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ploom HTP Menthol HTS; MX3 (681)
• Ploom HTP Tobacco HTS; R8 (120)
• Smoking Abstinence (menthol)
• Smoking Abstinence (non-menthol)

Trial Overview The study is testing changes in exposure to harmful substances when smokers switch from traditional cigarettes to Ploom HTPs, both menthol and non-menthol versions, or choose smoking abstinence. It aims to compare these alternatives with continued use of usual brand combustible cigarettes.

Participant Groups

Group I: Study Product D: Ploom HTP Tobacco HTS; R8 (120) Experimental Treatment 1 Intervention

Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS; R8 (120) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group II: Study Product A: Ploom HTP Menthol HTS; MX3 (681) Experimental Treatment 1 Intervention

Subjects in A arm (Group 1 Menthol) will be required to smoke Ploom HTP Menthol HTS; MX3 (681) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group III: Study Product B: Continue Smoking (menthol) Active Control 1 Intervention

Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group IV: Study Product C: Smoking Abstinence (menthol) Active Control 1 Intervention

Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.

Group V: Study Product E: Continue Smoking (non-menthol) Active Control 1 Intervention

Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group VI: Study Product F: Smoking Abstinence (non-menthol) Active Control 1 Intervention

Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.

Who Is Running the Clinical Trial?

Altria Client Services LLC

Lead Sponsor

Trials

10

Recruited

1,900+

Celerion

Industry Sponsor

Trials

85

Recruited

7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution