Heated Tobacco Products vs Cigarettes for Tobacco Use

Overseen By Jeffery S Edmiston, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Altria Client Services LLC

Must not be taking: Bronchodilators

Disqualifiers: Malignant tumor, Diabetes, Asthma, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how heated tobacco products compare to regular cigarettes. Researchers aim to understand the levels of harmful chemicals produced when people use these products in a controlled setting. The trial includes different groups, with some using menthol flavors and others using non-menthol. Individuals who have smoked at least five cigarettes daily for over a year and are generally healthy may be suitable for this study. As an unphased study, this trial allows participants to contribute to important research that could influence future tobacco product regulations.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using prescription or over-the-counter bronchodilator medication, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that heated tobacco products like Ploom® might be safer than regular cigarettes because they release fewer harmful chemicals. For Ploom Non-Menthol, studies suggest it exposes users to fewer harmful substances than cigarettes. However, these products still carry some risks.

For Ploom Menthol, research shows similar results. There might be a lower risk compared to smoking cigarettes, but the long-term effects remain unclear. Most studies focus on how these products might affect the lungs and heart.

Both flavors of Ploom® are generally well-tolerated according to research, but they are not risk-free. No tobacco product is completely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because heated tobacco products (HTPs) like Ploom® offer a different smoking experience compared to traditional cigarettes. Unlike cigarettes, which burn tobacco, HTPs heat it, potentially reducing the harmful chemicals produced. This method aims to provide a similar nicotine delivery with possibly fewer health risks. The menthol and non-menthol flavors of Ploom® add variety, which could appeal to different preferences, offering a potentially less harmful alternative for smokers looking to reduce their exposure to harmful substances without quitting nicotine entirely.

What evidence suggests that this trial's treatments could be effective for reducing harmful constituents in tobacco use?

Research has shown that Ploom heated tobacco products (HTPs) might expose users to fewer harmful chemicals than regular cigarettes. In this trial, participants will join different groups to compare these products. Studies indicate that using Ploom can reduce exposure to harmful substances to levels similar to those who quit smoking completely. For people who smoke menthol cigarettes, switching to menthol Ploom HTPs, which participants in this trial may receive, has helped them either stop smoking regular cigarettes or cut down. Overall, early findings suggest that Ploom HTPs could be a less harmful choice compared to traditional cigarettes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

Urine cotinine ≥ 200 ng/mL at Screening

Exclusion Criteria

My diabetes is not well-controlled.

Self-reported puffers

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Group 2 Menthol: Study Product C: Ploom Menthol Flavor Experimental Treatment 1 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 Flavor Experimental Treatment 1 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 Flavor Active Control 1 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 Flavor Active Control 1 Intervention

Subject's menthol UBCC (Usual Brand Combustible Cigarette). Reference product supplied by subject.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841305/

Switching behavior and changes in smoking ... HTP use facilitated switching away from or reducing consumption of combusted cigarettes among adults who smoke, especially when using menthol HTPs.

2. ctv.veeva.com ctv.veeva.com/study/room-air-levels-of-harmful-and-potentially-harmful-constituents-after-heated-tobacco-product-use-and

Room Air Levels of Harmful and Potentially Harmful Constituents ... This study is designed to assess and characterize levels of selected harmful and potentially harmful constituents (HPHCs) and other endpoints of interest in ...

3. kucancercenter.org kucancercenter.org/news-room/news/2022/04/study-to-gauge-effectiveness-of-menthol-e-cigarettes-as-a-quit-smoking-tool

Study to gauge effectiveness of menthol e-cigarettes as a ... Among menthol smokers, they discovered those who used tobacco flavored e-cigarettes were just as likely to successfully switch to e-cigarettes ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8248945/

The Relationship Between Menthol Cigarette Use ... Findings from this study suggest that menthol cigarette use is associated with lower odds of cessation, but not relapse.

5. medicine.umich.edu medicine.umich.edu/dept/psychiatry/news/archive/202504/quitting-menthol-cigarettes-extra-hard-new-u-m-study-will-test-best-way-do-it

Quitting menthol cigarettes is extra hard, but a new U-M study ... Nearly half of Americans who smoke use menthol cigarettes that are harder to quit, driving up their health risks with every puff.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459283/

Heated Tobacco Products: Insights into Composition and ... Currently available HTP toxicity data are mainly on the pulmonary and cardiovascular systems. Moreover, there are no long-term toxicity data and ...

7. ploom.az ploom.az/en/support/faq/is-ploom-x-advanced-safer

Does it mean that Ploom X Advanced is safer than ... Ploom X Advanced is an innovative heated tobacco product which we believe has strong potential as a reduced-risk product compared to smoking cigarettes.

8. withpower.com withpower.com/trial/phase-tobacco-use-5-2024-14b82

Heated Tobacco Products vs Cigarettes for Tobacco Use 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 ...

9. me.ploom.com me.ploom.com/en/support/faq/is-ploom-x-advanced-safer

Does a 90 - 95% substance reduction rate mean that ... NO TOBACCO PRODUCT IS SAFE. * Based on available machine-measured data comparing 9 harmful constituents recommended for reduction in cigarette smoke by the WHO ...