Heated Tobacco Products for Tobacco Use

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how switching from regular cigarettes to heated tobacco products affects exposure to harmful chemicals. Participants will either continue smoking their usual cigarettes, switch to a heated tobacco product (such as Ploom HTP Menthol HTS; MX3 or Ploom HTP Tobacco HTS; R8), or stop smoking altogether. The study aims to understand the potential health impacts of these smoking alternatives. Individuals who have smoked 10 to 30 cigarettes daily for at least a year and do not plan to quit soon might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the health impacts of smoking alternatives.

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

The trial requires you to stop using certain medications, especially those that interact with cytochrome P450 2A6, within 14 days or 5 half-lives of the drug before starting the study. If you're taking any medications, it's best to discuss them with the study team to see if they are allowed.

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

Research has shown that Ploom heated tobacco products (HTPs) expose users to fewer harmful substances than regular cigarettes. For instance, Ploom X Advanced, a similar product, reduces nine toxic substances by 90-95%. However, no tobacco product is completely safe.

Most available research on HTPs examines their effects on the lungs and heart. Studies have found that HTPs can still increase blood pressure and heart rate and affect blood clotting. Information on their long-term safety remains limited.

In summary, while Ploom HTPs might be less harmful than traditional cigarettes, they still pose health risks. Participants should consider these potential risks before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these heated tobacco products because they offer a potentially reduced-risk alternative to traditional smoking. Unlike regular cigarettes, which burn tobacco to deliver nicotine, these products heat the tobacco instead, which might result in fewer harmful chemicals being released. By exploring both menthol and non-menthol options, this trial aims to see if these products can effectively satisfy smokers' cravings while potentially lowering the health risks associated with smoking.

What evidence suggests that this trial's treatments could be effective for reducing exposure to harmful constituents in smokers?

Research has shown that heated tobacco products (HTPs), such as Ploom, might expose users to fewer harmful substances than regular cigarettes. In this trial, participants will join different arms to evaluate the effects of both menthol and non-menthol HTPs. Some studies suggest that using these HTPs could help reduce harm for smokers. However, evidence is insufficient to prove that HTPs are less harmful overall or that they aid in quitting smoking. These products might release fewer toxic chemicals because they don't burn the tobacco. Scientists continue to study the effectiveness of these products in reducing harm, and more information is needed for clear conclusions. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12385413/

The Health Effects of Heated Tobacco Product Use—A ... There is currently insufficient evidence that using HTPs is less harmful than smoking traditional tobacco products, nor is there any evidence ...

2. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06356610/

Trial | NCT06356610 This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs (2 menthol varieties, Products ...

3. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/tobaccocontrol/early/2025/04/16/tc-2024-059000.full.pdf

a systematic review and meta Data on 143 BoPH indicated short- term HTP use had mixed effects compared with cigarettes, e- cigarettes and smoking abstinence. The rate of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8733777/

Heated tobacco products for smoking cessation and reducing ... No studies reported on cigarette smoking cessation, so the effectiveness of heated tobacco for this purpose remains uncertain. There was insufficient evidence ...

5. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01170-7

Switching behavior and changes in smoking behavior by ... Our results suggest that the combined availability of both menthol and non-menthol HTPs may offer an increased tobacco harm reduction ...

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 has a 90-95% reduction in 9 toxic substances, but it is not considered safe, and no tobacco product is safe.

8. withpower.com withpower.com/trial/phase-tobacco-use-9-2023-073d8

Heated Tobacco Products for Tobacco Use Trial Overview The study is testing changes in exposure to harmful substances when smokers switch from traditional cigarettes to Ploom HTPs, both menthol and ...

9. pmiscience.com pmiscience.com/en/products/heated-tobacco/

Heated Tobacco Products HTPs are designed to heat tobacco instead of burning it, generating as a result an aerosol with significantly lower levels of harmful chemicals compared with ...