Heated Tobacco Products for Tobacco Use

No longer recruiting at 2 trial locations

Overseen By Jeffery S Edmiston

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Altria Client Services LLC

Must not be taking: Bronchodilators, Antibiotics, CYP2A6 inhibitors

Disqualifiers: Malignant tumors, Diabetes, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different heated tobacco products (HTPs) affect nicotine levels in the body and user experiences compared to regular cigarettes and nicotine gum. Participants will try four flavors of HTPs, available in both menthol and non-menthol options. This trial may suit adults who have smoked 10 to 30 factory-made cigarettes daily for at least a year. Participants will spend 34 days in the study, including a 28-day screening period and a 6-day stay at the clinic. As an unphased trial, this study offers a unique opportunity to contribute to research on alternative smoking products.

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

The trial requires that you do not use certain medications that interact with a specific enzyme (cytochrome P450 2A6) within 14 days before starting the study. If you are taking any of these medications, you may need to stop or adjust them before participating.

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

Studies have shown that heated tobacco products (HTPs) can be linked to certain health concerns. Research suggests that people who use HTPs might face a higher risk of developing breathing problems. Reports also indicate that using multiple tobacco products, including HTPs, increases the risk of nicotine addiction and other health issues.

However, the long-term health effects of HTPs, such as cancer risk, remain unclear due to insufficient long-term studies.

Overall, while HTPs may pose some safety concerns, more research is needed to fully understand their impact on health. Participants should consider these factors when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about heated tobacco products as a unique approach to tobacco use because they provide an alternative to traditional smoking methods. Unlike conventional cigarettes, which burn tobacco to produce smoke, heated tobacco products heat the tobacco to release a nicotine-containing vapor without combustion. This method potentially reduces the exposure to harmful chemicals found in cigarette smoke. Additionally, these products can offer users a similar sensory experience to smoking, which might make them more appealing for those looking to quit or reduce smoking. By exploring various product sequences and usage patterns, researchers hope to understand their impact on tobacco use behavior and harm reduction.

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

Research has shown that heated tobacco products (HTPs) have not been proven to help people quit smoking. Some studies suggest that using HTPs might make quitting more difficult in the long run. However, evidence indicates that HTPs can lead to smoking fewer regular cigarettes or stopping temporarily. While this might reduce harm from smoking, it is not equivalent to quitting. The effectiveness of HTPs for quitting smoking remains unclear, and further research is needed. Participants in this trial will follow different sequences of test and reference HTPs to investigate their impact on smoking behavior. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adult smokers aged 22 to 65 who regularly use menthol or non-menthol cigarettes. Participants should be interested in trying heated tobacco products (HTPs) and willing to stay in a clinic for six days. Specific eligibility criteria are not provided, but typically include general health requirements and no conflicting medications or conditions.

Inclusion Criteria

Participants must be informed of the nature and risks of the study and voluntarily give written informed consent prior to screening

Negative pregnancy test at screening and Check-in for all female participants

I am using birth control and can have children.

Exclusion Criteria

Unwilling or unlikely to comply with the requirements of the study

My BMI is either above 40 or below 18.

Participant or a first-degree relative is a current or former employee of the tobacco industry or a named party in litigation with a tobacco company

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

28 days

1 visit (in-person), 5-day at-home product trial

Enrollment and Acclimation

Participants receive Ploom® HTP products for at-home acclimation and training on device use

5 days

1 visit (in-person)

In-clinic Confinement and Product Use

Participants use assigned products in a controlled environment with PK and subjective effects assessments

6 days

Daily sessions (in-clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heated Tobacco Products

Trial Overview The study tests the nicotine delivery and user response of different HTPs compared with regular cigarettes and nicotine gum. It's a controlled study where each participant will try multiple products (2 menthol, 2 tobacco flavors, their usual cigarette brand, and nicotine gum) over several sessions.

How Is the Trial Designed?

Group I: Randomization Sequence 6: FAEBDC Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Reference Product F Test Product A Reference Product E Test Product B Test Product D Test Product C

Group II: Randomization Sequence 5: EFDACB Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Reference Product E Reference Product F Test Product D Test Product A Test Product C Test Product B

Group III: Randomization Sequence 4: DECFBA Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product D Reference Product E Test Product C Reference Product F Test Product B Test Product A

Group IV: Randomization Sequence 3: CDBEAF Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product C Test Product D Test Product B Reference Product E Test Product A Reference Product F

Group V: Randomization Sequence 2: BCADFE Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product B Test Product C Test Product A Test Product D Reference Product F Reference Product E

Group VI: Randomization Sequence 1: ABFCED Experimental Treatment 6 Interventions

Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6 day in-clinic period in following order: Test Product A Test Product B Reference Product F Test Product C Reference Product E Test Product D

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/PMC8733777/

Heated tobacco products for smoking cessation and reducing ... Authors' conclusions. No studies reported on cigarette smoking cessation, so the effectiveness of heated tobacco for this purpose remains uncertain.

2. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/33/4/472

Heated tobacco products do not help smokers quit or prevent ... HTP use was also linked to a decreased likelihood of longer-term (≥6 months) cessation among established smokers aged 20–29 years and full-time workers. These ...

3. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Comparison-of-attempts-and-plans-to-quit-tobacco-products-among-single-dual-and-triple,169663,0,2.html

Comparison of attempts and plans to quit tobacco products ... Research suggests that successful smoking cessation is psychologically linked to reduced depression, anxiety, and stress, as well as an improved ...

4. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01000-2

A reduced exposure heated tobacco product was introduced ... This study demonstrates reduction or elimination of combustible cigarette smoking while adults were using HTPs and some increased smoking after market removal.

5. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats In 2020, 8.5% of adult current smokers successfully quit smoking in the past year, up from 7.5% in 2018.

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

The Health Effects of Heated Tobacco Product Use—A ... The studies suggest a positive correlation between HTP use and the occurrence of respiratory diseases, with particular negative effects observed ...

7. cdc.gov cdc.gov/tobacco/other-tobacco-products/heated-tobacco-products.html

Heated Tobacco Products | Smoking and Tobacco Use Use of multiple tobacco products is associated with increased risk for nicotine dependence and adverse health effects.

8. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/A-scoping-review-of-the-toxicity-and-health-impact-of-IQOS,188867,0,2.html

A scoping review of the toxicity and health impact of IQOS This work aims to summarize the current evidence on the toxicity and health impact of IQOS, taking into consideration the data source.

9. tobaccoinaustralia.org.au tobaccoinaustralia.org.au/chapter-18-e-cigarettes/indepth-18b-non-combustible-cigarettes/18b-6-health-effects-of-heated-tobacco-products

18B.6 Health effects of heated tobacco products These data show that: 1) many trials are using biomarkers that are inappropriate for predicting lung cancer risk, and 2) the most relevant biomarkers mostly ...

10. dkfz.de dkfz.de/fileadmin/user_upload/Krebspraevention/Download/pdf/FzR/FoS_2024_Heated-Tobacco-Products.pdf

Health Risks of Heated Tobacco Products The long-term adverse health effects of using HTPs, particularly the cancerogenic risks, are currently unknown due to the lack of reliable long-term studies ...