Nicotine Oral Product for Smoking

No longer recruiting at 1 trial location

Overseen By Emily Smith

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Smoking cessation aids

Disqualifiers: Diabetes, Cancer, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a modern nicotine oral product affects smokers, focusing on nicotine absorption and the product's potential for misuse. Participants will use eight different nicotine products and report their experiences. The trial seeks generally healthy smokers who have smoked at least 10 cigarettes a day for six months and are willing to try different nicotine products. As an unphased trial, it offers participants the opportunity to contribute to important research on nicotine products and their effects.

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

The trial does not specify if you need to stop taking your current medications, but you cannot use any medication or substance that helps with quitting smoking within 30 days before joining. It's best to discuss your specific medications with the study team.

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

Research shows that nicotine oral products, like the one under study, are generally well-tolerated. Studies have found no evidence of increased risks, such as oral diseases like cancer or gum problems, associated with these products. While no tobacco product is completely safe, past research has not shown serious side effects. Safety checks continue, but current data suggests that these nicotine products do not cause significant short-term harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the modern nicotine oral product for smoking because it offers a new way to reduce smoking dependence by utilizing a novel delivery method. Unlike traditional nicotine replacement therapies like patches, gums, or lozenges, this product provides an innovative oral delivery that may offer faster craving relief and more user-friendly administration. Additionally, its potential for customizable dosage and varied usage patterns could better align with individual needs, making quitting smoking more manageable for different types of smokers. This versatility and personalization make it a promising addition to current smoking cessation options.

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

Research has shown that modern nicotine oral products, which participants in this trial will use, can help reduce cigarette consumption. One study found that using these oral pouches led to a noticeable drop in the number of cigarettes smoked over four weeks. However, this reduction did not significantly decrease the harm caused by tobacco. Another study found that these pouches deliver nearly as much nicotine as a cigarette, providing about 91.73% of the nicotine exposure. This suggests they might be a less harmful option for smokers not ready to quit completely. ^{6 7 8 9 10}

Who Is on the Research Team?

Brian Keyser, PhD

Principal Investigator

Reynolds American

Are You a Good Fit for This Trial?

This trial is for generally healthy smokers aged 21-60 who also use smokeless tobacco products. They must have smoked at least 10 cigarettes a day for the past 6 months, be willing to use specific nicotine products during the study, and stay in-clinic for ten days. Pregnant women or those on certain medications are excluded.

Inclusion Criteria

I have used smokeless tobacco products within the last 30 days.

Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English

Exclusion Criteria

Individuals or their family members that have ongoing litigation with tobacco company(ies)

Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day -1

I weigh 110 pounds or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 45 days

1 visit (in-person)

In-Clinic Confinement

Participants are confined for 10 days to evaluate elements of abuse liability of nicotine products

10 days

Continuous in-clinic stay

Test Sessions

Participants evaluate one investigational product in each of eight separate test sessions, including subjective and physiological measures

8 days

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the test sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modern Nicotine Oral Product

Trial Overview The study tests eight different oral nicotine products (Product A to N) to see how they affect users' desire and body reactions compared to their usual smoking habits. It's an open-label study where participants know what they're using, with each trying all options in random order.

How Is the Trial Designed?

Group I: Product usage order NGAFBECD Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group II: Product usage order GFNEADBC Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group III: Product usage order FEGDNCAB Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group IV: Product usage order EDFCGBNA Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group V: Product usage order DCEBFAGN Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VI: Product usage order CBDAENFG Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VII: Product usage order BACNDGEF Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Group VIII: Product usage order ANBGCFDE Experimental Treatment 8 Interventions

Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session

Who Is Running the Clinical Trial?

RAI Services Company

Lead Sponsor

Trials

43

Recruited

7,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12377922/

The Effects of Oral Nicotine Pouches on Cigarette Smoking ... Though oral nicotine pouches significantly reduced cigarette smoking over 4 weeks, they did not decrease tobacco-related harm exposure, likely ...

2. nature.com nature.com/articles/s41598-025-21812-x

Evaluation of high-nicotine oral products shows potential to ... Modern oral nicotine delivery (MOND) offers potentially reduced harm nicotine delivery for adult smokers who do not wish to quit.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70193?af=R

Nicotine pouches and clinical outcomes related to smoking ... First, while a 2-week crossover study showed that NPs reduced the number of cigarettes smoked, this reduction was similar to that achieved with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000721

Nicotine Pouch Pharmacokinetics Compared to Smoked ... A meta-analysis of three trials showed that 4 mg pouches delivered 91.73% (95% CI 85.03%–98.42%) of cigarette total nicotine exposure. Peak ...

5. publications.aap.org publications.aap.org/pediatrics/article/155/6/e2024070312/201951/Oral-Nicotine-Product-Use-and-Vaping-Progression

Oral Nicotine Product Use and Vaping Progression Among ... Across a total of 1173 observations, there were 277(23.7%) observations of any past 6-month ONP use (17.4% nicotine pouch and 21.3% other ONPs).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8887571/

The New Nicotine Pouch Category: A Tobacco Harm ... Examples of new product categories are electronic cigarettes, heat-not-burn products, and nicotine pouches (NP). This commentary discusses the oral NP category.

7. cdc.gov cdc.gov/tobacco/nicotine-pouches/index.html

Nicotine Pouches | Smoking and Tobacco Use Get the facts about nicotine pouches and their health effects. The bottom line. There are no safe tobacco products, including nicotine pouches.

8. nature.com nature.com/articles/s41415-023-6383-7

Nicotine pouches: a review for the dental team There is no reported evidence of increased oral disease (cancer, caries, periodontal disease) with orally administered NRT. Numerous laboratory- ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2214750024001628

Beyond smoking: Risk assessment of nicotine in pouches This study aims to assess nicotine in pouches and potential risks for health damage. 31 samples of nicotine pouches were collected and analyzed.

10. jpccr.eu jpccr.eu/pdf-189645-114568

The safety of using oral nicotine pouches Monitoring potential oral cavity harmful effects and gathering clinical data are crucial for validating. ONPs as nicotine replacement therapy.