Nicotine Pouches for Alcohol Use in Young Adults

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Other tobacco, Cardiac, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 40 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nicotine levels and flavors in oral nicotine pouches might affect alcohol consumption among young adults. Researchers aim to determine if using these pouches changes participants' drinking frequency or quantity. Participants will try various pouches, including high and low nicotine levels in smooth or spearmint flavors, to assess if preferences influence outcomes. Ideal candidates are young adults who use nicotine pouches daily and consume alcohol at least three times a week. As an unphased trial, this study allows participants to contribute to groundbreaking research on lifestyle habits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on nicotine pouch and alcohol use.

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

Research has shown that nicotine pouches might be a safer choice than smoking cigarettes or vaping because they don't contain the same cancer-causing chemicals. However, they still carry risks. Some studies have found harmful substances in these pouches, such as formaldehyde, chromium, and nitrosamines, which could lead to health issues.

Nicotine is a toxic substance that can cause health problems, though serious poisoning from nicotine pouches is rare. Mild poisoning has occurred, but these cases did not become severe. It's important to remember that nicotine is addictive and can affect the heart and nervous system.

In summary, nicotine pouches might be less harmful than traditional tobacco products, but they are not completely risk-free. Anyone considering their use should be aware of these possible health effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nicotine oral pouches for alcohol use in young adults because they offer a novel approach by potentially reducing alcohol consumption through the use of nicotine, a mechanism not typically targeted by standard alcohol use treatments like behavioral therapy or medication. Unlike other treatments, these pouches come in different concentrations and flavors (smooth and spearmint), providing options that might enhance user experience and compliance. Additionally, the use of nicotine pouches is a quick, discreet method that could be more appealing to young adults compared to traditional methods, potentially leading to better adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for alcohol use in young adults?

Research shows that oral nicotine pouches (ONPs) are perceived as less harmful and less addictive than regular tobacco products like cigarettes. This perception might make them more attractive, especially to young people. Studies have found that nicotine pouch use has increased significantly among teens, with about twice as many using them in 2024 compared to 2023. The flavors and nicotine content in these pouches can affect their appeal and users' intentions. Some research found that certain flavors and nicotine levels enhance the pouches' appeal and influence usage intentions. This trial will explore the effects of different nicotine concentrations and flavors on alcohol use in young adults. While ONPs might lower the cancer risk compared to regular tobacco, their impact on alcohol use remains under investigation. ^{6 7 8 9 10}

Who Is on the Research Team?

Brittney L Keller-Hamilton, PhD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for young adults who use both oral nicotine pouches (ONPs) and alcohol. It aims to understand if the concentration of nicotine and flavor in ONPs affects their alcohol consumption, which could influence cancer risk.

Inclusion Criteria

Drink alcohol at least three days/week

I am between 21 and 30 years old.

I use oral nutritional products every day.

Exclusion Criteria

I do not have any major health issues that are not under control.

I have had a heart problem in the last 3 months.

I am not pregnant, planning a pregnancy soon, or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four different types of oral nicotine pouches over four 10-day periods, with ecological momentary assessments and alcohol monitoring

40 days

Daily monitoring with wristband and twice daily assessments

Follow-up

Participants are monitored for next-day side effects and overall safety after each 10-day period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Oral Pouch

Trial Overview The study looks at how different nicotine concentrations and flavors in ONPs might change drinking habits among young adults. Researchers will monitor participants' usage patterns through assessments and surveys to see if these factors lead to increased alcohol intake.

How Is the Trial Designed?

Group I: Low concentration, spearmint-flavored Experimental Treatment 4 Interventions

Participant tries low concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.

Group II: Low concentration, smooth-flavored Experimental Treatment 4 Interventions

Participant tries low concentration, Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.

Group III: High concentration, spearmint-flavored Experimental Treatment 4 Interventions

Participant tries high concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.

Group IV: High concentration, smooth-flavored Experimental Treatment 4 Interventions

Participant tries high concentration Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07095140

Studying the Effects of Nicotine Concentration and Flavor ... This clinical trial studies the use of both (co-use) oral nicotine pouches (ONPs) and alcohol among young adults and whether ONP nicotine concentration and ...

2. keck.usc.edu keck.usc.edu/news/use-of-nicotine-pouches-increases-significantly-among-u-s-teens/

Use of nicotine pouches increases significantly among U.S. ... A team led by Keck School of Medicine of USC researchers found that about twice as many teens used nicotine pouches in 2024 than in 2023.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11199376/

Effects of flavour and modified risk claims on nicotine ... After self-administering each pouch, participants reported appeal, use intentions, and perceived harm compared to cigarettes and e-cigarettes.

4. academic.oup.com academic.oup.com/ntr/article/27/4/598/7693924

Potential Impact of Oral Nicotine Pouches on Public Health Data from nationally representative and population-based youth surveys show lifetime ONP use among adolescents at 3.5%–4.1 % between 2019 and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460324000315

Prevalence and correlates of flavored novel oral nicotine ... Almost 1 in 5 youth reported past month use of flavored novel oral nicotine products. •. Past month use of any other tobacco product was strongly correlated ...

6. 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.

7. yalemedicine.org yalemedicine.org/news/nicotine-pouches

What Parents Should Know About Nicotine Pouches And while nicotine pouches may be a safer alternative to cigarettes or vaping because they don't contain the known carcinogens associated with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417499/

Nicotine pouches: a narrative review of the existing literature Some products contain hazardous substances such as formaldehyde, chromium, and nitrosamines, which may increase the risk of adverse health ...

9. bfr.bund.de bfr.bund.de/cm/349/health-risk-assessment-of-nicotine-pouches.pdf

Health risk assessment of nicotine pouches A few cases of poisoning from nicotine pouch use have been reported but none with a severe course. Nicotine is a toxic, biogenic alkaloid. For ...

10. health.unl.edu health.unl.edu/nicotine-pouches-are-they-safer-chewing-smoking-or-vaping/

Are nicotine pouches safer than chewing, smoking or vaping? There is no data to show nicotine pouches as a safe or effective way to quit. University Health Center medical experts and Nebraska Medicine certified tobacco ...