Oral Nicotine Pouches for Tobacco Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests "tobacco-free" oral nicotine pouches to observe how the body absorbs and reacts to them. The goal is to compare different flavors and doses of these pouches with regular cigarettes. Participants will use various nicotine pouches and their preferred brand of cigarettes under controlled conditions. It suits individuals who have been daily smokers for at least a year and aren't currently using other tobacco products. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial may require you to stop taking certain medications if they impact safety, as determined by the investigators or medical staff. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that people generally use nicotine pouches without problems. One study found that users sometimes experience minor issues like dry mouth or throat irritation, but these effects are usually mild and resolve quickly. It's important to note that while the FDA has approved nicotine pouches for sale, they are not specifically approved for smoking cessation. Although considered safer than traditional tobacco products, they are not entirely risk-free. Users should be aware that nicotine is addictive, which means there is a chance of developing a dependence.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these nicotine pouches for tobacco use disorder because they offer a smokeless and potentially safer alternative to traditional cigarettes. Unlike most current treatments like nicotine replacement therapies (patches, gums, lozenges), these pouches provide a variety of flavors—fruit, mint/menthol, and tobacco—which might make them more appealing to users trying to quit smoking. Additionally, the ability to control nicotine intake through low (4mg) and high (8mg) doses gives users flexibility, which could help tailor the transition away from cigarettes to individual needs. This innovative approach combines the familiar sensation of nicotine with the benefits of reduced exposure to harmful combustion products found in cigarettes.
What evidence suggests that this trial's treatments could be effective for tobacco use disorder?
Research has shown that oral nicotine pouches can help people reduce smoking. In this trial, participants will use various flavored nicotine pouches with different nicotine doses. One study found that pouches with 3mg and 6mg strengths significantly reduced cigarette use over four weeks. Another study showed that 41% of people using these pouches quit smoking, while 38% smoked less. These pouches release nicotine, satisfying cravings and helping manage withdrawal without the harmful chemicals in cigarettes. Overall, early findings suggest that nicotine pouches are a promising tool for those looking to quit or cut down on smoking.34678
Who Is on the Research Team?
Tory Spindle, PhD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for healthy adult smokers who smoke daily, have a mild tobacco use disorder, and haven't used other tobacco products or nicotine pouches recently. They must be over 21 years old with normal vital signs and no recent drug use (except THC). Pregnant women, those in another trial within the last month, or using certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete 7 dosing conditions with various nicotine pouches and cigarettes, including controlled and ad libitum use
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cigarette
- Nicotine
Nicotine is already approved in United States, European Union for the following indications:
- Smoking cessation aid
- Nicotine replacement therapy
- Smoking cessation aid
- Nicotine replacement therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator