Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

Nicotine Pouches for Smoking

No longer recruiting at 4 trial locations

Overseen ByJohn Darnell

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Anticoagulants, Smoking cessation aids

Disqualifiers: Diabetes, Cancer history, Hypertension, others

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

Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effects of switching to nicotine pouches on certain health markers in smokers, against those who continue smoking cigarettes or stop smoking altogether. Participants will use varying strengths of nicotine pouches to observe their impact over five days. Smokers who rely on cigarettes as their primary nicotine source and smoke at least 10 cigarettes daily may qualify for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could shape future smoking cessation strategies.

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

The trial requires you to stop taking certain medications, like anti-inflammatory drugs and substances affecting liver enzymes, at least 14 days before starting. If you're using medications for smoking cessation, you must stop them 30 days before joining. 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 nicotine pouches are generally easy to use. One study found that 41% of users successfully quit smoking with them, while 38% reduced their smoking. However, 20.9% did not find them helpful for quitting or reducing smoking.

Another study examined 31 samples of nicotine pouches to assess their safety. The results suggested that these pouches might be safer than traditional smoking due to potentially fewer health risks.

Overall, while success rates vary, nicotine pouches are considered a safer choice than smoking and might help reduce the harm associated with tobacco use.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about nicotine pouches because they offer a smoke-free alternative for smokers looking to quit or reduce smoking. Unlike traditional nicotine replacement therapies like patches, gums, or lozenges, nicotine pouches provide a discreet, spit-free option that doesn't involve inhaling smoke or vapor. They come in various nicotine strengths, allowing for a more tailored approach to nicotine consumption, which could help manage cravings more effectively. This method could potentially provide a less harmful way to satisfy nicotine cravings while reducing exposure to the harmful chemicals found in cigarette smoke.

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

Research has shown that nicotine pouches, a treatment under study in this trial, can help people smoke fewer cigarettes. In some studies, smokers who used these pouches reduced their smoking over a few weeks. Most people tolerate these pouches well and experience no major problems. However, while they help reduce smoking, they might not significantly decrease the risks associated with tobacco. The pouches provide nicotine, which can satisfy cravings and lessen the urge to smoke. Overall, nicotine pouches could be a helpful tool for those wanting to cut down on smoking.¹ ⁴ ⁶ ⁷ ⁸

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 who want to switch from regular cigarettes to nicotine pouches or try smoking abstinence. Specific details on eligibility criteria are not provided, but typically participants must meet certain health standards and be willing to follow the study's protocol.

Inclusion Criteria

Agrees to use assigned IP throughout the study period

Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening

Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening

See 11 more

Exclusion Criteria

Systolic blood pressure (BP) of > 160 mmHg or a diastolic BP of > 95 mmHg

My hemoglobin level is below the normal range for my gender.

I haven't used smoking cessation aids in the last 30 days.

See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are switched to exclusive use of nicotine pouches or continue smoking their usual brand cigarettes or abstain from smoking for 5 days

5 days

In-clinic stay

Follow-up

Participants are monitored for changes in biomarkers of exposure after the treatment phase

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

Nicotine Pouch

Trial Overview

The study is testing how switching from usual brand cigarettes to different strengths of nicotine pouches (4 mg, 8 mg, 10 mg, and 12 mg) or stopping smoking affects exposure to certain harmful chemicals. Participants will be randomly assigned to one of these new options or continue with their regular smoking habits for five days in a clinic setting.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Active Control

Group I: Smoking AbstinenceExperimental Treatment1 Intervention

Subjects will not use any tobacco or nicotine containing products.

Group II: Continued UB cigarette smokingExperimental Treatment1 Intervention

Subjects will continue use of their Usual Brand Cigarettes.

Group III: Nicotine Pouch P1312914, 4 mg nicotineActive Control1 Intervention