Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Arm I (oral nicotine pouch) (experimental) and Arm II (nicotine replacement therapy) (active comparator).

The registry classes the interventions as other.

More on the Plan

Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT.

Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT.

Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT.

OUTLINE: Participants are randomized to 1 of 2 arms.

Who Took Part

The registry lists 1000 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Read and speak English. 21 years or older. Smoke ≥ 5 cigarettes per day for the past year. Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT). Live in a rural Appalachian County.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: report currently using smoking cessation medications, nrt, or actively seeking treatment for smoking cessation; use of onps in past 3 months; use of nicotine replacement therapies in past 3 months.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-06-13 with completion listed for 2028-12-31.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Biochemically verified 7-day point prevalence abstinence from cigarettes (time frame: At the end of the 12- week switch phase). Complete switching rate (Aim 1) (time frame: At the end of the 12-week switch phase). Abstinence from cigarettes (Aim 1) (time frame: At the end of the 12-week switch phase).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1000 people.

With 1000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.