Free Samples for Health

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Electric Toothbrush (active comparator) and Nicotine Replacement Therapy (experimental).

Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.

The registry classes the interventions as behavioral and drug.

Who Took Part

1239 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: ≥ 18 years old. Smokes at least 1 combustible cigarette per day on at least 25 days of the month.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: does not own a smartphone with internet access; myocardial infarction or stroke in the past 3 months; pregnant or breastfeeding.

How the Study Was Run

Design: randomized, factorial and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2023-06-12 with completion listed for 2025-06-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-day Biochemically Confirmed Point Prevalence Abstinence (time frame: 6 months post baseline).

It also tracked 7 secondary outcomes, for example 7-day Self-reported Point Prevalence Abstinence, 7-day Self-reported Point Prevalence Abstinence, 24-hour Intentional Quit Attempts, Smoking Heaviness, Nicotine Replacement Therapy Utilization and Perceived Nicotine Replacement Therapy Safety.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1239 people.

With 1239 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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