My Path to Quit Tobacco

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

It had three arms (groups): Standard Intervention (active comparator), Intensive Intervention (experimental) and Intensive Incentivized Intervention (experimental).

The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.

The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.

The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 1550 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: Self-identify as Black. Smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week). Motivated to quit smoking.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: currently taking bupropion for non-smoking cessation reasons.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-07-06 with completion listed for 2030-01.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day (time frame: 26 weeks post-TQD).

It also tracked 7 secondary outcomes, for example Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day, Treatment Satisfaction, Cigarettes per day, Money spent on cigarettes per week and Psychological Distress measured by the 6-item Kessler screener (K6).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1550 people.

With 1550 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.