Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

Plain-language guide to NCT06554873: phase 3 randomized trial of Therapeutic nicotine (patch, non-peptide), 150 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06554873
Phase: phase 3
Status: completed
Start: 2024-08-29
Completion (planned or actual): 2025-12-09
Participants: 150 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Smoking Cessation; Harm Reduction
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Therapeutic nicotine (patch, non-peptide).

It had three arms (groups): Nicotine Non-Responders (experimental), Nicotine Responders - Group 1 (experimental) and Nicotine Responders - Group 2 (experimental).

The registry classes the interventions as drug and other.

Who Took Part

150 actual participants took part.

It was open to people of any sex aged from 22 years up to 65 years.

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

Examples of who could join: Healthy, adult smoker of combustible cigarettes. Age 22 to 65 years at time of screening (verified by government issued ID). Smoke cigarettes for ≥12 months prior to screening. Currently smokes at least 10 tobacco cigarettes per day. Screening eCO ≥ 10 ppm.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: unable to read, speak or understand english; smokes or vapes cannabis more than once a week; cannabis use disorder identification test-revised (cudit-r) score of 8 or greater.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 2024-08-29 with completion listed for 2025-12-09.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Usage of Nicotine Products and Saliva Cotinine Concentrations.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 150 people.

The trial is marked completed; 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.