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Plain-language guide to NCT07089901: phase 4 interventional trial of Therapeutic nicotine (patch, non-peptide), 600 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07089901
Phase
phase 4
Status
recruiting participants
Start
2026-05-06
Completion (planned or actual)
2030-03-31
Participants
600 (estimated)
Design
na, open label (everyone knows who gets what), other
Conditions studied
Smoking
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

Tobacco use is a chronic relapsing condition.

It had 1 arm (groups): study group (experimental).

All participants will receive transdermal nicotine replacement therapy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 600 planned participants were the target.

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

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

Examples of who could join: 21 years of age or older;. Smoke ≥ 10 cigarettes/day. Smoking daily for ≥ 2 years, with a stable smoking pattern for the past 6 months;. Intention to quit smoking and set a target quit date in the next 1 month;. Have an iPhone or Android smartphone capable of running the photoEMA and iCO software.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: pregnant, breastfeeding, or planning to become pregnant during the course of the study;; currently in smoking cessation treatment or current use of smoking cessation products;; regular use (i.e. \>9 days/month) of non-cigarette nicotine-containing products (e.g. cigarillos, e-cigarettes);.

How the Study Was Run

The set-up was single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-05-06 with completion listed for 2030-03-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Average number of days to smoking relapse (time frame: From quit date to 6-month follow-up (about 6.5 months)).

It also tracked 3 secondary outcomes, for example Number of participants who self-report 7-day point prevalence abstinence, Number of participants who self-report 7-day point prevalence abstinence and Number of participants who self-report 7-day point prevalence abstinence.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Therapeutic nicotine (patch, non-peptide) in 600 people.

With 600 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.

Our Notes on the Compound

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

Related Pages

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.