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iCanQuit Smoking Cessation Among Hispanic Adults

Plain-language guide to NCT06811038: phase 3 randomized trial of Therapeutic nicotine (patch, non-peptide), 854 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06811038
Phase
phase 3
Status
not yet recruiting
Start
2026-10-15
Completion (planned or actual)
2029-07-01
Participants
854 (estimated)
Design
randomized, quadruple-blind, prevention
Conditions studied
Cigarette Smoking-Related Carcinoma
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Arm I (iCanQuit application) (experimental) and Arm II (iCanQuit application and NRT) (experimental).

The registry classes the interventions as device, drug and other.

More on the Plan

OUTLINE: Participants are randomized to 1 of 2 arms.

Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels.

After completion of study intervention, patients may be followed up at 12 months.

Who Took Part

Enrollment: 854 planned participants were the target.

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

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

Examples of who could join: Self-identify as Hispanic ethnicity. Age 18 and older. Smoking at least one cigarette per day in the past 30 days. Want to quit smoking within 30 days. Interest in learning skills to quit smoking.

The full record lists 16 inclusion and 6 exclusion criteria; among the exclusions: NRT CONTRAINDICATION: Heart attack in the last 2 months; NRT CONTRAINDICATION: Stroke in the last 6 months; NRT CONTRAINDICATION: Diagnosed arrhythmia or tachycardia.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-10-15 with completion listed for 2029-07-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): 30-day point prevalence abstinence (PPA) (time frame: At 12 months post randomization).

It also tracked 6 secondary outcomes, for example 30-day PPA, 24 hour PPA, 7 day PPA, Cost per quitter, Cost per life year gained and Cost per quality-adjusted life year (QALY) gained.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 854 people.

With 854 participants it is a large trial for this field.

Its status is not yet 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.