Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

What Was Tested

In this phase 3 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking.

It had two arms (groups): High-Intensity Aerobic Exercise (experimental) and Low-Intensity Aerobic Exercise (active comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

360 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: Adult (age ≥ 18);. High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);. Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;. Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;. Body mass index \< 40;.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months; receiving current intervention for smoking cessation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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

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 2023-12-27 with completion listed for 2029-03-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 7-day point prevalence abstinence (PPA) at 6-month follow-up (time frame: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)).

It also tracked 2 secondary outcomes, for example 7-day point prevalence abstinence (PPA) at 12-month follow-up and 7-day point prevalence abstinence (PPA) at 9-month follow-up.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 360 people.

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.