Safety and Efficacy Study of the NRT CQSS2 System for Smoking Cessation in Treatment-Seeking Subjects

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin.

However, side effects such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are commonly experienced by users of such systems.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 220 actual participants took part.

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: Ability to participate fully in all aspects of the study. Ability to understand and sign the study informed consent form. English-speaking, literate males and females. Age ≥18 years. Smokers consuming on average \>10 cigarettes per day for the past 6 months, confirmed by self report.

The full record lists 9 inclusion and 26 exclusion criteria; among the exclusions: subjects with tattoos that could interfere with skin assessments; subjects with:; moderately severe or severe depression, as defined by a patient health questionnaire (phq-9) total score of ≥10, or.

How the Study Was Run

Design: 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.

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

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2017-08-07 with completion listed for 2017-10-18.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Quit Rates for Smokers treated with the CQSS2 System vs NicoDerm CQ Patch.

It also tracked 1 secondary outcome, for example Number of participants with treatment-related adverse events as assessed on an 8-point Skin Irritation Assessment scale (0 to 7).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 220 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.