A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

What Was Tested

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

The overall purpose of this research is two-fold.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This will help identify individuals who are most in need of cessation intervention.

While all smokers need to quit, this evidence could ultimately be used to help focus treatment and motivate smokers and clinicians to intervene more intensively with patients at greatest risk.

All participants who enroll will complete questionnaires about their demographics, smoking history, withdrawal symptoms, affect, alcohol use, stressors, medication usage and diet.

They will all have carotid ultrasounds, pulmonary function tests, arterial tonometry assessments, and 12-lead ECGs.

Who Took Part

1086 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Smoke 5 or more cigarettes per day,. Desire to quit smoking but not be currently engaged in cessation treatment,. Be medically eligible to use either combination NRT or varenicline,. Have reliable phone access,. If female, must not be pregnant and must be willing to use an acceptable birth control method.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: all smoking participants from new and original cohorts will be excluded from the cessation trial for the following reasons:; end-stage renal disease with hemodialysis;; prior suicide attempts within the last 5 years or current suicidal ideation;.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2012-05 with completion listed for 2015-11.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (time frame: Assessed 26 weeks after the target quit day).

It also tracked 3 secondary outcomes, for example Number of Days to Relapse, Number of Participants With Initial Cessation in the First 7 Days Post-quit and The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1086 people.

With 1086 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.