Identifying Treatments to Motivate Smokers to Quit

What Was Tested

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

At any given point in time, most smokers are not interested in making a serious quit attempt.

It had 16 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

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

More on the Plan

Interested patients were electronically referred to the research office.

Research staff contacted interested patients and assessed eligibility.

Eligible patients were invited to return to their primary care clinic to learn about the study, provide written informed consent, be randomized, and complete initial assessments.

A database created a schedule of intervention and assessment contacts, which guided treatment delivery by case managers.

Who Took Part

517 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: 18 years of age or older;. Report smoking at least 5 cigarettes per day for the previous 6 months;. Able to read and write English;. Available to take one phone call per week;. Not currently interested in quitting smoking (defined as would not like to try to quit in the next 30 days),.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: study candidate is a pregnant, trying to get pregnant, or nursing;; A history of psychosis or bipolar disorder; A history of skin or allergic reactions while using a nicotine patch.

How the Study Was Run

The set-up was randomized, factorial and single-blind.

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.

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

Those kept unaware of assignments: outcomes assessor.

It started in 2010-06 with completion listed for 2014-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change in Cigarettes Smoked Per Day (CPD) (time frame: Assessed at week 26 relative to baseline CPD).

It also tracked 1 secondary outcome, for example Average Number of Cigarettes Per Day in the Past Week.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 517 people.

With 517 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.