Telephone Counseling and the Distribution of Nicotine Patches to Smokers

What Was Tested

The trial (phase 3) is built around Therapeutic nicotine (patch, non-peptide).

The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly.

Specifically, this study aims to: 1.

It had six arms (groups): Active patches and telephone counseling (experimental), Placebo patches and telephone counseling (placebo comparator), Telephone counseling (active comparator), Active patches and materials (active comparator) and Placebo patches and materials (active comparator).

Proactive Telephone Counseling and 8-weeks of nicotine patches.

Proactive Telephone Counseling and 8-weeks of placebo patches.

Proactive Telephone Counseling.

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

More on the Plan

Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year.

To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition.

The researchers hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves.

The researchers also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches.

Who Took Part

4200 actual participants took part.

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

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

Examples of who could join: \>= 18 years old. \>=6 cigarettes per day. Ready to quit within one month. First time quitline caller. Valid phone number.

The full record lists 10 inclusion and 3 exclusion criteria; among the exclusions: uses other form of tobacco; use of zyban or chantix.

How the Study Was Run

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

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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

It started in 2009-02 with completion listed for 2010-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Six-month Continuous Abstinence From Cigarettes (time frame: 7 months post enrollment).

It also tracked 1 secondary outcome, for example Number of Participants Quit for 30-days at 2-months Post Enrollment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 4200 people.

With 4200 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.