Providing Free Nicotine Patches to Quitline Smokers

What Was Tested

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

The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care.

A second factor is counseling plus materials versus materials only.

It had six arms (groups): Material Group (no intervention), Materials plus Voucher (active comparator), Materials plus Patches (active comparator), Counseling (active comparator) and Counseling plus Voucher (active comparator).

Subjects will receive self-help materials.

Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches.

Subjects will receive self-help materials and a 2 week's worth of nicotine patches.

The registry classes the interventions as behavioral and drug.

More on the Plan

Tobacco smoking leads to nicotine dependence and serious health consequences.

It is well established that offering free NRT can attract many more smokers to call a quitline.

However, how much the offer of free NRT helps quitline callers quit successfully is less well documented.

There is currently no consistent guideline for quitline practice.

Who Took Part

The registry lists 3706 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 or older. First time quitline caller. Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches. English and/or Spanish speaking. Valid phone number.

The full record lists 9 inclusion and 3 exclusion criteria; among the exclusions: contraindication(s) to nicotine patches; uses a form of tobacco other than cigarettes; plans to use chantix.

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.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2013-04 with completion listed for 2014-11.

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 Months Prolonged Abstinence (time frame: Seven months post enrollment).

It also tracked 1 secondary outcome, for example Percentage of Smokers Making a 24-hour Quit Attempt.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 3706 people.

With 3706 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.