A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates.

The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches.

It had two arms (groups): Nicotine Patch (4 weeks) (experimental) and Nicotine Patch (8 weeks) (experimental).

Participants receive one 4-weeks supply of nicotine patches.

Participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1495 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: Who enroll in QuitLine services. Who do not require physician approval to obtain nicotine replacement therapy. Who are willing to receive the nicotine patch.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: those who do not complete the call in english.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 2010-03 with completion listed for 2012-03.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: 7-day smoking abstinence (time frame: 7 days). 6-month smoking abstinence (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1495 people.

With 1495 participants it is a large trial for this field.

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.