Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

What Was Tested

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

It had six arms (groups): 1 (experimental), 2 (experimental), 3 (experimental), 4 (experimental) and 5 (experimental).

Nicotine patch alone treatment.

Nicotine lozenge alone treatment.

Nicotine patch + lozenge combination treatment.

The registry classes the interventions as drug.

More on the Plan

This research study will last for three years.

The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination.

The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people.

Who Took Part

1504 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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, single-group and double-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.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2004-09 with completion listed for 2010-08.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (time frame: 6 months post quit date).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1504 people.

With 1504 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.