Smoking Cessation Intervention: Effectiveness in Primary Care

Plain-language guide to NCT00296647: phase 4 randomized trial of Therapeutic nicotine (patch, non-peptide), 1346 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00296647
Phase: phase 4
Status: completed
Start: 2004-09
Completion (planned or actual): 2009-07
Participants: 1346 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Tobacco Dependence
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had five arms (groups): patch (active comparator), nicotine lozenge (active comparator), bupropion (active comparator), patch + lozenge (active comparator) and buproion + lozenge (active comparator).

The registry classes the interventions as drug.

More on the Plan

This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study.

The cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Who Took Part

1346 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

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

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2004-09 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 6 Month Self-reported Abstinence From Smoking (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1346 people.

With 1346 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.