Strategies to Help Adult ED Patients Quit Smoking

Plain-language guide to NCT00297466: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 336 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00297466
Phase: not phased
Status: completed
Start: 2006-01
Completion (planned or actual): 2007-04
Participants: 336 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Tobacco Use
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

The registry classes the interventions as behavioral and drug.

More on the Plan

EDs, it may be possible to engage millions of smokers in tobacco cessation efforts.

The major purpose of this study is to examine whether a multicomponent intervention delivered in the ED by a Lay Educator to adult smokers interested in quitting is more likely to result in cessation than usual care.

A secondary goal is to test whether patients who present to the ED with a tobacco-related illness (as indicated by ICD9 code) are more likely to quit than ED smokers with a non-tobacco-related condition.

Who Took Part

336 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: \>= 10 cigarettes smoked daily. Being discharged from the ED. Contemplation or preparation stage of change. Speaks English or Spanish.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: being admitted to hospital; too ill to consent.

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.

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

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-01 with completion listed for 2007-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 3-month cessation rate.

It also tracked 3 secondary outcomes, for example 3-month quit attempts,, daily cigarette consumption, and stage of change assessment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 336 people.

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.

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.