Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Plain-language guide to NCT00289653: not phased interventional trial of Therapeutic nicotine (patch, non-peptide), 23 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00289653
Phase: not phased
Status: completed
Start: 2005-09
Completion (planned or actual): 2006-12
Participants: 23 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Nicotine Dependence
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had 1 arm (groups): single open-label treatment arm (experimental).

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: At least 19 years of age. Male or female. Have intention to quit smoking within the next 6 months. Smoke 10 or more cigarettes per day.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant; have any generalized skin disorders; are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

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

It started in 2005-09 with completion listed for 2006-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Carbon Monoxide Levels (time frame: measured at week 10).

It also tracked 1 secondary outcome, for example Smoking Cessation.

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 23 people.

Its size is small, so on its own it can only give an early look.

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.