Nicotine Patch, Blood Flow and Oxidative Stress Study

Plain-language guide to NCT00954096: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 55 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00954096
Phase: not phased
Status: completed
Start: 2002-10
Completion (planned or actual): 2006-11
Participants: 55 (actual)
Design: randomized, double-blind
Conditions studied: Healthy
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).

This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.

It had 1 arm (groups): Transdermal nicotine patch or placebo (experimental).

The registry classes the interventions as drug.

More on the Plan

The molecular basis of smoking induced tissue injury remains unclear but considerable evidence supports a role for oxidant stress (OS).

Defects in endothelium dependant flow mediated vasodilatation (FMD) are seen in those at risk of or with overt vascular disease.

Cigarette smoking is highly addictive.

Thus there is interest in the use of extended NRT as a "safer" alternative to cigarette smoking.

Who Took Part

55 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Nonsmokers who have never smoked. Normal medical history. Normal physical examination. Normal laboratory data. Negative urinary pregnancy test for females.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: previous cvd; chronic medication use; history alcoholism.

How the Study Was Run

Design: randomized, single-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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 2002-10 with completion listed for 2006-11.

It ran at 1 site in United States.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 55 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.