Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers

What Was Tested

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

It had 1 arm (groups): Nicoderm patch first, then Aveva patch (experimental).

Each subject gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days).

The registry classes the interventions as drug.

More on the Plan

This research study is intended to determine the effect of heat on FDA-approved nicotine transdermal patches and whether the heat applied will result in more nicotine being absorbed through the skin than without applying heat.

This is important given that little is known about how the release of nicotine is affected by heat, particularly for generic products that are also available over the counter.

Who Took Part

The registry lists 10 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: 1\. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old. 2\. Subjects should be cigarette smokers who smoke at least 5 cigarettes per day for one year or more. 3\. Provide written informed consent before initiation of any study procedures. 4\. Available for follow-up for the planned duration of the study. 5\. Able to communicate well with the investigators.

The full record lists 17 inclusion and 34 exclusion criteria; among the exclusions: 1\. subjects who are nonsmokers or smoke less than 5 cigarettes per day; 2\. women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or on the morning of any procedure day; 3\. participation in any ongoing investigational drug trial or clinical drug trial.

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 2014-10 with completion listed for 2015-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Measurement of Maximum Serum Concentration (Cmax) (time frame: four procedure days for each participant).

It also tracked 1 secondary outcome, for example AUC.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Therapeutic nicotine (patch, non-peptide) in 10 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.