Neurobiology of Nicotine and Non-nicotine Components of Tobacco Addiction

What Was Tested

This registered phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

In the present study the investigators will measure the effects of nicotine and non-nicotine factors on brain function during cognitive processes that are differentially sensitive to these factors.

One process-continuous working memory (CWM)-is implemented via a network of frontal and parietal brain regions and is highly dopamine dependent.

It had four arms (groups): Nicotine Patch + Denic Smoking (experimental), Placebo Patch + Denic Smoking (experimental), Nicotine Patch + No Smoking (experimental) and Placebo Patch + No Smoking (experimental).

Subjects will wear a nicotine patch and smoke denic cigarettes for 24 hours prior to scan.

Subjects will wear a placebo patch and smoke denic cigarettes 24 hours prior to scan.

Subjects will wear a nicotine patch and not smoke for 24 hours prior to scan.

The registry classes the interventions as behavioral and drug.

More on the Plan

During scanning, participants will complete a laboratory based measure of continuous working memory (n-back)-a measure of continuous working memory-and the cue-reactivity task (CR)-a measure of responses to smoking cues.

Who Took Part

Enrollment: 147 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Between the ages of 18 and 55,. An afternoon expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation),. No interest in quitting smoking as measured by self-report, and. Right-handed as measured by a three-item scale used in their laboratory.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: inability to attend all required experimental sessions,; use of psychoactive medications,; use of smokeless tobacco,.

How the Study Was Run

It was run as a randomized, factorial and double-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Those kept unaware of assignments: participant and investigator.

It started in 2009-03 with completion listed for 2011-11.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Measure cue reactivity while subjects undergo a functional magnetic resonance imaging (fMRI) (time frame: 1.25 hours).

It also tracked 1 secondary outcome, for example Measure continuous working memory while subjects are scanned in a functional magnetic resonance imaging (fMRI).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 147 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.