Effects of Smoking Environments on Brain Reactivity

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The goal of this study is to evaluate correlations between brain reactivity (as assessed via functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of smoking in a specific location.

The investigators will use ecological momentary assessment (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after quitting smoking.

The investigators propose to identify 48 regular cigarette smokers who will complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI session and 4 post-quit medication check sessions).

It had 1 arm (groups): Nicotine Replacement Therapy (other).

Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

The registry classes the interventions as drug.

Who Took Part

88 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Between the ages of 18 and 65. An expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \>1000 ng/mL (NicAlert = 6). Interest in quitting smoking within the timeframe of the experiment. Ability to identify 4 personal smoking and 4 personal non-smoking places. Right handed as measured by a three-item scale used in their laboratory.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: immediate or no desire to quit smoking;; inability to attend all required experimental sessions;; use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;.

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 2018-03-05 with completion listed for 2019-10-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures (time frame: 4 weeks).

It also tracked 2 secondary outcomes, for example Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire and Number of Participants Experiencing Relapse.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Therapeutic nicotine (patch, non-peptide) in 88 people.

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.