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NCT03421210 · ClinicalTrials.gov registry record · Phase 4

Effects of Smoking Environments on Brain Reactivity

A Phase 4 study, sponsored by Duke University.

Completed
Registry status
Phase 4
Development phase
88
Enrollment target

NCT03421210 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 88 participants.

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The verdict

NCT03421210, a Phase 4 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 4
Development phase
88 participants
Enrollment target

Study Summary

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). Multiple methods will be used to test hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine correlation between brain responses to smoking environments (minus non-smoking environments) and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global Positioning System (GPS) analysis will primarily focus on locations where smokers smoke before and after quitting smoking. The investigators will evaluate whether EMA-assessed smoking intensity values are correlated with brain responses to these personal smoking environments.

Interventions

  • DRUG Nicotine patch

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2018-03-05
Est. Completion 2019-12-23
Phase Phase 4

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT03421210

The ClinicalTrials.gov registry entry for NCT03421210 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nicotine patch is the first listed.

NCT03421210 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03421210 about?

NCT03421210 is a clinical study titled "Effects of Smoking Environments on Brain Reactivity". 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 ra...

What is the current status of trial NCT03421210?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2018-03-05. Estimated completion is 2019-12-23.

What interventions are being tested in trial NCT03421210?

The interventions under investigation include: Nicotine patch (DRUG).

Who is sponsoring clinical trial NCT03421210?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.