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NCT05665465 · ClinicalTrials.gov registry record · Early Phase 1

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

A Early Phase 1 study of Adverse Childhood Experiences and Nicotine Dependence, Cigarettes, sponsored by Duke University.

Recruiting
Registry status
Early Phase 1
Development phase
150
Enrollment target
1
Study location

NCT05665465 is a Early Phase 1 study of Adverse Childhood Experiences and Nicotine Dependence, Cigarettes that is actively recruiting participants, run by Duke University. The registered enrollment target is 150 participants, below the 319-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05665465, a Early Phase 1 study of Adverse Childhood Experiences and Nicotine Dependence, Cigarettes, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
Early Phase 1
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and/or a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.

Conditions Studied

Adverse Childhood Experiences Nicotine Dependence, Cigarettes

Interventions

  • DRUG Placebo
  • DRUG Nicotine nasal spray 0.5 mg

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-01-19
Est. Completion 2027-03-31
Phase Early Phase 1

Sponsor

Duke University

1,725 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05665465

The ClinicalTrials.gov registry entry for NCT05665465 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 319-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (53% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Adverse Childhood Experiences appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05665465 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05665465 about?

NCT05665465 is a clinical study titled "Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking". The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and the...

What is the current status of trial NCT05665465?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 150 participants. The study started on 2024-01-19. Estimated completion is 2027-03-31.

What conditions does trial NCT05665465 study?

This clinical trial studies the following conditions: Adverse Childhood Experiences, Nicotine Dependence, Cigarettes.

What interventions are being tested in trial NCT05665465?

The interventions under investigation include: Placebo (DRUG), Nicotine nasal spray 0.5 mg (DRUG).

Who is sponsoring clinical trial NCT05665465?

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

Where is trial NCT05665465 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.