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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: Recruiting Early Phase 1 study of Adverse Childhood Experiences and Nicotine Dependence, Cigarettes, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
subjective effects will be measured by the Nicotine Effects Questionnaire at the end of each fixed dose session. This scale measure positive reactions, negative reactions, and dizziness on a scale from 0-3 where 0 is none and 3 is intense.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nicotine nasal spray 0.5 mg
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-01-19 |
| Est. Completion | 2027-03-31 |
| Phase | Early Phase 1 |
What NCT05665465 shows while recruiting
NCT05665465 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 319-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Adverse Childhood Experiences
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05665465's enrollment target sits among peer trials
150 6th of 13 higher than 8 of 13 other Adverse Childhood Experiences trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adverse Childhood Experiences trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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