Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking (NCT05665465) | Clinical Trial Compass
RecruitingEarly Phase 1
Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
United States150 participantsStarted 2024-01-19
Plain-language 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.
Who can participate
Age range
18 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. generally healthy
. 18-21 years of age
. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products
. no tobacco exposure in the past 3 years
. expired air CO level ≤ 3 ppm
. corroboration of non-smoking status from 2 collateral reporters
. breath alcohol value = 0.000
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective effects of nicotine nasal spray as measured by the Nicotine Effects Questionnaire
Timeframe: during fixed dose session, approximately 3 hrs
2
Subjective effects of nicotine nasal spray as measured by a visual analog scale
Timeframe: during fixed dose session, approximately 3 hrs
3
Reinforcing effects of nicotine nasal spray
Timeframe: during choice session, approximately 4 hrs
4
Percent BOLD signal change in ventral striatum
Timeframe: baseline, prior to intervention
5
Percent BOLD signal change in inferior frontal gyrus