NCT05665465 · Duke University
Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- use of illegal drugs as measured by urine drug screen
- reported history of illicit drug use \> 10 times lifetime
- lifetime history of alcohol use disorder
- binge drinking \> 5 times per month over the past 3 months
- history of serious mental illness including bipolar or psychotic disorders
- significant medical or unstable psychiatric disorders
- systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
- heart rate ≥ 100 bpm
- use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months
- presence of conditions that would make fMRI unsafe (e.g., pacemaker)
- brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)
- history of serious traumatic brain injury
- claustrophobia
- lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year
- pregnant, trying to become pregnant, or breastfeeding
- inability to understand written and/or spoken English language
- inability to attend all experimental sessions
Where
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations