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Search / Trial NCT05665465

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Launched by DUKE UNIVERSITY · Dec 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how certain difficult experiences in childhood can affect the brain and influence a person's response to nicotine, which is the addictive substance found in cigarettes. The researchers want to understand why some people who had tough childhoods are more likely to start smoking. To do this, they will recruit healthy young adults aged 18 to 21 who have never smoked or used nicotine products. Participants will receive either a small dose of nicotine through a nasal spray or a placebo (a harmless spray that looks the same but has no active ingredients) while their brain activity is monitored using a safe imaging technique called fMRI.

If you or someone you know is interested, it’s important to know that participants must be in good health, not have used tobacco in the last three years, and have no serious medical or mental health issues. Throughout the study, participants will complete questionnaires and undergo brain scans while performing tasks. This research could help us learn more about the connection between childhood experiences and the risk of smoking, potentially leading to better prevention strategies in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. generally healthy
  • 2. 18-21 years of age
  • 3. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products
  • 4. no tobacco exposure in the past 3 years
  • 5. expired air CO level ≤ 3 ppm
  • 6. corroboration of non-smoking status from 2 collateral reporters
  • 7. breath alcohol value = 0.000
  • Exclusion Criteria:
  • 1. use of illegal drugs as measured by urine drug screen
  • 2. reported history of illicit drug use \> 10 times lifetime
  • 3. lifetime history of alcohol use disorder
  • 4. binge drinking \> 5 times per month over the past 3 months
  • 5. history of serious mental illness including bipolar or psychotic disorders
  • 6. significant medical or unstable psychiatric disorders
  • 7. systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg
  • 8. heart rate ≥ 100 bpm
  • 9. use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months
  • 10. presence of conditions that would make fMRI unsafe (e.g., pacemaker)
  • 11. brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)
  • 12. history of serious traumatic brain injury
  • 13. claustrophobia
  • 14. lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year
  • 15. pregnant, trying to become pregnant, or breastfeeding
  • 16. inability to understand written and/or spoken English language
  • 17. inability to attend all experimental sessions

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Maggie Sweitzer, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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