Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 21

Exploring how childhood experiences affect smoking risk in young adults

Official title: Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Run by Duke University · NCT05665465 · Data updated 2026-11-12

This study is trying to see how tough childhood experiences affect the brain's response to nicotine in young adults who don't smoke, to understand why they might be at a higher risk of starting to smoke.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 21 Years
SexAll
Enrollment150 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedJanuary 19, 2024
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedApril 2, 2026
Trial IDNCT05665465 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are generally healthy young adults aged 18-21 who have never smoked and have a history of adverse childhood experiences.

Probably not a fit

Patients with a history of serious mental illness or significant medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of adverse childhood experiences (ACEs) on brain function and responses to nicotine in nonsmoking young adults aged 18-21. Participants will undergo functional magnetic resonance imaging (fMRI) while performing tasks related to reward processing and inhibitory control, and will receive either a nicotine nasal spray or a placebo. The study aims to understand the neurobehavioral mechanisms that link ACEs to an increased risk of smoking. By analyzing brain responses and subjective reactions to nicotine, researchers hope to uncover insights into the relationship between childhood adversity and nicotine dependence.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into preventing smoking initiation among at-risk youth.

How similar studies have gone: While studies have explored the effects of childhood adversity on substance use, this specific approach using fMRI and nicotine exposure is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Duke University Medical Center
    Durham, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.