Exploring how childhood experiences affect smoking risk in young adults

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

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

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 21 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT05665465 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

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

Where this trial is running

Durham, North Carolina

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

Study contacts

• Principal investigator: Maggie Sweitzer, PhD — Duke University
• Study coordinator: Maggie Sweitzer, PhD

Conditions Adverse Childhood Experiences; Nicotine Dependence, Cigarettes