Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
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.
Conditions:
🦠 Adverse Childhood Experiences 🦠 Nicotine Dependence, Cigarettes
🗓️ Study Start (Actual) 19 January 2024
🗓️ Primary Completion (Estimated) 31 March 2027
✅ Study Completion (Estimated) 31 March 2027
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 21 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 December 2022
  • First Submitted that Met QC Criteria 12 December 2022
  • First Posted 27 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024