RECRUITINGEarly Phase 1INTERVENTIONAL

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Nicotine nasal spray 0.5 mg

Participants will be administered nicotine nasal spray and provide subjective reactions

DRUG

Placebo

Participants will be administered placebo nasal spray and provide subjective reactions

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States