NCT05665465 Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
| NCT ID | NCT05665465 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Duke University |
| Condition | Adverse Childhood Experiences |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2024-01-19 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Maggie Sweitzer, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT05665465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 21 Years, studying Adverse Childhood Experiences. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05665465 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05665465 currently recruiting?
Yes, NCT05665465 is actively recruiting participants. Contact the research team at maggie.sweitzer@duke.edu for enrollment information.
Where is the NCT05665465 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT05665465 clinical trial?
NCT05665465 is sponsored by Duke University. The principal investigator is Maggie Sweitzer, PhD at Duke University. The trial plans to enroll 150 participants.