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NCT05665465
Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
Conditions: Adverse Childhood Experiences, Nicotine Dependence, Cigarettes
Sex: All
Ages: 18 Years – 21 Years
Healthy volunteers: 1
Phase: EARLY_PHASE1
Enrollment: 150
Sponsor: Duke University
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:generally healthy18-21 years of agenever smoked a full cigarette or used an equivalent amount of other nicotine or tobacco productsno tobacco exposure in the past 3 yearsexpired air CO level ≤ 3 ppmcorroboration of non-smoking status from 2 collateral reportersbreath alcohol value = 0.000Exclusion Criteria:use of illegal drugs as measured by urine drug screenreported history of illicit drug use > 10 times lifetimelifetime history of alcohol use disorderbinge drinking > 5 times per month over the past 3 monthshistory of serious mental illness including bipolar or psychotic disorderssignificant medical or unstable psychiatric disorderssystolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHgheart rate ≥ 100 bpmuse of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 monthspresence of conditions that would make fMRI unsafe (e.g., pacemaker)brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)history of serious traumatic brain injuryclaustrophobialack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming yearpregnant, trying to become pregnant, or breastfeedinginability to understand written and/or spoken English languageinability to attend all experimental sessions
Source: ClinicalTrials.gov (NCT05665465). StuddyBuddy aggregates publicly available trial information.