Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-21
SponsorDuke University

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.

Eligibility criteria

Qualifiers

generally healthy

18-21 years of age

never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products

no tobacco exposure in the past 3 years

Disqualifiers

use of illegal drugs as measured by urine drug screen

reported history of illicit drug use > 10 times lifetime

lifetime history of alcohol use disorder

binge drinking > 5 times per month over the past 3 months

Trial design

Treatments tested in this trial

  • Nicotine nasal spray 0.5 mg
  • Placebo

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator