Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05665465
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Adverse Childhood Experiences
  • Nicotine Dependence, Cigarettes

Eligibility Criteria

Sex
ALL
Age
18 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Nicotine nasal spray 0.5 mg — DRUG
    Participants will be administered nicotine nasal spray and provide subjective reactions
  • Placebo — DRUG
    Participants will be administered placebo nasal spray and provide subjective reactions

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
    Participants will be administered 2 nasal sprays with a combined nicotine content of 0mg nicotine, 0.1mL
  • Experimental: 0.5mg nicotine
    Participants will be administered 2 nasal sprays with a combined nicotine content of 0.5 mg nicotine, 0.1mL
  • Experimental: 1mg nicotine
    Participants will be administered 2 nasal sprays with a combined nicotine content of 1.0 mg nicotine, 0.1mL

Primary Outcome Measure

Subjective effects of nicotine nasal spray as measured by the Nicotine Effects Questionnaire [ Time Frame: during fixed dose session, approximately 3 hrs ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Maggie Sweitzer, PhD
[email protected]
919-668-0094

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By research site
Duke University Medical Center· Durham, NC

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