Actively Recruiting

Early Phase 1
Age: 18Years - 21Years
All Genders
Healthy Volunteers
ID05665465

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Led by Duke University · Updated on 2026-04-02

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how certain childhood experiences, called adverse childhood experiences (ACEs), affect brain function and reactions to nicotine in young adults who do not smoke. The study aims to understand why people with ACEs are more likely to start smoking and use other substances. It focuses on brain areas involved in reward and self-control by examining responses to nicotine exposure in a controlled setting. Participants will receive nasal sprays containing either a placebo or small doses of nicotine (0, 0.5, or 1 mg) during several visits. The study includes brain scans using functional magnetic resonance imaging (fMRI) while participants perform tasks related to reward and control. The study also involves sessions where participants choose to self-administer nicotine or placebo sprays, with careful monitoring by medical staff. Throughout the study, participants will attend seven visits including screening, training with a mock MRI, brain imaging, and nicotine exposure sessions. Researchers will collect breath and urine samples to check for recent smoking or substance use, as well as blood samples to measure nicotine levels. They will assess subjective effects of nicotine, brain activity changes, and reinforcing effects of nicotine nasal spray. The entire participation period spans several weeks with close safety monitoring.

CONDITIONS

Brief Title

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Who Can Participate

Age: 18Years - 21Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Generally healthy
  • Aged 18 to 21 years
  • Never smoked a full cigarette or used an equivalent amount of nicotine or tobacco products
  • No tobacco exposure in the past 3 years
  • Expired air carbon monoxide level of 3 ppm or less
  • Confirmation of non-smoking status from two collateral reporters
  • Breath alcohol value equal to 0.000
Not Eligible

You will not qualify if you...

  • Use of illegal drugs as shown by urine drug screen
  • History of illicit drug use more than 10 times in lifetime
  • Lifetime history of alcohol use disorder
  • Binge drinking more than 5 times per month over past 3 months
  • History of serious mental illness such as bipolar or psychotic disorders
  • Significant medical or unstable psychiatric disorders
  • Systolic blood pressure 140 mmHg or higher, or diastolic blood pressure 90 mmHg or higher
  • Heart rate 100 beats per minute or higher
  • Use of psychoactive medications in past 6 months
  • Conditions making fMRI unsafe (e.g., pacemaker)
  • Brain abnormalities including stroke, tumor, or seizure disorder
  • History of serious traumatic brain injury
  • Claustrophobia
  • Lack of firm resolve to avoid cigarette, e-cigarette, or tobacco use in the coming year
  • Pregnant, trying to become pregnant, or breastfeeding
  • Inability to understand written or spoken English
  • Inability to attend all experimental sessions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Training

Duration - 1 day

Participants complete training to prepare for MRI tasks and acclimate to the mock MRI scanner.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo neuroimaging scanning sessions to examine brain reactivity during reward, inhibitory control tasks, and rest.

1 visit (in-person)

Treatment

Duration - 3 separate visits over several days

Participants receive nicotine nasal spray or placebo during laboratory sessions and report subjective reactions.

3 visits (in-person)

Treatment

Duration - 1 day

Participants attend a final choice session to self-administer nicotine or placebo nasal spray.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

M

Maggie Sweitzer, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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