Actively Recruiting

Phase Not Applicable
Age: 12Years - 14Years
All Genders
Healthy Volunteers
ID06977178

Adverse Adolescent Pathways to Substance Use

Led by University of North Carolina, Chapel Hill · Updated on 2025-05-18

180

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the relationship between anxiety symptoms and risky substance use behaviors in children aged 12 to 14. This study aims to understand how changes during adolescence affect brain connections and stress responses that may lead to early substance use. The study focuses on neural, physiological, and cognitive factors in youth who have not previously used drugs or alcohol. Participants will undergo a series of assessments including questionnaires, interviews, and neuroimaging while performing cognitive tasks. They will also take part in a mild stress test called the Trier Social Stress Test for Children, which involves public speaking and mental arithmetic to monitor heart rate and skin conductance. Caregivers will complete questionnaires as well. Data will be collected at baseline, 12 months, and 24 months, with a final online survey in year 5. Throughout the study, participants will be monitored for brain activity during various tasks using functional MRI, physiological stress responses, anxiety levels, and substance use patterns. Researchers will assess reaction times, brain signal changes, nervous system activity, hormone levels, and cognitive performance. The study includes multiple follow-up visits over two years and a long-term evaluation of symptoms and substance use at year 5, involving both the youth and their caregivers.

CONDITIONS

Brief Title

Adverse Adolescent Pathways to Substance Use

Who Can Participate

Age: 12Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Aged 12 to 14 years
  • Report symptoms of anxiety
  • Understand and sign assent; parents must sign permission and consent in English
  • Meet study hearing and vision requirements
  • Have not used substances such as alcohol, tobacco, or marijuana (substance-nafve)
Not Eligible

You will not qualify if you...

  • Have any foreign metal objects or implants that cannot be removed (e.g., bone screws, shunts, body piercing)
  • Diagnosed with psychosis or a severe emotional disturbance
  • Used alcohol, tobacco, or marijuana more than 3 times
  • Are pregnant or self-report pregnancy
  • Taking medications that affect cardiovascular function (e.g., beta blockers)
  • Current or past treatment with antipsychotic medication
  • History of head injury with loss of consciousness over 5 minutes
  • Planning to get non-removable metal braces
  • Impaired intellectual functioning (IQ below 70)
  • Past or current clinically significant central nervous system condition affecting brain imaging evaluations

AI-Screening

AI-Powered Screening

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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)

Monitoring

Duration - 2 years

Participants complete assessments including acute stress tasks, surveys, cognitive tests, stress physiological, clinical, and neuroimaging measures at baseline and two additional yearly visits to track anxiety symptoms, neural connectivity, and substance use risk.

3 visits (in-person) over 24 months

Long-term Monitoring

Duration - 1 day

Participants complete a final online exit survey in year 5 to evaluate clinical symptoms and substance use outcomes.

1 online visit

Trial Site Locations

Total: 1 location

1

The University of North Carolina at Chapel Hill School of Medicine

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

A

Aysenil Belger, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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