Status:
RECRUITING
Adverse Adolescent Pathways to Substance Use
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
RTI International
Conditions:
Anxiety
Adolescent Development
Eligibility:
All Genders
12-14 years
Phase:
NA
Brief Summary
Purpose: This 5-year R01 study will elucidate the role of maturational change across adolescence in neural connectivity and physiological stress responses in the relationship between anxiety and adver...
Detailed Description
The conceptual model proposes that the relationship between anxiety symptomatology and Adverse Patterns of Substance Use (APSU: age of onset, cumulative exposure, severity, and polydrug use) is a func...
Eligibility Criteria
Inclusion
- Male or female
- 12-14 years old,
- Report symptoms of anxiety
- Understand and sign an assent, and parents will sign a permission and a consent document in English
- Meets study hearing and vision requirements
- Substance use naïve
Exclusion
- Has any foreign metal objects or implants as determined by the safety questionnaires (e.g., bone screws, shunts or body piercing that can't be removed, etc.)
- Has been diagnosed with psychosis or a severe emotional disturbance.
- Has used alcohol, tobacco, or marijuana more than 3 times.
- Is pregnant. Girls who self-report pregnancy may not participate in the stress evaluation or the MRI scan.
- Is taking any medications that directly alter cardiovascular function (e.g., propranolol or other beta blockers).
- Any current or lifetime treatment with antipsychotic medication.
- Has had a head injury that resulted in a loss of consciousness for more than 5 minutes.
- Is planning to get non-removable metal braces.
- Impaired intellectual functioning (full-scale intelligence quotient \<70).
- Past or current history of a clinically significant central nervous system that could confound brain imaging evaluations.
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06977178
Start Date
February 20 2024
End Date
June 30 2030
Last Update
May 18 2025
Active Locations (1)
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1
The University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599