NCT06977178 Adverse Adolescent Pathways to Substance Use
| NCT ID | NCT06977178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-02-20 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 adverse pathways to substance use (APSU). Participants: Children (N=200) aged 12-14 with symptoms of anxiety and their legal caregiver will be recruited from clinical and community sources. Procedures: Youth participants will complete several questionnaires and interviews, undergo neuroimaging while performing cognitive tasks, and have their heart rate and skin conductance monitored during a mildly stressful task. Caregivers will complete several questionnaires.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Aysenil Belger, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06977178 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 14 Years, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06977178 currently recruiting?
Yes, NCT06977178 is actively recruiting participants. Contact the research team at aysenil.belger@unc.edu for enrollment information.
Where is the NCT06977178 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06977178 clinical trial?
NCT06977178 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Aysenil Belger, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 180 participants.
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