Stress Test for Substance Addiction

(APSU Trial)

Overseen By Aysenil Belger, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Aysenil Belger, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for children aged 12-14 who show symptoms of anxiety. They must be accompanied by a legal caregiver and are willing to undergo questionnaires, interviews, neuroimaging during cognitive tasks, and physiological monitoring under mild stress.

Inclusion Criteria

Understands and signs 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 been diagnosed with psychosis or a severe emotional disturbance

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 used alcohol, tobacco, or marijuana more than 3 times

Treatment Details

Interventions

• Trier Social Stress Test

Trial Overview The study aims to understand how changes in the brain and body's response to stress during adolescence can lead to substance use due to anxiety. It involves non-invasive procedures like questionnaires, neuroimaging, heart rate and skin conductance monitoring.

Participant Groups

Group I: Trier Social Stress Test (TSST) Experimental Treatment 1 Intervention

The Trier Social Stress Test for Children (TSST-C) is a social stressor involving story telling in front of two neutral judges, preparation time and a cognitive stressor involving mental arithmetic-counting backward from 1023 by 13s. It is used to elicit physiological stress responses. The TSST-C is administered in 4 parts: an anticipatory stress phase (5 min to prepare the speech); the speech task (5 min), the arithmetic task (5 min), and the recovery phase (up through 40 min post-task).

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+