NCT06018727

Role Of Sensitivity to neuroEndocrine Systems in Social Decisions

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making. This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.

Detailed description

This study has two components. First, there will be a 60 minute online session. During this session, participants will first be asked to complete the informed consent process, a demographics and contact form, a series of questionnaires, a working memory assessment, and a HIPAA authorization. Researchers will also conduct a brief interview about the participant's medical history (including questions about mood, personality, and symptoms of borderline personality disorder), which is used to assess eligibility for participation in the study. If eligible to continue, participants will complete one 90 minute in-person experiment session. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine. Ingesting hydrocortisone and yohimbine will increase participants' neuroendocrine (hormone) levels, which naturally become elevated in response to stress. After ingesting either the placebo or hydrocortisone plus yohimbine, participants will complete a series of questionnaires on a computer as well as an online decision-making task. While completing the computer task, participants' heart rate and pupil size activity will be monitored using an ECG monitor and an eye tracker. Three salivary samples will also be collected during this session: one immediately before participants ingest the placebo or hydrocortisone/yohimbine combination and two immediately before and after participants complete the computer game. These salivary samples will be collected, stored, then assayed, a process that allows us to measure participants' cortisol levels, a hormone important for the body's stress response.

Conditions

• Borderline Personality Disorder

Interventions

Type	Name	Description
DRUG	Hydrocortisone	Hydrocortisone 20 mg capsule will be administered orally.
DIETARY_SUPPLEMENT	Yohimbine	Yohimbine 20 mg capsule will be administered orally.
DRUG	Placebo	Two placebos will be administered orally.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-08-31
• Last updated: 2024-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study