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NCT05489042 · ClinicalTrials.gov registry record · NA

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

A NA study of Depression and Suicide, sponsored by Baylor College of Medicine.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT05489042 is a NA study of Depression and Suicide that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 80 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05489042, a NA study of Depression and Suicide, is actively recruiting participants, sponsored by Baylor College of Medicine.

RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

Suicide is the 10th leading cause of death for Americans of all ages and more people in the United States now die from suicide than die from car accidents. Although death by firearm remains the most common cause of suicide in the United States, an intentional overdose of substance usage such as prescription opioids accounts for over 5,000 suicides per year. In 2017, more than 70,000 drug overdose deaths occurred, making it the leading cause of injury-related death, and well over half (67.8%) involved opioids. The dramatic increase in opioid overdose raises concerns about their contribution to suicidal outcomes (e.g., suicidal behavior, ideation, and attempts). Abuse of prescription opioids is characterized by the persistence of opioid use despite negative consequences. The neurobiology of opioid abuse involves the mesolimbic dopamine systems as the main neural substrate for opioid reward, and altered dopamine release in this system plays a role in opioid abuse. Moreover, the cortico-striatal system, especially the orbitofrontal cortex (OFC), has been associated with the abuse of many substances, including opioids and alcohol. Structural brain alterations in frontal areas, particularly the OFC, may cause executive control dysfunctions of mood which are highly associated with suicidal ideation. Recent preclinical work has shown that higher input from the OFC to the dorsal striatum (dSTR) is associated with compulsive reward-seeking behavior despite negative effects (e.g., punishment). In this study, the investigators propose that OFC/dSTR connectivity may be one neural differentiator that distinguishes between those who become compulsive users after initial opioid use and those that do not. Moreover, suicidal patients among those who become compulsive users may have higher OFC/dSTR connectivity compared to non-suicidal patients.

Interventions

  • DEVICE Repetitive Transcranial Magnetic Stimulation (rTMS)
  • DEVICE sham rTMS

Study Locations (1)

Texas

  • The Menninger Clinic - Houston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-01-04
Est. Completion 2027-03-31
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT05489042

The ClinicalTrials.gov registry entry for NCT05489042 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Repetitive Transcranial Magnetic Stimulation (rTMS) is the first listed.

NCT05489042 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05489042 about?

NCT05489042 is a clinical study titled "Functional Connectivity Alterations in Suicidal Patients Among Opioid Users". Suicide is the 10th leading cause of death for Americans of all ages and more people in the United States now die from suicide than die from car accidents. Although death by firearm remains the most common cause of suicide in the United States, an intentional overdose of substance usage such as pres...

What is the current status of trial NCT05489042?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-01-04. Estimated completion is 2027-03-31.

What conditions does trial NCT05489042 study?

This clinical trial studies the following conditions: Depression, Suicide, Substance Abuse.

What interventions are being tested in trial NCT05489042?

The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE), sham rTMS (DEVICE).

Who is sponsoring clinical trial NCT05489042?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05489042 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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