RecruitingNot ApplicableNCT05489042

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users


Sponsor

Baylor College of Medicine

Enrollment

80 participants

Start Date

Jan 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how brain function is affected in people who use opioids and are having thoughts of suicide. Using brain scans and a type of brain stimulation called rTMS, researchers hope to better understand and potentially treat suicidal thinking in this population. **You may be eligible if...** - You are between 18 and 60 years old - You have opioid use issues (based on a screening questionnaire) - You are experiencing depressive symptoms - You are currently having thoughts of suicide - You do not have metal implants that would prevent an MRI or brain stimulation - You are not pregnant or breastfeeding - You are enrolled in a related companion study (H-22611) **You may NOT be eligible if...** - You have an unstable medical condition such as active HIV/AIDS, hepatitis, tuberculosis, or serious heart, liver, or kidney disease - You have metal implants incompatible with MRI or brain stimulation - You are pregnant or breastfeeding - You are unable to provide informed consent - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)

5 Sessions of rTMS - brief single pulse TMS or short TMS pulse bursts consisting of 2-5 pulses delivered per second at a standard intensity. If a brief single pulse TMS is applied, a standard single pulse TMS procedure will be used - This procedure consists of 10 trains of 180 seconds duration and each train will be separated by at least 30 seconds. If short TMS pulse bursts are applied, a standard theta-burst TMS procedure will be used - This procedure consists of TMS triplets (i.e., 3 pulses) that repeat for 10 trains of a total duration of 40-190 seconds and these bursts will be separated by at least 6 seconds and each train will be separated by at least 30 seconds

DEVICEsham rTMS

5 sessions of sham rTMS


Locations(1)

The Menninger Clinic

Houston, Texas, United States

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NCT05489042


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