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Recruiting NCT05489042

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

Trial Parameters

Condition Substance Abuse
Sponsor Baylor College of Medicine
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2022-01-04
Completion 2027-02-28
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS)sham rTMS

Brief 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 Criteria

Inclusion Criteria Opioid Use Patients: Each potential subject will be eligible for inclusion in this study only if the specific criteria listed below are met: * Be male or female aged 18-60 years old * Participation in H-22611; * Meets a World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST) score of 4+ in the opioid category; * Has depressive symptoms according to the Patient Health Questionnaire (PHQ)-9; * Has active suicidal thoughts according to Suicide Behaviors Questionnaire-Revised (SBQ-R); * Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures; * Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and rTMS treatment; * Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening magnetic resonance imaging (MRI) questions provided by the Ce

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