Examining brain connectivity in suicidal opioid users

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

This study is trying to see if a brain stimulation treatment can help reduce cravings and suicidal thoughts in people who use opioids.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Baylor College of Medicine (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05489042 on ClinicalTrials.gov

What this trial studies

This study investigates the functional connectivity alterations in the brains of patients who use opioids and exhibit suicidal behaviors. It employs a combination of repetitive Transcranial Magnetic Stimulation (rTMS) and resting state functional magnetic resonance imaging (fMRI) to explore the therapeutic mechanisms affecting opioid cravings and suicidal thoughts. By targeting the orbitofrontal cortex (OFC) and observing changes in psychiatric symptoms, the study aims to provide insights into the neurobiological underpinnings of addiction and suicide. The research is designed to enhance understanding of how non-invasive brain stimulation can impact these critical issues.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-60 who are opioid users with depressive symptoms and active suicidal thoughts.

Not a fit: Patients who do not use opioids or do not exhibit suicidal behaviors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for opioid users experiencing suicidal thoughts and behaviors.

How similar studies have performed: Other studies have shown promise in using brain stimulation techniques for addiction and suicidal ideation, suggesting potential for success in this novel approach.

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 Center for Advanced MR Imaging (CAMRI);
* Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.).

Inclusion Criteria Healthy Controls:

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;
* No history of severe medical or neurological illnesses per history;
* 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 time of fMRI experiments;
* Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.): Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI);
* Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the TMS coil, etc.).

Exclusion Criteria:

Any potential subject who meets any of the following criteria will be excluded from participating in the study if s/he has

* In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to not tolerable to receive rTMS;
* Unable to understand the design and requirements of the study;
* Unable to sign informed consent for any reason;
* Has an unstable medical condition, including Acquired immunodeficiency syndrome (AIDS), acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency;
* Female subjects who are pregnant or nursing;
* Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI;
* Contraindications to the noninvasive brain stimulation (NIBS) (any types of non- removable metal in their head except the mouth, or within 12 inches of the coil, etc.) Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation;
* Non-English speaking subjects (we do not have the staff and resources to include other languages)

Where this trial is running

Houston, Texas

• The Menninger Clinic — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Hyuntaek Oh, PhD

Conditions: Substance Abuse, Suicide, Depression