Examining brain connectivity in suicidal opioid users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Menninger Clinic
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Hyuntaek Oh, PhD
• Email: hoh@menninger.edu
• Phone: 713-275-5019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.