Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

Launched by BAYLOR COLLEGE OF MEDICINE · Aug 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how brain connections are affected in people who are struggling with opioid use and have thoughts of suicide. Researchers want to understand the differences in brain activity between those who become compulsive users of opioids and those who do not, especially in relation to suicidal thoughts. The goal is to identify specific brain patterns that could help doctors better understand and treat these individuals.

To participate, you need to be between 18 and 60 years old, have used opioids, and currently have feelings of depression and active thoughts of suicide. Healthy individuals who have no history of serious medical issues are also welcome to join as a comparison group. Participants will undergo brain imaging and other assessments, and they should be comfortable discussing the study and providing consent. This research could lead to new insights into how substance abuse and mental health are connected, potentially improving treatment options for those affected.

Gender

ALL

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)