What is this study trying to find out about opioid use and suicidal behavior?

This study is examining how brain connections between specific regions may differ in opioid users who have suicidal thoughts compared to those who do not. Researchers aim to better understand the brain mechanisms involved in opioid abuse and suicide risk to help guide future treatments. The study is sponsored by Baylor College of Medicine.

Who may be eligible for this substance abuse and suicide clinical trial?

Adults aged 18 to 60 who use opioids and have depressive symptoms and active suicidal thoughts may be eligible. Participants must also be able to safely undergo brain imaging and stimulation procedures and provide informed consent. The study includes both opioid users and healthy controls. Please review eligibility criteria for more details.

Is there any cost to participate in this substance abuse and suicide clinical trial?

Study-related care, including the use of brain stimulation and imaging procedures and all trial visits, is provided at no cost. However, any personal travel or other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 64Years

All Genders

Healthy Volunteers

ID05489042

Brain Connectivity and Non-Invasive Brain Stimulation Treatment in Adults With Opioid Use and Suicidal Thoughts

Led by Baylor College of Medicine · Updated on 2025-04-04

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating how brain connectivity changes in people who use opioids and have suicidal thoughts. This study focuses on the connection between the orbitofrontal cortex OFC and the dorsal striatum, brain regions involved in reward, addiction, and mood control. The study aims to understand how these brain connections differ in opioid users with suicidal behaviors compared to those without, using advanced brain imaging and stimulation techniques. Participants will receive either active or sham repetitive transcranial magnetic stimulation rTMS targeting the OFC. The active rTMS involves five sessions of brief single pulses or short bursts of magnetic stimulation delivered in specific patterns, while the sham group receives five sessions of fake stimulation for comparison. The study uses interleaved TMS-fMRI to observe brain activity changes and assess how rTMS affects the targeted brain circuits. During the study, participants will undergo brain imaging with functional magnetic resonance imaging fMRI to measure connectivity between the OFC and dorsal striatum, as well as evaluations of psychiatric symptoms like opioid craving and suicidal thoughts. The main outcomes include changes in brain responses after rTMS and differences between opioid users and healthy individuals. Participation includes baseline and follow-up assessments to monitor these changes over time, with safety and adherence closely tracked throughout the study.

CONDITIONS

Brief Title

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Active Repetitive Transcranial Magnetic Stimulation	Sham Repetitive Transcranial Magnetic Stimulation	Standard Care (No rTMS)
What is it?	Active rTMS delivers repeated magnetic pulses to specific brain regions over five treatment sessions using standardized protocols.	Sham rTMS mimics the procedure and device without active magnetic stimulation, serving as an inactive control arm.	Standard care typically includes guideline-supported pharmacological treatment for depression, psychotherapy, and monitoring for suicidal thoughts; rTMS is not routinely used for opioid users with depression or suicidal thoughts.
Role in trial	Investigational treatment arm intended to test therapeutic effects on connectivity and clinical symptoms.	Control arm for comparison, used to distinguish effects of active rTMS from non-specific procedural effects.	Serves as external context; not part of the trial’s randomized control. Represents standard care outside the study.
Primary use	Studied as adjunctive therapy to improve brain connectivity and reduce depressive and suicidal symptoms in opioid users.	Used as a placebo control to benchmark changes observed under active stimulation.	Standard therapies are used to alleviate depression and monitor or reduce suicidal ideation among opioid users.
How is it given or performed?	Magnetic pulses are delivered to the brain at specified intensity and frequency over five sessions, following trial protocol (single pulse or theta-burst train).	Procedure follows similar session structure but without actual magnetic stimulation.	Patients typically receive oral antidepressants or psychotherapy as indicated and are monitored for depressive and suicidal symptoms.
Evidence status	Efficacy for opioid users with depression and suicidal thoughts is under clinical investigation; published evidence in substance use populations suggests rTMS alters neural connectivity and may reduce symptoms, but high-quality evidence in this exact group is not yet established.	Expected to have no direct therapeutic effect; serves as inactive control, though placebo effects are possible.	Pharmacotherapy and psychotherapy are established strategies with strong published evidence for improving depressive symptoms and reducing suicidal thoughts in opioid users.
Important limitations	Limited evidence in opioid-using, depressed, and suicidal populations; requires specialized equipment and personnel; possible safety concerns include seizure risk, headache, and discomfort.	Does not provide clinical benefit; subject to placebo effects; lacks blinding to physical sensations.	Some patients may not respond to initial treatment steps; opioid users with depression and suicidal thoughts face increased risk for poor outcomes, requiring careful monitoring. Relapse and treatment adherence are major clinical challenges.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 64Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male or female aged 18-60 years old
Participation in H-22611
WHO-ASSIST score of 4 or higher in the opioid category
Presence of depressive symptoms according to Patient Health Questionnaire (PHQ)-9
Active suicidal thoughts according to Suicide Behaviors Questionnaire-Revised (SBQ-R)
Able to understand and provide written informed consent
Female participants must not be pregnant or nursing during fMRI and rTMS
No contraindications to MRI (e.g., pacemaker, cochlear implants, metal implants)
No contraindications to TMS (e.g., no non-removable metal near head or within 12 inches of coil)
For healthy controls: no history of severe medical or neurological illness

You will not qualify if you...

Expected inability to complete the study protocol due to intolerance to rTMS
Unable to understand the study design and requirements
Unable to provide informed consent
Unstable medical conditions such as AIDS, acute hepatitis, active tuberculosis, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency
Pregnant or nursing female participants
Contraindications to MRI or TMS procedures
Non-English speaking individuals due to resource limitations

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 5 sessions over approximately 1 week

Participants receive 5 sessions of repetitive transcranial magnetic stimulation (rTMS) or sham rTMS targeting the orbitofrontal cortex to study changes in brain connectivity and psychiatric symptoms.

5 visits (in-person)

Follow-up

Duration - Up to 7 days after treatment

Participants are monitored for changes in functional connectivity and psychiatric symptoms after the rTMS treatment sessions.

1 visit (in-person)