rTMS for Suicidal Thoughts in Opioid Users

This study is looking at how repetitive Transcranial Magnetic Stimulation (rTMS) might help people who use opioids and have suicidal thoughts or depression. rTMS is a treatment that uses magnetic pulses to stimulate specific areas of the brain. Researchers want to see if rTMS can change the connections between certain brain areas (the orbitofrontal cortex and dorsal striatum) that are involved in addiction and suicide. You might be able to join if you are 18-60 years old, use opioids, and have symptoms of depression. The study will compare people who receive active rTMS to those who receive a sham (inactive) rTMS. Success would mean seeing changes in brain activity and responses in those who received the active treatment.

Study design
This interventional study plans to enroll 80 participants. It compares active rTMS to sham rTMS.
What's involved
Participants will receive 5 sessions of either active rTMS or sham rTMS. The study measures will be taken at 1 day and 7 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes in brain activity at 1 day and 7 days after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05489042

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

Recruiting
NAAges 18–64InterventionalTreatment
Baylor College of Medicine
~80 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Repetitive Transcranial Magnetic Stimulation (rTMS)sham rTMS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects
Measured over 1 day
+1 more outcome measured
Substance Abuse
Suicide
Depression
1 sites across 1 states
Texas1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.).
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

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;
Non-English speaking subjects (we do not have the staff and resources to include other languages)
  • Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects1 day

    Changes in functional connectivity between opioid users and healthy subjects

  • rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation7 days

    Active vs sham rTMS