Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID05489042

Functional Connectivity Alterations in Suicidal Patients Among Opioid Users

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

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

A

American Foundation for Suicide Prevention

Collaborating Sponsor

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

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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)

Trial Site Locations

Total: 1 location

1

The Menninger Clinic

Houston, Texas, United States, 77035

Actively Recruiting

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Research Team

H

Hyuntaek Oh, PhD

T

Taylor Ly

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report.

A John Rush, Madhukar H Trivedi, Stephen R Wisniewski...

https://pubmed.ncbi.nlm.nih.gov/17074942