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Behavioural Intervention

rTMS for Suicidal Ideation in Opioid Users

N/A
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be male or female aged 18-60 years old
Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and rTMS treatment;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial is investigating if a treatment targeting the OFC/dSTR connectivity will reduce compulsive reward-seeking behavior in patients with a history of opioid abuse and suicidal ideation.

Who is the study for?
This trial is for adults aged 18-60 with active suicidal thoughts, enrolled in The Menninger Clinic, experiencing depression, and have used opioids. They must understand the study and consent to participate. Women can't be pregnant or nursing. Participants cannot have metal implants that interfere with MRI or TMS procedures.Check my eligibility
What is being tested?
The study tests if Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, affects brain connectivity related to compulsive behavior and mood control in opioid users with suicidal tendencies compared to sham (fake) treatment.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. It's generally considered safe but might not be suitable for those sensitive to magnetic fields.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects
rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
5 sessions of active rTMS
Group II: Sham rTMSPlacebo Group1 Intervention
5 sessions of sham rTMS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,268 Total Patients Enrolled
6 Trials studying Suicide
54,103 Patients Enrolled for Suicide
American Foundation for Suicide PreventionOTHER
33 Previous Clinical Trials
9,695 Total Patients Enrolled
21 Trials studying Suicide
8,298 Patients Enrolled for Suicide
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,172 Total Patients Enrolled
3 Trials studying Suicide
275 Patients Enrolled for Suicide

Media Library

Repetitive Transcranial Magnetic Stimulation (rTMS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05489042 — N/A
Suicide Research Study Groups: Sham rTMS, Active rTMS
Suicide Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT05489042 — N/A
Repetitive Transcranial Magnetic Stimulation (rTMS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489042 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for enrollment in this medical trial?

"This clinical trial seeks 80 adults of both genders between 18 and 64 years old, who demonstrate depressive symptoms according to the Patient Health Questionnaire (PHQ)-9; have active suicidal ideation as evidenced by their Suicide Behaviors Questionnaire-Revised (SBQ-R) scores; are presently enrolled in The Menninger Clinic, possess sufficient comprehension of the consent form and provide written informed consent for study procedures. Female subjects must be non-nursing and not pregnant at times of fMRI experiments and rTMS treatment. Additionally, they cannot present with any MRI or TMS contraindications such as pacem"

Answered by AI

Are there still opportunities for potential participants to join the study?

"The clinical trial is actively seeking participants, as evidenced by the information available on clinicaltrials.gov. The first post regarding this study was made on April 1st 2022 with the most recent update being August 3rd of that same year."

Answered by AI

What is the sample size for this investigative research?

"Affirmative. Clinicaltrials.gov details that this research is proactively seeking participants, having been first posted on April 1st 2022 and last refreshed on August 3rd 2022. The study requires 80 individuals to be recruited from one site."

Answered by AI

Does this experiment include participants beyond a certain age?

"This clinical trial is looking for individuals aged 18-64 to participate as study participants."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
California
Texas
How old are they?
18 - 65
What site did they apply to?
The Menninger Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. The Menninger Clinic: < 24 hours
Average response time
  • < 1 Day
~18 spots leftby Jan 2025