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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
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.
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.
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 belowSelect...
I am between 18 and 60 years old.
Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
2,587 Previous Clinical Trials
3,328,468 Total Patients Enrolled
6 Trials studying Suicide
54,103 Patients Enrolled for Suicide
American Foundation for Suicide PreventionOTHER
34 Previous Clinical Trials
9,762 Total Patients Enrolled
22 Trials studying Suicide
8,365 Patients Enrolled for Suicide
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,415 Total Patients Enrolled
3 Trials studying Suicide
275 Patients Enrolled for Suicide
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously participated in a trial called H-22611.You understand the consent form, can provide your consent in writing, and agree to complete all study procedures.You are eligible for TMS treatment, as long as you do not have any metal in your head or within 12 inches of the TMS coil.You have a high score on a test that measures your use of drugs like opioids, indicating that you may have a substance abuse problem.You are currently receiving treatment at The Menninger Clinic.I am between 18 and 60 years old.You can safely undergo an MRI scan without any metal objects in your body that could cause harm or interfere with the scan. You also need to pass some initial questions to make sure you are a good candidate for an MRI.I am not pregnant or breastfeeding.You have current thoughts of hurting yourself, according to a questionnaire.You are experiencing symptoms of depression as determined by the PHQ-9 questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Sham rTMS
- Group 2: Active rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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