Status:
COMPLETED
rTMS for Suicidality in Opioid Use Disorder
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Major Depressive Disorder
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depr...
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently al...
Eligibility Criteria
Inclusion
- Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
- Between the ages of 18-60 years
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
- On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
- Baseline score of \>/=4 on the scale for suicidal ideation (SSI).
Exclusion
- Currently pregnant or intending to be pregnant during the duration of the study
- Bipolar disorder, any psychotic disorder or current psychotic symptoms
- Previous rTMS treatment
- Known active seizure disorder, significant head injury with an imaging verified lesion
- Unstable medical illness
- Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
- Participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04785456
Start Date
March 1 2022
End Date
March 1 2024
Last Update
March 5 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4