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 Depressive Disorder (MDD) experiencing suicidality.
Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Change in Scale for Suicidal Ideation Remission
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Change in Scale for Suicidal Ideation Change
A semi-structured interview for assessing suicidal ideation, min value=0, max value = 38. Higher score = worse outcome.
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
Change in Columbia - Suicide Severity Rating Scale Change
An interviewer-rated suicide risk assessment tool. Min value = 0, Max value = N/A. Higher score = worse outcome
Time frame: Change from baseline, to end of TBS treatment course (4 weeks), and at 1 month follow up
17-item Hamilton Rating Scale for Depression (HRSD-17) Change
A rating scale for measuring severity of depressive symptoms. Min value = 0 Max value = 52. Higher score = worse outcome
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Visual Analogue Scale for Opioid Cravings Change
A rating scale for subjective cravings to use opioids. Min value = 0 Max value = 100. Higher score = worse outcome.
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
Timeline Followback Change
Self-reported substance use over a designated period of time. Min value = 0 Max value = N/A. Higher score = worse outcome.
Time frame: Baseline, after TBS treatment course (4 weeks), and at 1 month follow up
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