This study aims to examine whether multiple spaced sessions of intermittent theta-burst transcranial magnetic stimulation (iTBS) induce anti-depressant responses and reduce opiate cravings in adults with opiate use disorder (OUD). Additionally, we hope to identify whether the effectiveness of iTBS is related to changes in functional connectivity between particular brain areas.
The proposed study aims to investigate the effectiveness of aiTBS applied to either the L-DLPFC or the ACC for reducing SI in individuals with OUD and identify neural functional connectivity changes underlying treatment response. 30 individuals with OUD who endorse suicidal ideation will be recruited. The accelerated iTBS treatment will involve 10 daily sessions of iTBS. Stimulation will be delivered to either the ACC or the L-DLPFC for 5 consecutive days. Suicidal ideation, depressive symptoms and opiate misuse will be measured before and after the 5-day stimulation course. Functional magnetic resonance imaging (fMRI) scans will also be carried out before and after stimulation to examine aiTBS-induced changes in neural functional connectivity. Changes in suicidal ideation, depressive symptoms and opiate misuse will be measured using both clinician-rated and self-report assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)
Stanford University
Palo Alto, California, United States
Change in Beck Scale for Suicidal Ideation (SSI) score
19-item clinician administered assessment to measure the intensity, pervasiveness, and characteristics of suicidal ideation in adults. Scores range from 0-38.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Columbia Suicide Severity Scale (C-SSRS) score
Self-report measure for suicidal ideation
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Obsessive compulsive drug-use scale (OCDUS) score
Self-report measure of drug craving. This questionnaire will be adapted to make it specific for opiate use.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
Change in Beck Depression Inventory II (BDI-II) score
The Beck Depression Inventory (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)
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Change in resting-state functional connectivity.
Resting-state fMRI scans will be conducted before and after the course of aiTBS to examine changes in resting-state functional connectivity.
Time frame: After all stimulation sessions have been completed (approximately 48 hours after the final session)