The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 30 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
Subjects randomized to sham rTMS will undergo the same procedures on the same equipment as subjects assigned to active rTMS, but no active magnetic stimulation will be delivered.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Number of Participants Relapsed
Rate of stimulant use relapse compared between active vs. sham rTMS groups
Time frame: 3 months after last rTMS treatment
Reward circuit function and signaling
Before and after treatment, participants will undergo functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra will be measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling will be compared between active vs. sham rTMS groups.
Time frame: Within 1 week before rTMS treatment and within 1 week after rTMS treatment
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