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.
Must be a U.S. Veteran
Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe
Last use of stimulants >2 and <8 weeks
Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)
Pregnant or lactating female
History of prior adverse reaction to Transcranial magnetic stimulation (TMS)
On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion > 400mg/day
Seizure disorder or conditions known to substantially increase risk for seizures
Parallel
Repetitive transcranial magnetic stimulation (rTMS)
DevicerTMS 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.
Sham rTMS
DeviceSubjects 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.
Number of Participants Relapsed
Rate of stimulant use relapse compared between active vs. sham rTMS groups
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.
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VA Office of Research and Development
Lead sponsor
Stanford University
Collaborator
