Stimulant Use Disorder
Conditions
Keywords
Magnetic resonance imaging, Transcranial magnetic stimulation, Intermittent theta burst stimulation, Dopamine, Reward processing
Brief summary
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.
Interventions
DEVICERepetitive transcranial magnetic stimulation (rTMS)
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.
DEVICESham rTMS
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.
Sponsors
VA Office of Research and Development
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.
Intervention model description
Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Stable medical health
Exclusion criteria
* 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 * Implants or medical devices incompatible with TMS * Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina * Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis * Other substance use disorder not in remission * Chronic or recurring Axis I psychotic disorders * For subjects participating in functional magnetic resonance imaging (fMRI) scans, presence of ferromagnetic material in their body or taking DAergic medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Relapsed | 3 months after last rTMS treatment | Rate of stimulant use relapse compared between active vs. sham rTMS groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reward circuit function and signaling | Within 1 week before rTMS treatment and within 1 week after rTMS treatment | 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. |
Countries
United States
Contacts
CONTACTJong H Yoon, MD
PRINCIPAL_INVESTIGATORJong H. Yoon, MD
VA Palo Alto Health Care System, Palo Alto, CA
Outcome results
None listed