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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, 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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active rTMS 		Receive active rTMS
  • Device: Repetitive 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.
Sham Comparator
Sham rTMS 		Receive sham rTMS
  • Device: Sham 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.

Recruiting Locations

VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California 94304-1207
Contact:
Jong H Yoon, MD
(650) 493-5000
Jong.Yoon@va.gov

More Details

Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Jong H Yoon, MD
(650) 493-5000
Jong.Yoon@va.gov

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.