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NCT Number: NCT07112105

Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder

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.

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Key information

Conditions

Stimulant Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location contact

Jong H Yoon, MD

CONTACT

[email protected]

650-493-5000

Jong H. Yoon, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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 fMRI scans, presence of ferromagnetic material in their body or taking DAergic medications

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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 rTMS

Device

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.

Primary outcomes

  1. Number of Participants Relapsed

    Time frame: 3 months after last rTMS treatment

    Rate of stimulant use relapse compared between active vs. sham rTMS groups

Secondary outcomes

  1. Reward circuit function and signaling

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jong H Yoon, MD

CONTACT

[email protected]

(650) 493-5000

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Stanford University

Registry information

Acronym: VA-StARTS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 8, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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