Recruiting

rTMS

Sponsor:

VA Office of Research and Development

Code:

NCT07112105

Conditions

Stimulant Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

Study Details

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.

Conditions

Stimulant Use Disorder

Study ID

NCT07112105

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 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

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active rTMS

Receive active rTMS

sham comparator: Sham rTMS

Receive sham rTMS

Interventions

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 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.

Primary outcome measure

  • Number of Participants Relapsed [ Time Frame: 3 months after last rTMS treatment ]

Central Contacts and Locations

Central contacts

Jong H Yoon, MD

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

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Jong H Yoon, MD

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

Principal Investigator:

Jong H. Yoon, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Magnetic resonance imaging
  • Transcranial magnetic stimulation
  • Intermittent theta burst stimulation
  • Dopamine
  • Reward processing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-01.