NCT07112105

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
40mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026Dec 2029

First Submitted

Initial submission to the registry

July 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

3.7 years

First QC Date

July 25, 2025

Last Update Submit

September 9, 2026

Conditions

Stimulant Use Disorder

Keywords

Magnetic resonance imagingTranscranial magnetic stimulationIntermittent theta burst stimulationDopamineReward processing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Relapsed

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

    3 months after last rTMS treatment

Secondary Outcomes (1)

  • Reward circuit function and signaling

    Within 1 week before rTMS treatment and within 1 week after rTMS treatment

Study Arms (2)

Active rTMS

EXPERIMENTAL

Receive active rTMS

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham rTMS

SHAM COMPARATOR

Receive sham rTMS

Device: Sham rTMS

Interventions

Sham rTMSDEVICE

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.

Sham rTMS
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.

Active rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jong H. Yoon, MD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong H Yoon, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This is a double-blind study in which participants, staff administering treatment, investigators, and outcome assessors are all masked to group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two groups to receive active or sham rTMS.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 8, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)